Performance Improvement 1997


Chapter III

Agency Evaluation Activities

The 11 agencies of the Department of Health and Human Services (HHS) and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the Office of Public Health and Science (OPHS) in the Office of the Secretary each maintains its own evaluation program--including the functions of evaluation planning and policy review, quality assurance through technical review, project coordination and management, dissemination of reports, and utilization of results. This chapter provides an agency-by-agency summary of the evaluation activities. Each summary begins with an overview of the relevant evaluation program, describing its philosophy, policies, and procedures. Next is an overview of the major evaluations completed in fiscal year (FY) 1996 and the evaluations that are currently in progress. Finally, each agency offers a discussion of new directions for its evaluations, including priorities for future program and policy evaluation projects. Abstracts and contact persons for all evaluations completed in FY 1996, organized by agency, are presented in appendix A. Listings by agency of all evaluations in progress are located in appendix B.

Administration for Children and Families

MISSION: To promote the economic and social well-being of families, children, individuals, and communities.

Evaluation Program

The Administration for Children and Families (ACF) administers a broad range of entitlement and discretionary programs, including programs designed to move families from welfare to work (Temporary Assistance for Needy Families); child support; children and family services (Head Start, Child Welfare, Family Preservation and Support, youth programs); four block grants; and special programs for targeted populations, such as the developmentally disabled, immigrants, and Native Americans.

The objectives of ACF's evaluations are to furnish information on designing and operating effective programs; to test new service delivery approaches, building on the success of completed demonstrations; to apply evaluation data to policy development, legislative planning, budget decisions, program management, and strategic planning and performance measures development; and to disseminate findings of completed studies and promote application of results by State and local governments.

ACF actively engages with other Federal agencies, State and local policy and program officials, national organizations, foundations, professional groups and practitioners, and consumers to maintain currency on the emerging issues affecting its programs and to identify questions for evaluation studies. Systems changes and how they affect vulnerable populations, particularly the well-being of children, are of primary concern. The movement toward devolving responsibility for health and human services to State and local organizations--in particular, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996--offer both tremendous opportunities and unprecedented challenges in redefining and implementing services to families.

Evaluation study designs are carefully negotiated with the States and other interest groups. Studies are frequently funded as joint ventures with ASPE and other Federal agencies and foundations. Such collaborations enable efforts that are better informed, more representative of varying perspectives, and larger in scale. Proposals are reviewed by multidisciplinary experts. Work groups of various kinds are used throughout the projects to monitor progress and to advise on refinements in designing and presenting the findings.

Summary of Fiscal Year 1996 Evaluations

ACF's major evaluations are linked closely to its two strategic goals:

Described below are several major evaluations completed by ACF in FY 1996 that relate to these two strategic goals.

Economic Independence and Productivity of Families

Two studies addressed child support enforcement issues. First, Evaluation of Child Support Guidelines, highlighted in chapter II, evaluated the impact of shifting from voluntary to presumptive guidelines using the Current Population Survey Child Support and Alimony Supplement of 1992. Little impact on child support orders was found when States treated guidelines as presumptive rather than voluntary. Review of State studies of deviations from guidelines revealed that while deviation ranges from 3 percent to 81 percent, most States deviate in 25 percent of cases or less.

Second is an evaluation also highlighted in chapter II, Evaluation of Child Access Demonstration Projects: Report to Congress. This ACF Office of Child Support Enforcement report evaluates different forms of interventions to bring noncustodial parents closer to their children after divorce and separation. The interventions included mediation, parenting training, counseling, enforcement of visitation, and monitoring of visitation. The report found that mediation where both parties attended resulted in parenting plans in 65 to 70 percent of the cases. These parenting plans stimulated more visitation by noncustodial parents and better compliance with child support. A majority of both parents were satisfied with mediation. Other forms of intervention for more longer term and problematic cases did not register impact.

Healthy Development of Children and Families

Two evaluations completed during FY 1996 focused on ACF's Head Start program. First, Survey of Head Start Family Self-Sufficiency Initiatives explored ways programs could work with families to improve employability and literacy and deal with substance abuse. The study found that Head Start programs use formal surveys and assessments to identify a family's need for literacy and employability services but assess the need for substance abuse services more informally. Also, most program directors perceive the greatest need for employability services and the least need for substance abuse services.

Second, Survey of Head Start Family Self-Sufficiency Initiatives: Case Studies in Six Communities found that although most program directors were concerned about substance abuse and its effect on families, assessing and meeting families' service needs was difficult. According to the case studies, program directors believe their Head Start families need literacy services, although the underlying causes of illiteracy vary across sites. The six programs recognized and addressed employability in varying ways. For example, some programs offered information and referral, but only when parents requested assistance.

Several evaluation projects were targeted to programs for family members at risk, National Evaluation of Home-Based Services Programs for Runaway Youth reports on five demonstration programs--Baltimore, Maryland; Nashville, Tennessee; Kauai, Hawaii; San Diego, California; and Tucson, Arizona--targeting at-risk youth in dysfunctional families. In each, short-term interventions were applied to link the families to existing community resources. The projects reported difficulties in dealing with multiproblem families, lack of community resources, lack of support from other community agencies, and staff turnover. Effective service practices included bilingual and culturally sensitive staff, round-the-clock staff availability, and using a cotherapist approach.

Second, Gang Families in a Public Housing Project studied families having more than one gang member in a low-income Mexican-American community in Los Angeles. The project studied relationships among macrostructural and economic forces and household organization, family childrearing practices, sibling and relational influences, socialization of street children, culture and traditions, and levels of acculturation, especially in the colonization or marginalization process. The study identified family patterns and processes leading to gang membership and provided a better understanding of the dynamics of families with more than one gang member, how childrearing practices and street culture are transmitted to children, and how gang habits and values are transmitted among family members.

Length of Service and Cost-Effectiveness in Four Family-Based Placement Prevention Programs used an experimental design to study the impact of length of service on outcomes in family preservation programs in Portland and Pendleton, Oregon, and Baltimore, Maryland. The study found that, overall, participants (a total of 460 families) experienced low out-of-home placement rates, low rates of maltreatment, and significant improvement in family, parent, and child functioning. Six-month periods of in-home family treatment provided to families with older children and significant histories of prior services were the most effective.

Last, Final Evaluation Report for the Case Management Enhancement Project at the East Orange District Office of the New Jersey Division of Youth and Family Services (DYFS) documents a 4-year test of the effectiveness of a personal computer-based system to record child protective services case flow information. The overall impact has been to facilitate communication between caseworkers and supervisors, office staff, and outside agencies. Supervisors can now examine case records directly from their PC's, identify problems, assess risks, consult with caseworkers, and redirect case management in a timely manner; the network fax is used to transmit information directly from the computer. The Deputy Attorney General's office in Essex County is able to transmit affidavits, court documents, and complaints by computer sharply reducing the time needed to edit and finalize documents. East Orange office staff can also notify the prosecutor about child abuse and neglect cases on a timely basis. The project positively affected staff knowledge and skill levels and strengthened their motivation to tap the potential of computer technology. The DYFS client-tracking system has already proven its replication potential, both within the State of New Jersey and beyond. The experiment was expanded to all 39 district offices in New Jersey; Connecticut and Wisconsin have inquired about the East Orange system.

Evaluations in Progress

Described below are some of ACF's evaluations in progress that relate to the strategic goals.

Economic Independence and Productivity of Families

One study is looking at child support enforcement issues. Arkansas Prenatal and Postnatal Paternity Project tests the success of in-hospital and postnatal establishment of paternity. Early findings indicate the following: (1) Paternity is established in about half the cases; (2)38 percent of established paternities are for children in the IV-D caseload (Title IV, Part D of the Social Security Act authorizes Federal matching funds to be used for support obligations by locating nonresident parents, establishing paternity, establishing child support awards, and collecting money.); (3) 30 percent of child support cases receive some financial support; (4) 27 percent of child support paternity cases had closed; (5) 95 percent of paternities were established within 30 days of birth; and (6) 44 percent of parents who acknowledged paternity were cohabiting at the time of birth. Mothers at prenatal clinics were generally Medicaid-eligible and poor. Seventy-five percent of them said they wanted paternity established when their child was born and predicted that 71 percent of fathers would acknowledge their paternity; however, only 32 percent of the fathers actually signed paternity acknowledgments. Twenty-five percent of mothers at prenatal clinics did not want to establish paternity for reasons that included the following: (1) not wanting the father involved; (2) the father already gives money to the mother; (3) the mother does not know the location of the father; (4) the mother fears the father's reaction; (5) the mother does not know the identity of the father; (6) the mother sees no reason to establish paternity; or (7) the mother does not want to lose benefits. Programs to establish interstate paternities at the borders and programs to provide job and social services for unemployed fathers both succeeded. Models for deemphasizing child support and the use of child support staff were unsuccessful.

Two ACF studies under way address parenthood in welfare families. First, Responsible Fatherhood: Theoretical and Empirical Foundations for Policy and Program Development, a joint project with ASPE, focuses on a wide range of fathers, including disadvantaged, never-married, noncustodial fathers; separated or divorced noncustodial fathers; and fathers living with their children. By developing a theoretical underpinning to guide empirical research, program development, and program evaluation, this project intends to help inform policymakers about what is necessary to enable fathers to support and nurture a child.

A second study, Home Visitor Services Demonstration: Home Visiting for Teen Parents Required to Participate in JOBS, is testing the effectiveness of combining the Job Opportunities and Basic Skills Training (JOBS) Program with weekly home visits by paraprofessionals. The first-time teen parent welfare recipients are required to participate in education, training, and employment-related activities through the JOBS program, including home visiting. This controlled experiment is designed to evaluate whether home visiting helps teen parents to increase their participation in JOBS activities; improve parenting; experience fewer repeat pregnancies and births; and increase the use of preventive health care (including immunizations) both for themselves and their children. The evaluation is funded by ACF and the Henry J. Kaiser Family Foundation.

Eleven ACF evaluations projects relate to the Empowerment Zone/Enterprise Community Initiative. The Office of Community Services supports evaluations of 10 projects funded under the Job Opportunities for Low-Income Individuals (JOLI) Program. ACF also provides training and technical assistance to JOLI grantees. The services will help the grantees develop project designs and finalize evaluation plans.

Bridgeport Artisan Center, a project of Action for Bridgeport Community Development and its collaborative network of public and private agencies, is creating jobs and enterprise opportunities for low-income artisans in the inner city and surrounding neighborhoods of Bridgeport, Connecticut, an Enterprise Community.

Through its Harlem Railyards Transportation (HRT) Program, the South Bronx Overall Economic Development Corporation provides well-paying employment and business development opportunities for at least 102 recipients of Aid to Families with Dependent Children (AFDC) and other low-income individuals in the New York City Empowerment Zone. The HRT program, a not-for-profit trucking venture, operates a cost-effective transportation system that transfers loaded rail cars to trucks for delivery to New York City area businesses.

Venture, a highway construction program of the Rural Advancement Fund, trains 100 AFDC recipients for highway construction careers in three North Carolina counties. Venture capitalizes on Federal and State highway construction mandates aimed at employing AFDC recipients and other low-income people, particularly women and minorities.

JOLI Project of the Women's Self-Employment Project (WSEP) grows microenterprises, some incubated under a previous JOLI grant, to provide employment for AFDC recipients in Chicago, Illinois. The project identifies up to 30 employers to receive technical assistance aimed at expanding their businesses and creating 100 new jobs. WSEP increases access to financial services--such as loan capital, savings, and investment vehicles--by providing loans through its Revolving Loan Fund.

JOLI Project is enabling Bethel New Life to expand its 10-year-old Chicago home care service and to create 40 new upwardly mobile jobs. Bethel New Life plans to increase business by 25 percent by broadening its service population and diversifying its payer mix to include private-pay individuals and managed care provider contracts. It also plans to establish a career ladder to advance people from welfare to minimum-wage jobs as homemakers or home health aides and to living-wage jobs as certified nurse assistants, allied health workers, licensed practical nurses, and registered nurses.

Avenues (Avenidas), a project of the Mi Casa Resource Center for Women in Denver, Colorado, trains low-income persons, primarily women, for jobs and apprenticeships in highway construction and maintenance. Recruiters target the unemployed, public housing residents, and homeless persons. Keys to the project's success are a steering committee of collaborators to guide program implementation and facilitate job placements; motivational marketing and outreach to develop interest in nontraditional employment; comprehensive assessment, case management, and linkage to supportive services; a rigorous 6-week training program; and peer support and mentors.

Green Institute's JOLI Project is creating new job opportunities for 100 low-income residents in the Phillips neighborhood of Minneapolis, Minnesota, through the incubation of green businesses. The project focuses on five areas: (1) creating jobs that build on the success of the Green Institute's ReUse Center; (2) an incubator program for businesses that develop new products from industrial waste products; (3) businesses offering products and services to promote energy efficiency and conservation; (4) a program for youth entrepreneurs to develop environmental businesses and services through the Science Magnet Program at South High School; and (5) businesses focused on environmental technology and alternative energy that also provide better paying unskilled and semiskilled jobs.

Through Project RISE, Yakima Valley Opportunities Industrialization Center is expanding its housing development company into the Yakima Valley Rural Enterprise Community by creating 16 permanent, year-round jobs and safe, affordable housing for low- and moderate-income families. The project targets at-risk youth, public assistance recipients, displaced workers, and individuals enrolled in the JOBS program or in a program funded by the Job Training Partnership Administration. In 3 years, 56 homes will be constructed, weatherized, or rehabilitated on 8 acres developed by the project.

JOLI Project of Black Dollars Days Task Force in Seattle, Washington, is creating 71 jobs through three businesses: (1) NW ServiceMaster, a cleaning franchise expansion of the Handyman Connection, which provides JOLI participants opportunity for self-employment; (2) a new home health services business; and (3) a new driving and delivery service cooperative. The project is based on the Task Force's Multifaceted Business Development program, bringing together public-private partnerships, streamlined resources, and effective skills training to help people make the transition from welfare to self-sufficiency.

HOMECARE Co-op is a JOLI project of the San Jose Development Corporation. This self-employment house-cleaning services, business training, and business cooperative for AFDC recipients in Santa Clara County, California, is creating 40 new business enterprises which are, in turn, creating 60 new full-time jobs.

National Study of Protective, Preventive Reunification Services Delivered to Children and Their Families will examine the number and percentages of children and families in the child welfare system receiving protective, preventive reunification, out-of-home care, or aftercare services. The study will also obtain national data on the number, types, and dynamics of the services provided. Researchers will abstract case records on a nationally representative sample of 3,000 children and their families served by public child welfare agencies.

Foster Youth Mentors project is examining factors characteristic of successful relationships between foster youth and older citizen mentors by comparing 250 successful matches with 250 unsuccessful ones. Data is being collected on the characteristics of mentors, foster youth, and the mentoring program itself. Findings to be disseminated to independent living programs throughout the United States are expected to facilitate the use of mentors in older youths' transition from foster care.

Last, Evaluation of the Impact of Homelessness on ACYF Programs will identify service demands on ACYF programs serving homeless families, children, and youth; key strategies for increasing the effectiveness of ACYF programs; and methods to help reduce the risk of homelessness. Data will be collected from 40 communities in which a small-scale longitudinal study was done of homeless people and from case studies in five local programs.

Healthy Development of Children and Families

ACF has several studies under way that address Head Start issues. First, Descriptive Study of the Head Start Health Component describes health-screening, examination, referral, treatment, and follow-up procedures across four domains of the Head Start health component: medical, dental, nutrition, and mental health. Case records of 1,200 4-year-old children enrolled in a national sample of 40 randomly selected Head Start programs were reviewed, and parents were interviewed concerning their child's health status and health services utilization patterns.

Next, through a consortium of local evaluators, the Evaluation of the Head Start Family Service Center Demonstrations project, conducted by Abt Associates, Inc., is evaluating 41 Family Service Center Demonstrations. The project focuses on how Head Start can collaborate with community programs to help meet the needs of Head Start families that must deal with problems like illiteracy, substance abuse, and unemployment.

The Study of the Characteristics of Families Served by Head Start Migrant Programs is profiling Head Start migrant families in the main migratory streams; identifying unique services issues; documenting the availability and coordination of services for Head Start families during migration; and providing a national estimate of the number of eligible migrant children. Findings will inform policy decisions on both Head Start migrant programs and the new Early Head Start program for infants and toddlers.

The Early Head Start Research and Evaluation project is evaluating the effectiveness of the Early Head Start (EHS) program in 15 diverse communities. The study examines child, family, staff, and community outcomes in a sample of 3,400 children and their families, randomly selected into project and comparison groups when the mothers are pregnant or before the children reach the age of 12 months. Children, families, and child care environments will be assessed when children are 14, 24, and 34 months of age. Service use interviews will be conducted semiannually and programs visited annually. The study will produce the following reports: (1) Descriptive Study of EHS Programs; (2) Study of Program Variations; (3) Pathways to Early Head Start Quality; (4) Interim Study of Outcomes; (5) Longitudinal Study of EHS Outcomes; and (6) Selected Policy Papers.

Descriptive Study of Families Served by Head Start is examining policy-relevant issues with a nationally representative sample of families served by Head Start in 40 programs across the country. Employing survey and case study methods, the project is charting families' demographics, strengths, needs, expectations, and experiences in Head Start and programmatic efforts to join in partnership with families.

The National Child Welfare Research Center in the School of Social Welfare at the University of California, Berkeley, will serve as a knowledge-building and information-disseminating resource for improved child welfare services. The Center will give special attention to (1) child abuse and child welfare; (2) family preservation and maintenance; (3) foster care and adoption; (4) drug- and AIDS-affected children; and (5) organizing, financing, and evaluating child welfare services.

One ACF project focuses on family protective services. Evaluation of Nine Comprehensive Community-Based Child Abuse and Neglect Prevention Programs, a contract with CSR, Incorporated, is (1) designing and implementing a process and impact evaluation of nine comprehensive community-based child abuse and neglect prevention projects funded by the National Center for Child Abuse and Neglect; (2) providing technical assistance to the projects in meeting evaluation requirements; and (3) helping the programs design and implement their own internal program evaluations. Because each project has up to 10 service components, many differing across projects, the contractor has developed a series of experimental designs for each service component.

Two ACF studies are looking at family services from an international perspective. First, Transfer of International Innovations--Development of a Clinical Monitoring System to Support Foster Care in Michigan features a computerized system based on a model combining structured and systematic monitoring of each individual child with the aggregation of this information across the whole agency. Developed and now mandated in Israel, and modified for the U.S. foster care system, the system provides an integrated response to the needs of all partners in the agency, including administrators, managers, and policymakers.

A second project, Social and Educational Development of Tribal-Based Communities of the Sonoran and Neger Deserts, is a knowledge-transfer project assessing the application of a preteen Bedouin Arab dropout prevention program in a tribal community in the Negev Desert of Southern Israel to the Pascua Yaqui Indian Tribe in the Sonoran Desert of Southern Arizona. The assessment will examine the effectiveness of a cooperative community-university model for empowering economically disadvantaged minority communities to respond to the unique needs of their at-risk children.

Two ACF projects address cross-cutting issues of substance abuse treatment and gang membership. The first project, Women and Infant Nurturing Services (WINGS), is designed to counteract the upward spiral of female incarceration and substance abuse. This demonstration project at the Rose M. Singer Correction Facility on Riker's Island, New York City, targets pregnant, substance-abusing inmates and uses incarceration as a point of treatment intervention. The evaluation tests the effectiveness of a comprehensive service program, including substance abuse treatment, prenatal health and nutritional care, HIV education, parenting classes, mental health services, and assistance with entitlement preparation.

The second project, Factors Related to Gang Membership Resistance, is gathering data on gangs from two contrasting Los Angeles communities, one with higher-than-average Hispanic and African-American gang activity, the other with lower-than-average gang activity. The project is designed to increase understanding of how youth in urban areas with high levels of street gang activity avoid gang involvement. Expected products include replicable interview protocol, data tapes for other researchers, a final report including implications for prevention programming, and plans for extended validation and replication.

New Directions for Evaluation

ACF's evaluation activities will focus on questions of family economic independence and child well-being that arise from States exercising their new authority to determine public assistance policy and program design under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. Key questions will concern not only issues of cash assistance and employment policy but also a range of other issues, including interactions among public assistance systems and child and family welfare programs. Assessing the impact of welfare reform on low-income families calls for continuing efforts to develop measures of child well-being; to explore administrative data bases as informational sources for evaluation; to identify methods for measuring outcomes and performance; to stimulate the field to benchmark, measure performance, and track results; and to provide information rapidly to local and State decisionmakers and to national associations.

Initiating and completing evaluations of programs begun as State welfare reform demonstrations is necessary to provide timely information about public assistance strategies and to add to the knowledge base for Federal, State, and local policymakers. Principal descriptive questions include the following: How are Temporary Assistance for Needy Families (TANF) programs implemented at the State and local levels? What is the extent of devolution of decision making to local government? How are child care supply and quality affected? Impact analyses of key policies and interventions (e.g., income disregard strategies and time limits) must follow descriptive studies to examine the effectiveness of these changes and to help States modify policies and approaches.

The effects of interaction and coordination between and among TANF, child development, child welfare, child support, and communitywide interventions constitute another key element of ACF's evaluation agenda. The economic security and overall well-being of disadvantaged children and families may be improved not only by how States design their TANF programs but, more likely, by how States integrate public assistance systems with programs and resources to address child development, family stability, child welfare, and parenting development. Efforts to create a complete picture of public assistance and family and child well-being outcomes will include mechanisms to collect accurate data from States. ACF will work with the Census Bureau and other organizations to ensure that national surveys address issues of concern and will work with States to improve quality and linkages of administrative data.

This evaluation agenda--describing State systems changes, assessing impacts on affected populations, and monitoring State and local program interaction--can only be realized through partnerships with State and local governments, professional organizations, service providers, and others in both the public and private sectors.

Administration on Aging

MISSION: To foster the development of services to help older persons maintain their independence.

Evaluation Program

The Administration on Aging (AoA) is the Federal focal point and advocate agency for older persons and their concerns. The AoA administers key Federal programs mandated under various titles of the Older Americans Act. These programs help vulnerable older persons to remain in their own homes by providing supportive services. Other programs offer opportunities for older Americans to enhance their health and to be active contributors to their families, communities, and the Nation through employment and volunteer programs. AoA works closely with its nationwide network of regional offices and State and Area Agencies on Aging to plan, coordinate, and develop community-level systems of services that meet the unique needs of individual older persons and their caregivers. The AoA collaborates with Federal agencies, national organizations, and representatives of business to ensure that, whenever possible, their programs and resources are targeted to the elderly and coordinated with those of the network on aging.

As the responsibilities of this nationwide network of State and Area Agencies on Aging continues to grow, it is essential that they have the necessary information to meet these responsibilities.

The overall evaluation priorities of AoA are to support studies that provide information on the following:

Summary of Fiscal Year 1996 Evaluations

One evaluation was completed in FY 1996, the evaluation of the Elderly Nutrition Program (ENP) under TitleIII and TitleVI of the Older Americans Act. This evaluation is highlighted in chapter II and is summarized below. The results of the evaluation show that the ENP has succeeded in accomplishing its mission of improving the nutritional intakes of elderly people, as well as in decreasing their social isolation. The evaluation also shows that the program is evolving to meet the changing needs of older people brought on by shifting demographics and changes in the health care system. There are indications of unmet needs for the program's services, as well as signs that there may be new roles for the program in the future.

The ENP provides an average of one million meals per day to older Americans. These meals are targeted toward highly vulnerable elderly populations, including the very old, people living alone, people below or near the poverty line, minority populations, and individuals with significant health conditions or physical or mental impairments. On average, the meals provided easily meet the recommended daily allowance requirements and significantly increase the dietary intakes of ENP participants. The ENP also reduces the social isolation of older Americans in both the congregate and home-delivered programs and links participants with other needed services. Agencies at all levels have forged close links with other parts of America's emerging home and community-based long-term care system. Federal dollars are highly leveraged. Despite participant's low income levels, their contributions account for 20percent of both congregate and home-delivered meal costs. Local donations and volunteer time, often from program participants, account for 14 percent of costs.

Evaluations in Progress

Evaluation is an important part of the AoA program, and a number of evaluation activities are currently under way, although not on a national level. Many State and Area Agencies on Aging are conducting evaluations of their Older Americans Act service programs. These studies generally focus on such issues as the needs of the target population, the quantity and quality of services delivered, and the impact of the services on the older person. Results are used to better design and target Older Americans Act services. Regional offices of the AoA also conduct assessments of the needs of the States for training and technical assistance. Finally, demonstration projects funded by the AoA have evaluation components to enable them to assess their progress in meeting the objectives of their demonstrations.

New Directions for Evaluation

Given the evolving roles of AoA and State and Area Agencies on Aging and the continued (and projected) growth of the Nation's elderly population, AoA's evaluation efforts will continue to focus on effective program planning and service delivery, as well as on continued monitoring of the program's effectiveness in addressing the goals of the Older Americans Act.

The changes occurring in the aging service-delivery network present an opportunity to learn critical lessons in program planning and system development. These changes include more systematic focus on home- and community-based long-term care, growing sophistication in addressing a variety of needs of the older population, the growth of managed care, and the implementation of sophisticated program information systems. Future evaluations will need to consider the impact of these and similar developments on the delivery of Older Americans Act services to our Nation's older persons.

Agency for Health Care Policy and Research

MISSION: To generate and disseminate information that improves the health care system.

Evaluation Program

The Evaluation Program within the Agency for Health Care Policy and Research (AHCPR) is designed to respond to three types of evaluation needs:

To address these needs, evaluation components are built into virtually all AHCPR activities. Among the evaluation mechanisms used by the agency are targeted evaluation studies undertaken through contracts or grants; peer review of grant applications and technical review of contract proposals for scientific rigor and integrity; efforts to obtain feedback from "customers" on the usefulness of AHCPR research efforts; feedback from AHCPR's User Liaison Program (which provides information and technical assistance to State policymakers, health departments, and officials); and other targeted efforts, such as focus groups and surveys to provide baseline information, inform the design of future agency work, and assess progress toward goals.

AHCPR received delegated authority to review evaluation projects in 1992. In carrying out that authority, it established a two-tier system for assessing proposed evaluation projects eligible for 1-percent set-aside funds. The first phase of the process, an executive-level review assessing the policy relevance and relative priority of proposed projects, is conducted by the administrator and senior staff. The second, a technical merit review, assesses policy-relevant proposals for technical feasibility, soundness of design, costs, potential importance of the findings, and relation to ongoing evaluation activities. This second review is conducted by the Task Force on AHCPR Evaluation Projects, a group consisting of one individual with evaluation expertise from each Office and Center in the agency.

Summary of Fiscal Year 1996 Evaluations

The four high-priority evaluation projects completed in FY 1996 directly reflect the agency's commitment to enhancing the scientific underpinnings of the Nation's efforts to measure and improve the quality of health care services. Each provides information to enhance the quality of the health care system: information that can improve clinical quality, inform consumer choice, and focus future research on what works best in health care.

Evaluating Practice Guidelines and Developing Science-Based Measures of Clinical Quality

The first of the four completed projects assessed the feasibility of deriving clinical quality evaluation and improvement tools from evidence-based practice guidelines. The project responds to the country's increasing demand for valid, reliable, science-based indicators of clinical quality that can be used in a variety of health care settings. A contract with the Center for Clinical Quality Evaluation (formerly the American Medical Review Research Center) in Washington, DC, translates three practice guidelines (for urinary incontinence, acute postoperative pain, and benign prostatic hyperplasia) into performance measures that can be used to determine the extent to which clinical care is consistent with scientific recommendations and to target specific opportunities for quality improvement.

With the assistance of Medicare Peer Review Organizations (PRO's) from four States, the project developed guideline-based measures and tested them for use among the Medicare population. The PRO's also served as educational facilitators in a quasi-experimental design component of the project focusing on the introduction of the benign prostatic hyperplasia (BPH) guideline in four "continuum-of-care" settings (clinics and provider groups providing both ambulatory and inpatient care).

The project found that it is feasible to develop guideline-based performance measures that could be used to evaluate and improve clinical performance. The BPH guideline was favorably received by both physicians and patients, and improvements in clinical performance made for specific areas were the focus of educational interventions.

Enhancing the Science of Clinical Quality Measurement

The second project, the Computerized Needs-Oriented Quality Measurement Evaluation System (CONQUEST 1.0), enhances the science of clinical quality measurement and evaluation by creating a standardized and rigorous approach to understanding performance measures, as well as for identifying, evaluating, and selecting measures most appropriate to the users' needs. The project collected 53 sets of clinical performance measures (tools that assess the delivery of clinical services) and summarized their content and construction so that the measures could be compared directly on factors such as their data needs, the aspect of clinical care each measure evaluates, their scoring and analysis considerations, reliability and validity testing, and the extent of their use to date. The information collected is summarized in a "measure" data base.

In addition to information on clinical performance measures, the project summarizes information on 50 common clinical conditions into a "condition" data base. Information in the condition data base includes age groups affected by the condition; forms and prevalence of the condition; cost and utilization associated with the condition; comorbidities, risk factors, and potentially preventable adverse events associated with the condition; information on clinical services used to diagnose and treat the condition; and information on provider settings and health care professionals associated with the primary condition. A key feature of the condition data base is its inclusion of recommendations from clinical practice guidelines and findings from medical effectiveness research. Information from the condition data base can be used to identify performance measures for a given condition, facilitate the use of individual performance measures for broader quality measurement and improvement uses, and interpret findings from performance data relative to information from practice guidelines and medical effectiveness research.

Initial response to CONQUEST 1.0 has been extremely favorable; the agency has distributed over 3,000 copies of the first version of the software and user manual and is currently developing a "run time" version that will function in Windows 95. In addition, the agency is building on this initial effort by sponsoring a multiyear contract to develop a Quality Measurement Network, a clearinghouse and technical resource for those interested in identifying and using measures to evaluate and improve clinical performance.

Helping Consumers Understand Health Care Quality Information and Evaluate Health Care Plans

The third project, described in chapter II, develops an approach for States to use in evaluating the effect of health care delivery changes on access to, quality of, and satisfaction with health care. Through the AHCPR Rural Health Research Center at the University of Washington, and its subcontractor the Oregon Health Sciences University, the Oregon Consumer Scorecard (OCS) Project assists the State of Oregon in developing an approach to evaluate access to and quality of care provided under the Oregon Health Plan. The Oregon Health Plan is a State-supported health insurance program designed to provide universal access to care for low-income residents. The project assisted in the development and pilot testing of measures of clinical quality and consumer satisfaction and assessed methods for communicating quality information to consumers in a way that would help them evaluate and select health care plans.

The project found that the information needs of consumers and health professionals differ markedly. While consumers judge health plans on such issues as how they gain access to specialty services for various acute or chronic conditions, health care professionals use population-based performance measures to judge quality of care. These population-based measures focus more extensively on clinical processes and outcomes; while these measures currently may have little meaning to most consumers, they have great potential in shaping the quality of health care and health plan accountability. The project found that consumers are interested in a variety of formats for reviewing health plan data and that the availability of a "personal guide" or a trained individual to assist consumers in understanding information would be highly beneficial. With respect to health plan information needs, the project found that health plans face a "data burden" that is costly and could be relieved by the establishment of uniform standards that are used by all health plans and purchasers.

In addition to providing technical and substantive assistance to the State of Oregon, the project develops the science base for statewide quality assessment and reporting, an effort which can be used to help other States evaluate quality of care.

Synthesizing Information From AHCPR-Sponsored Research

The last of the four projects is a multiyear effort to track and synthesize findings from AHCPR-sponsored research in the Medical Treatment Effectiveness Program (MEDTEP). AHCPR has been working with Walcoff and Associates, Inc., of Fairfax, Virginia, to collect and analyze information on MEDTEP research, including clinical practice guidelines. The project has collected information from published professional literature; presentations to and proceedings of conferences and meetings; trade journals in the health care delivery field; reports of congressional testimony and deliberation; reports of State and local legislation or executive testimony and deliberation; magazine and newspaper articles; radio and television programs; and reports of other Federal agencies. During the period of the project, findings from these tracking efforts have been published in the AHCPR-sponsored newsletters Research Activities and MEDTEP Update. Most recently the project has produced comprehensive summaries of MEDTEP projects, a bibliography of Publications of the Patient Outcomes Research Teams projects, and a data base of information on these AHCPR-sponsored projects.

Evaluations in Progress

Ongoing evaluations at AHCPR focus on three broad areas: environmental scans to identify research needs and potential partnership opportunities, evaluations of ongoing agency work, and evaluation planning and design studies to guide future efforts. These activities are part of AHCPR's emphasis on developing and implementing measures of agency performance and on ensuring that agency-sponsored research efforts are most useful to a wide range of audiences.

Assessing the Health Care Environment

Three projects examine ongoing health care policy and research activities in the public and private sectors. These "environmental scans" help AHCPR identify emerging health policy and research issues, facilitate agency strategic planning, and avoid duplication and waste of resources. They also identify areas in which Federal resources, tools, data, and methodologies can help answer questions about the effects of health care policy changes on the cost, quality, and access to health care services, as well as the effectiveness of those services.

One project builds on the work of the Department of Health and Human Services Data Council's Committee on Health Data Standards and the Information Infrastructure Task Force's Health Information Working Group to collect and summarize information on the information standards activities of various Federal agencies. This project will update a previous report, Current Activities of Selected Health Care Informatics Organizations. Another project will identify and describe the range of outcomes research activities conducted by various private-sector organizations and focus on approaches for identifying research topics, outcomes research methodologies, and translation of findings into clinical practice. A third project in this group will identify approaches to achieving productive public-private research collaborations. This effort will use publicly available data to identify examples of public-private collaborations and to examine such facets of the project as methods for identifying research topics, treatment of investment and financial records, and reporting research results.

Evaluating Ongoing Agency Work

Three projects in the agency's current portfolio evaluate aspects of AHCPR's ongoing research program activities. The first is a readership survey assessing customer satisfaction with selected AHCPR publications. The study focuses on the AHCPR publication with largest distribution, Research Activities, and will assess both the format and content of the publication. Subsequent surveys will target other agency products, with the objective of developing more effective means of communicating agency research findings. Another project synthesizes the results of AHCPR research aimed at implementing and evaluating of clinical practice guidelines, physician behavior change strategies, and other quality improvement tools. The third project in this category evaluates AHCPR's training activities for minority health services researchers. It will also examine other (non-AHCPR) minority health services research efforts to identify desirable elements and characteristics of success.

Evaluation Designs and Planning Studies

Four projects are ongoing in the area of evaluation design and planning. These projects assess the current state of knowledge on a given health care topic area, identify research gaps, and develop and test approaches and indicators that could be useful for assessing the quality of agency-sponsored programs. The first project, an assessment of data release strategies, examines how data from AHCPR's Medical Expenditure Panel Survey and other national data bases have been used to support health policy and health services research. The project will delineate the strengths and weaknesses of the various data sets and identify ways to increase their utility. It will also provide needs assessment information essential for maximizing the usefulness of AHCPR's large-scale data efforts.

Another project examines the feasibility of compiling an encounter-level managed-care research data base by identifying currently available public- and private-sector data and by identifying data analysis and data release problems. The third project in this category focuses on better understanding research needs in the area of appropriateness of care. This study will explore the published literature on the causes of diagnostic inefficiency in primary care, interventions designed to address these inefficiencies, and the effect of interventions on the quality of care. The project will focus on errors in selected high-cost, high-prevalence areas of health care for which there may be considerable uncertainty about diagnosis, but accepted treatments. The final study in this category examines published and unpublished studies on the effects of consumer health informatics on patient decision making.

New Directions for Evaluation

In FY 1998 and beyond, AHCPR will focus its evaluation activities in three general areas: the development and use of agencywide performance measures, evaluation projects targeted at effective communication and implementation of health care quality and effectiveness findings, and evaluation of the effect of health care policy changes on the cost and quality of services, access to services, and the effectiveness of those services.

The first area emphasizes agencywide performance measures that can evaluate the quality of the agency's work and inform policy making, budget planning, and program management. Agencywide performance measures will help AHCPR address requirements of the Government Performance and Results Act, providing information that will improve the agency's performance in key program areas. Projects initiated in FY 1997 will produce and test measures that can be applied in FY 1998 and beyond. In addition to these efforts, the agency will be evaluating the effect of changes in programmatic operations. One example of this type of effort is a proposed evaluation of the effect of recent improvements to the AHCPR grants process.

The second area centers on building AHCPR's portfolio of research to translate research findings into forms of information that actively assist consumers, practitioners, payers, and others in making effective health care decisions. Of particular interest to the agency are needs assessment and formative evaluation efforts related to the new Evidence-Based Practice Centers program. This new initiative, which will replace AHCPR's guideline development program, creates research centers that will conduct systematic reviews and synthesize scientific evidence related to the effectiveness of various approaches, procedures, and technologies. These evidence syntheses can be used by practitioners and health care organizations to develop clinical practice guidelines and other quality improvement tools. Evaluation activities will first focus on assessing user needs in terms of topics, formats, and technical assistance. Subsequent evaluation activities will assess the usefulness of the new products for clinical quality improvement.

The third area will build on AHCPR's work to examine and evaluate changes in the health care system and how those changes affect access to care, use of services, quality of care, and patient outcomes. As the agency continues improving the Medical Expenditure Panel Survey, new evaluation questions and opportunities arise on such issues as the efficiency of the new design and its effectiveness in answering key health policy questions. The agency will be evaluating aspects of the survey process, including data support contracts and approaches to evaluating modeling capacities.

Centers for Disease Control and Prevention

MISSION: To promote health and quality of life by preventing and controlling disease, injury, and disability.

Agency for Toxic Substances and Disease Registry

MISSION: To prevent exposure and adverse human health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of pollution in the environment.

CDC Evaluation Program

The Centers for Disease Control and Prevention (CDC) places high priority on evaluations seeking to answer policy, program, and strategic planning questions. Performance improvement studies are of particular interest and importance to the agency. Evaluation studies are developed and selected based on CDC's eight strategies to achieve its mission:

CDC's evaluation philosophy is consistent with its overall focus on the practice and application of sound public health strategies. This orientation is exemplified by the agency's "bottom up" nature of project development. Projects are conceptualized, developed, and monitored by the public health professionals at CDC who are most closely aligned with the everyday practice of public health--program staff.

On an annual basis, the Director of CDC provides guidance to the various Center, Institute, and Office Directors on 1-percent set-aside evaluation activities. This memorandum generally includes information about the types of studies to be carried out with 1-percent evaluation funds. Each proposal undergoes multiple levels of review. Initial review is conducted by the Office of Program Planning and Evaluation. Subsequent reviews are completed by staff within the Office of the Assistant Secretary for Planning and Evaluation. Study authors are provided with comments, questions, and recommendations made by reviewers. In addition to providing their responses, authors are given the opportunity to revise their proposals at this time.

A panel of CDC evaluators, scientists, and program managers meets to review and rank proposals. Review criteria include (1) relevance to prevention effectiveness; (2) relative importance of the public health problem being addressed; (3) probability that the proposed project will accomplish its objectives; and (4) the extent to which other CDC programs will derive benefit from the project. Results from this panel review are converted into a comprehensive ranking, which is provided to the Director of CDC. Final funding decisions are made at this time.

Finally, staff within the Office of Program Planning and Evaluation work closely with program staff to ensure development of a clear statement of work for selected projects. Prior to initiation of procurements, a final ad hoc review of the project statement of work is completed.

ATSDR Evaluation Program

The Agency for Toxic Substances and Disease Registry (ATSDR) receives its funds from Environmental Protection Agency Superfund appropriations, rather than from public health appropriations; therefore, ATSDR does not receive a 1-percent evaluation set-aside. Nevertheless, ATSDR is responding to the changes mandated in its program planning and evaluation efforts by the National Performance Review and the Government Performance and Results Act. To meet those requirements, ATSDR staff members modify the agency's planning process, incorporating implementation strategies and outcome performance measures.

Prominent issues addressed in the new planning system emphasize ATSDR's priority of improving the health of people affected by hazardous substances polluting the environment. Using exposure assessments and demographic data to identify people at risk and, more directly, assessing and addressing the concerns of ATSDR customers represent some of the improvements. The new planning system provides the basis for measuring ATSDR performance and making systematic improvements as part of its internal evaluation activities.

Summary of Fiscal Year 1996 CDC Evaluations

A total of 17 evaluation projects were completed in FY 1996, 6 of which are reported in appendix A. Ten of these projects were funded through the 1-percent evaluation set-aside, and 7 were funded with program dollars. These studies are of four types: data policy and surveillance studies, program evaluations, evaluations of educational interventions, and assessments of specialized aspects of current or proposed programs.

Data Policy and Surveillance Studies

Three studies sought to assess the implications of policy decisions on various existing or proposed data and surveillance systems. One of these projects was part of an effort to develop a comprehensive monitoring system to track the impact of health reform and provide feedback to policymakers. Although such a system was expected to monitor the impact of the 1994 Health Security Act, the report suggests that a system could be designed to inform health policy, regardless of the ultimate shape and timing of health reform. A second study was undertaken to assist in developing an appropriate accountability system for the Vaccine for Children (VFC) program that is both rigorous and practical for use in clinical settings. As part of this study, data collection procedures for proposed systems were tested to determine their practicality and usefulness for collecting vaccine usage data. The study also provided information about the acceptability of any accountability system to health care providers, since a system that is perceived as overly burdensome could discourage participation in the VFC program. Another study evaluated whether and to what extent use of CDC WONDER/PC by State and local public health practitioners positively affects the practice of public health, along a variety of dimensions (e.g., efficiency, scope, quality, and timeliness of work).

Program Evaluations

Four program evaluation studies were completed in FY 1996. These studies included evaluations of CDC's Prevention Effectiveness Activity, the National Center for Injury Prevention and Control's injury grant program, and the National Nosocomial Infections Surveillance Program. In addition, a case study of the Henry J. Kaiser Family Foundation's Community Health Promotion Program was completed.

Evaluations of Educational Interventions

Three of the four evaluations of educational interventions completed in FY 1996 focused on provider educational issues. One of these projects addressed health care providers' use and perceptions about vaccine package inserts, in an effort to improve the utility of inserts in communicating the nature and extent of dangers imposed by vaccines. A second immunization educational intervention developed and field tested a quality assurance tool designed to facilitate provider self-assessment, emphasize the importance of following prevention guidelines, and collect data about provider practices. A third study of this type assessed the effectiveness of the domestic violence module of an innovative physician training program that is being implemented at the University of California-Los Angeles Medical School. The final education-related evaluation study examined a variety of questions related to the distribution, awareness, use, and perceptions of the Chronic Disease Prevention (CDP) File. The CDP File consists of the Health Promotion and Education Database, the Comprehensive School Health Database, the Cancer Prevention and Control Database, and the Chronic Disease Prevention Directory.

Assessments of Specialized Aspects of Current or Proposed Programs

Five studies relating to discrete aspects of current or proposed programs were completed in FY 1996. Two of these projects were developmental and resulted in training materials. One activity concluded with the provision of an evaluation training course and materials for CDC Planning and Evaluation Officers. The other project identified key factors in the successful development and implementation of CDC-funded youth violence prevention projects and compiled the findings into a document to help individuals, groups, or communities implement youth violence prevention and intervention projects. Another study examined the impact of mandated managed care on health care. Based on eight case study organizations, this evaluation found (1) little prevention activity; (2) no relationship, or a poor one, with the local health department in half of the organizations; and (3) a dispersion of activities among community organizations that challenges the traditional roles of State and local health departments.

The two final studies of this type were related to immunization. One examined issues surrounding consent for adolescent immunization. As adolescent vaccination expands, particularly hepatitis B vaccination, issues related to need for parental consent for receipt of indicated vaccines become increasingly important. Similarly, operational issues surrounding the provision of immunization services is critically important. The final study evaluated how audits conducted in the State of Georgia from 1986 to 1994 affected immunization coverage levels in the preschool population and determined medical and management policies and practices that influence immunization rates.

CDC Evaluations in Progress

CDC's evaluation studies, in progress during FY 1996, consisted of four types: evaluations of data policy and surveillance studies; program evaluations; development of performance measures; and assessments of specialized aspects of proposed or existing programs.

Evaluations of Data Policy and Surveillance Systems

Ten studies are under way that relate to data management or reporting systems. These studies include evaluations of the use of data transmitted through CDC's National Electronic Telecommunications System for Surveillance (NETSS) and the Public Health Laboratory Information System (PHLIS), as well as an assessment of the National Immunization Survey (NIS). Evaluations of specific issues critical to data quality are also under way. These studies include evaluations of racial and ethnic identification data, redesign of the National Health Interview Survey (NHIS), and an examination of the effectiveness of CDC surveillance for drug-resistant pneumococcal infections.

In the case of the study of NETSS and PHLIS, determinations about how surveillance data transmitted through each of these systems are used at local, State, and Federal levels will be made. Similarly, the centerpiece of the NIS study is to design an evaluation system that will focus on three main questions: How well does the NIS meet the program needs of the National Immunization Program for estimates of immunization coverage rates for population groups of special interest? Is there a way to simplify the analytic methods currently used on the survey without jeopardizing the statistical integrity of the survey? Is there a way to make the survey data collection less costly without jeopardizing the statistical integrity of the survey?

Both the evaluation of racial and ethnic identification data and the redesign of the NHIS represent efforts to understand and refine survey operational issues. Finally, the study evaluating CDC's current surveillance system for drug-resistant Streptococcus pneumoniae will evaluate this system's hospital-based sentinel surveillance system for sensitivity and representativeness. Active population-based surveillance for invasive pneumococcal infections in two geographically distinct areas will be conducted. Surveillance areas for this evaluation are either adjacent to a sentinel surveillance hospital or in a community with one or more hospitals sufficiently large to serve as a comparison for the rest of the community.

Program Evaluations

Eight program evaluations are currently in progress. Included in this number are evaluations of the National Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluation Program, the Field Epidemiology Training Program, the National Laboratory and Training Network, and the Prevention Centers Program.

The study of the Health Hazard Evaluation (HHE) Program is a process evaluation. As such, the overall purpose of the study is to develop a tool and procedure by which the NIOSH can conduct an ongoing evaluation of the effectiveness of the HHE Program, which responds to 400 to 500 requests for on-site health hazard evaluations each year from employers, employees, employee representatives, or other Federal, State, or local agencies.

By contrast, two of the other studies mentioned are outcome evaluations. The evaluation of the Field Epidemiology Training Program (FETP) will ascertain whether the program has achieved its objectives, which are to train public health professionals in applied epidemiologic skills, to promote the sustainability of autonomous FETP's, and to develop a global network of national programs.

The evaluation of the National Laboratory Training Network (NLTN) will assess the degree to which the NLTN achieves its goals and mission. Study questions fall into five general categories: offerings related to needs of laboratories and their staff; quality of the training provided; impact of the training provided; quality of outreach and marketing; and barriers to training.

Finally, the evaluation of the Prevention Centers Program will assess to what extent CDC-supported research is providing the public health community with workable strategies to address major public health problems. Prevention research issues related to innovation, relevancy, dissemination, application, and quality of research are the focus of this project.

Development of Performance Measures

Four ongoing projects involve the development of performance measurement systems. Two of these studies relate directly to the Government Performance and Results Act of 1993 (GPRA). A third study will develop indicators by which the fiscal and programmatic impact of HIV-prevention community planning may be measured. The final study of this type entails the development of an evaluation protocol for State-based diabetes control cooperative agreement programs.

Assessments of Specialized Aspects of Proposed or Existing Programs

Fourteen specialized studies relating to discrete aspects of current or proposed programs are in progress. These studies include an evaluation of tuberculosis (TB) Outreach Worker Activities, as well as a community context study seeking to understand minors' access to tobacco products. Two studies related to violence prevention are also included in this category. One of these studies relates to suicide in Native American communities, and the other considers various implementation aspects of youth violence-prevention programs.

Each of the studies mentioned has at its core a desire to understand particular human behaviors and motivations. A clear understanding of these issues must be present before wholehearted program and fiscal commitments are made. For example, the Advisory Committee for the Elimination of TB recommended increased funding for TB outreach and workers conducting the outreach. However, prior to committing resources to this strategy, it is incumbent upon CDC to have a clear understanding of how outreach work is currently conducted and what outreach workers do in their everyday work. It is through the evaluation of TB Outreach Workers that the National Center for HIV, Sexually Transmitted Disease, and TB Prevention will be provided with baseline data about how outreach workers function.

Similarly, a community context study is also being conducted that will refine CDC's understanding of the relationships between public policies prohibiting minors' access to tobacco, implementation and enforcement of such policies, tobacco vendor perceptions, actions that may influence the sale of tobacco products to minors and the use of tobacco products by minors.

Finally, two evaluations addressing violence-prevention issues are also under way. The first of these studies is being conducted jointly by CDC and the Indian Health Service. This study will evaluate surveillance systems, process indicators, and outcomes of four multifaceted suicide-prevention programs. The focus of the second violence-prevention study involves evaluating the effectiveness of a selected program for health care providers and battered womens' advocates. Specifically, the ability of this program to successfully diagnose, manage, refer, and otherwise assist female victims of intimate partner violence will be assessed.

New Directions for CDC Evaluation

CDC's evaluation program will continue to support studies aimed at improving public health programs. This focus on improvement is consistent with the congressional intent of GPRA. Efforts to develop and implement performance indicators are currently under way at CDC. Similarly, as programs have been developing and implementing performance indicators, projects that assess the effectiveness and efficacy of such indicators have been initiated.

CDC's evaluation priorities in upcoming years will be based on five cross-cutting strategies that address the programmatic needs of its 11 Centers, Institutes, and Offices.

Strengthen Core Public Health Functions

A number of key activities at CDC center around the agency's commitment to strengthening the Nation's core public health functions. Tangible results of this commitment are reflected by CDC's work with State and local health departments and other partners throughout the country to obtain the information necessary for monitoring and evaluating health, conducting epidemiologic and laboratory studies, developing new technologies, and providing training and technical assistance to ensure that States and communities can protect the health of their citizens. Ongoing and proposed evaluation studies seek to answer how well CDC is fulfilling this commitment.

Enrich Our Capacity to Respond to Urgent Threats to Health

Epidemiologic investigations and laboratory work done by CDC and State and local health departments enable CDC to address urgent threats to public health in a timely and effective manner. Similarly, in a world increasingly threatened by emerging infections, CDC's leadership role in this area is critical. A number of studies are under way that address emerging infections, including Group B Streptococcus, perinatal HIV, and drug-resistant pneumococcal infections.

Develop Nationwide Prevention Strategies

One of CDC's key roles is to translate knowledge about effective methods of preventing disease and injuries into nationwide strategies that reach people in communities throughout the country. Several studies under way seek to assess the extent to which guidelines developed by CDC affect disease prevention activities throughout the Nation.

Promote Women's Health

Recognizing that women's health issues have not always received the attention they have warranted, CDC has identified promotion of women's health as one of its top priorities. Although a number of projects are funded by CDC's Office on Women's Health, there are several ongoing evaluation studies that address important women's health issues. One such study is an evaluation of guidelines for preventing perinatal HIV infection by measuring how recommendations are translated into routine clinical practice. Successful implementation of recommendations depend on the ability to maximize the opportunities for HIV-infected women to learn their HIV infection status, to be offered and receive preventive therapy, and to gain access to health and social services for themselves and their infants.

Invest in Our Nation's Youth

CDC's commitment to investing in the youth of our Nation is exemplified by school health education programs. However, CDC's investment is not limited to school-based intervention programs. For example, one study is designed to assess the effectiveness of various teen pregnancy prevention interventions. This study will result in a systematic methodology to identify and evaluate community intervention components that show promise based on behavioral science theory, available evaluation information, and the consensus of leaders in the field.

Food and Drug Administration

MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.

Evaluation Program

Systemic changes in the government management environment are strongly influencing the setting, conduct, and utilization of evaluation activities in the Food and Drug Administration (FDA). Two forces related to the goals of the Government Performance and Results Acts (GPRA) are driving and reshaping the evaluation function within the FDA.

Performance Management

The reorientation of all government managers toward performance management has shifted the responsibility for program evaluation from specialized staff offices and contractor studies to the line managers. Picking appropriate program goals, establishing a valid measure of these goals, and collecting management information to record the measured progress toward these goals are now an integral part of the manager's responsibility. Relearning the role of management with regard to these shifted responsibilities is a key priority.

Customer Participation

Most of the FDA's management measures of its own performance are also measures of the performance of the regulated industries. Thus, while the beneficiary of FDA's performance is ultimately the general public, the FDA supplies industry with an essential component of commercial success. The FDA's approval of a new drug, for example, not only satisfies a legal requirement but also assures the public of the safety and efficacy of the drug. Collaboration between the FDA and its regulated customers regarding the design and coordination of the joint responsibilities to ensure effective high-quality products has been a revolutionary concept, but it is becoming the new norm under the customer-conscious GPRA directives.

An extension of both performance-based goals and customer participation also affects our response to small businesses.

Responding to the Needs of Small Business

A high proportion of industries regulated by the FDA are small businesses. In order to improve responsiveness to industry needs without compromising the protection of the public health, the FDA is emphasizing two strategies. One is to enhance industry input during the rulemaking process and to increase the rigor of analysis of possible regulatory strategies. The second is to improve compliance, where possible, through better education and remedial technical assistance. Both strategies extend the existing priority of customer participation and performance-based goals to focus on enhancing the participation and performance of small businesses.

In sum, the FDA's evaluation efforts are driven by the mandates of GPRA and its corollaries, are carried out by line managers rather than specialized evaluation staffs, and are focused in the areas of performance management and customer participation, with additional attention to the needs of small businesses. Because the FDA receives its funds from agriculture appropriations rather than Public Health Service Act appropriations, the FDA does not manage a 1-percent evaluation set-aside.

Summary of Fiscal Year 1996 Evaluations

FY 1996 marked the third year under the new evaluation paradigm. The following example illustrates the manner in which managers have integrated evaluation into their line responsibilities and conducted evaluation in cooperation with the affected customer.

Implementation of the Prescription Drug User Fee Act

FY 1996 marked the fourth year of the 5-year implementation of the Prescription Drug User Fee Act (PDUFA) of 1992, which authorized the collection of fees from the pharmaceutical industry in order to facilitate the FDA's timely review of human drug applications. The act mandates that the FDA prepare annual reports for each fiscal year in which fees are collected. The Fourth Annual Performance Report (covering FY 1996) was prepared in response to that mandate and summarizes findings on how well the FDA has accomplished its performance goals for FY 1996. These performance-related goals were jointly established between the FDA and the pharmaceutical industry and fall into three main categories: eliminating overdue backlogs, building excellence into the review process, and achieving high performance. Eighteen of the goals have already been accomplished and reported in previous years' performance reports. Four additional goals were in effect for FY1996, while seven more will be in effect for FY 1997.

The success of the fourth year of PDUFA is reported in the Fourth Annual Performance Report. Despite an increasing workload, the agency has exceeded every PDUFA performance goal, resulting in a record number of new product approvals and shorter approval times. Under PDUFA, during FY 1996, the FDA approved 131 new drug applications and product license applications, an increase of 56 percent over FY 1995's total (84) and a 96-percent increase over FY 1994's total (67). PDUFA has enhanced the working relationship between the FDA and its sponsors, resulting in higher quality applications that can be accepted immediately and reviewed more quickly. Ultimately, new products are reaching the market faster.

Consumer Use of Food Labels

The Nutrition and Labeling and Education Act (NLEA), passed by Congress in November 1990, led to the most far-reaching changes in food labeling since the Food, Drug, and Cosmetic Act of 1934. The new regulations, governing the content and format of food labels on nearly all FDA-regulated products, went into effect in 1994. The NLEA had multiple objectives that will have multiple short- and long-term impacts on consumers and the marketplace. To monitor some of these impacts, the FDA is tracking consumer awareness, attitudes, and reported behaviors through nationally representative sample consumer surveys, is examining changes in the marketplace by looking at sales trends for selected product categories, and is assessing compliance with NLEA regulations. Some preliminary findings are presented in The Impact of the NLEA on Consumers: Recent Findings From FDA's Food Label and Nutrition Tracking System, which was completed during FY 1996. This report offers some insights into the impact of the new food label regulations that occurred in the period shortly after the regulations were implemented:

For a small number of product categories in which fat-modified products are available, there has been an impressive, simultaneous increase in new product introductions and percentage of market share for these fat-modified products. While each product category has a unique history, these data mirror recent news reports that suggest both consumers and food manufacturers have responded to the impact of the nutrition facts label on food products. These preliminary market trend analyses are consistent with the views that increased availability of nutrition information, as mandated by the NLEA regulations, has contributed to a growing number of new fat-modified products in the marketplace and that these products are garnering an increasing share of their respective markets.

Food Labeling and Package Survey

The report, Status of Nutrition Labeling of Processed Foods--1995, completed in FY 1996, reviews the status of processed, packaged food labels subsequent to publication of regulations promulgated in response to the NLEA of 1990. The findings were based on data from the Food Label and Package Survey (FLAPS), started in 1977. The purpose of FLAPS is to produce a data base containing label and package information obtained from a sample of food products from the processed packaged food industry. The primary information gathered consists of the prevalence of nutrition and sodium labeling. Label and package information are obtained from the food labels of approximately 1,300 brands of food. The sampling frame for FLAPS is based on sales data obtained from the A.C. Nielson Company, from which sales-weighted estimates are subsequently derived. The major findings from this review include the following:

The current study focuses only on the percentage of packaged food products sold annually that bear quantitative nutrition labeling, as well as data on health claims, nutrient content claims, and ingredients.

Evaluations in Progress

The evaluation agenda of managers during FY 1997 and in the future will be influenced by two objectives, performance management and customer participation, which reflect the forces shaping their evaluation role. Managers of all FDA programs are engaged in the process of evaluating their performance measures in light of the GPRA standards. Broad-based training of managers to enable them to implement the performance design of their responsibilities is under way. This multiyear process toward a new standard of performance measure will end its first phase with the formulation of the FDA's FY 1997 budget. FDA managers are also identifying further opportunities to involve their customers in the design and testing of alternative ways of doing business. The design and implementation of the PDUFA is the notable example of the successful pursuit of this objective. FY 1997 will mark the fifth annual performance evaluation report on this successful program.

The following projects are currently under way.

Implementation of the Prescription Drug User Fee Act

FY 1997 marks the fifth year of the PDUFA program. Seven goals have been established, delineating the most ambitious standards of this program. The effects of additional resources were evident in the FY 1996 program where, despite an increasing workload, the agency exceeded every performance goal, resulting in a record number of new product approvals and shorter approval times. There is also evidence that the quality of applications has improved. Based on last year's performance, it is anticipated that the FY 1997 phase of this program will not only meet the established goals, but substantially exceed those goals.

Assessment of the Mammography Quality Standards Act of 1992 (MQSA)

This program is the FDA's second major user fee, performance-oriented, GPRA-style initiative. Under this statute, the FDA is charged with ensuring that accessibility to quality mammography services is maintained for all facilities performing mammographies. The agency is required to certify and annually inspect more than 10,000 mammography facilities. Prior to passage of the MQSA, the FDA's oversight responsibility was limited to approving new mammographic processors, x-rays, and tubing. However, MQSA requires that facilities within its jurisdiction meet standards developed by the agency in order to ensure that a reasonable level of quality is maintained to achieve certification by the agency.

The FDA is concerned that recent trends by third-party payers to capitate payments for mammography services have severely limited the ability of facilities to absorb any cost increases caused by the quality standards. Studies have indicated that excess capacity exists within the industry. Therefore, more efficient provision of mammography services may result in low-volume facilities leaving the industry. The agency needs to assess these economic implications in order to ensure that patients will continue to have access to affordable, high-quality mammography services. This study addresses these issues in two ways. The first involves measuring the effect of standards on patient access to mammography, particularly in rural areas. Findings for this analysis were reported in the document Effects of Facility Closures on Access to Mammography. The second component is a cost-benefit analysis that will be used to predict the impact of proposed standards on the costs of providing mammography. These issues are addressed using data collected from facilities that provide mammography services. A draft report of the results of the cost-benefit analysis was presented in the spring of 1996, and comments are currently being reviewed. A final version will be available in the fall of 1997. Agency managers are using these results to develop a performance-oriented regulatory policy that will be coordinated with existing customers.

Food Labeling and Package Survey (FLAPS)

This is an ongoing study conducted by the FDA's Center for Food Safety and Applied Nutrition; it will continue through December 1999. In order to monitor labeling practices of domestic food producers, the FDA implemented FLAPS in 1977. The purpose of FLAPS was to produce a data base containing label and package information obtained from a sample of food products from the processed, packaged food industry. The primary information gathered consists of the prevalence of nutrition and sodium labeling. Label and package information is obtained from the food labels of approximately 1,300 brands of food. The sampling frame for FLAPS is based on sales data obtained from the A.C. Nielson Company, from which sales-weighted estimates are subsequently derived. The FDA uses these data to quantify the prevalence of nutrition and sodium labeling in the food supply, the extent of quantitative labeling for cholesterol and fatty acid content, the extent of use of contents product ingredient lists, and the extent and types of nutrition claims appearing on food products. FLAPS data enable FDA personnel to keep abreast of market responses to food labeling rules via changes in product package labels.

FDA Inquiries Assistance Program for Small Business

Under the Small Business Regulatory Enforcement Fairness Act, the FDA must establish a program for answering inquiries and providing assistance to small businesses and other small entities, regarding how to comply with FDA rules. The FDA currently provides assistance and advice to small businesses in a multitude of ways, including Center and regional small business representatives, inspectors, public affairs staff, and others. This project will assess the level of success achieved in coordinating these many sources of advice and usefulness and appropriateness of the assistance. Elements to be evaluated include the frequency, subjects, sources, and recipients of inquiries; the type and timeliness of response; and the number and characteristics of complaints or requests for second opinions. The evaluation will also consider the training and materials available to FDA staff to help them answer inquiries, the barriers to providing timely and useful responses, and issues related to tracking inquiries and responses. The report on this project evaluation is due to be completed by March 1998.

FDA Penalty-Reduction Program for Small Business

The Small Business Regulatory Enforcement Fairness Act requires the FDA to create a program or policy that specifies the circumstances under which the agency may reduce or waive the penalties levied against small business entities for noncompliance. The program must establish the defined circumstances under which alternative penalties can be assessed. This project involves assessing preexisting and revised policies related to monetary penalties and evaluating the scope of the small business penalty-reduction program, the number of enforcement actions against small businesses that qualified (or failed to qualify) for the program, and the total amount of penalty reductions or waivers. The report on this program will be completed by March 1998.

Influenza Virus Vaccines in High-Risk Patient Categories

This study was initiated in FY 1995 and will be ongoing through FY 1998. No reports or publications will be produced from the study. The findings from this project will be used to safeguard public health by investigating the reactogenicity and immunogenicity of influenza virus vaccines. The information derived from this study will also be used to facilitate the scientific review at the FDA's Center for Biologics Evaluation and Research of current influenza virus vaccines used in the United States. Serum samples collected from these studies provide data on antibody responses to the influenza viruses circulating in human populations, indicating whether current vaccines are likely to fail to protect against emerging influenza virus vaccines. This information is critical for making accurate recommendations for the selection of new strains to be used for influenza virus vaccines that are manufactured domestically, guaranteeing the annual availability of serological data to the Public Health Service, data which are unavailable from any other source.

Nationwide Evaluation of X-Ray Trends (NEXT)

Another ongoing domestic evaluation, this survey is sponsored through a cooperative agreement jointly conducted between the FDA and State regulation control agencies. No reports are produced from this study, and this program will continue indefinitely. The study estimates the radiation dosage from diagnostic x-ray examinations, using data collected from previous NEXT surveys of different types of x-ray examinations. Data are available on image quality, photographic processing quality, and types of practice. Public health and professional organizations use this information in setting policy. Some of the products generated in the past have included the National Surveys of Mammographic Facilities conducted during the 1980's and 1990's, a study dealing with poor mammographic quality associated with photographic processing, assessment of skin entrance kerma in the United States, and automatic film-processing analysis of 9 years of data.

New Directions for Evaluation

Changes in government management have created a systemic change in the FDA's evaluation function. The new paradigm--driven by the line manager's performance responsibilities, by the imperatives for involving customers, and by directives for analytically rigorous rulemaking--has replaced the traditional practice of evaluation guided and managed by centralized, specialized evaluation staffs.

Health Care Financing Administration

MISSION: To promote the timely delivery of appropriate, quality health care to the Nation's aged, disabled, and poor through administration of the Medicare and Medicaid programs.

Evaluation Program

The research arm of the Health Care Financing Administration (HCFA), the Office of Research and Demonstrations (ORD), performs and supports research and demonstration projects (through intramural studies, contracts, grants, and waivers) to develop and implement new health care financing policies and to provide information on the impact of HCFA's programs. The scope of ORD's activities embraces all areas of health care: costs, access, quality, service delivery models, and financing approaches. ORD's research responsibilities include evaluations of the ongoing Medicare and Medicaid programs and of demonstration projects testing new health care financing and delivery approaches. These projects address four major themes:

Summary of Fiscal Year 1996 Evaluations

During FY 1996, HCFA completed 10 evaluations:

Evaluation of the Ventilator-Dependent Unit Demonstration looked at the cost of the service for patients who are being weaned from ventilators, which often exceeds the present-day payment system under prospective payment. The project evaluated four demonstration sites that provided care for chronic ventilator-dependent patients. The evaluation comprised three major components: case studies of the demonstration sites, including a comparison of Medicare reimbursement for patient care under the Tax Equity and Fiscal Responsibility Act (TEFRA) compared with reimbursement for the same care under the prospective payment system rules; outcome measures such as comparing the utilization of services, patient health, hospital charges, and Medicare expenditures for individuals admitted to demonstration sites and for patients selected to serve as a control group; and estimation of the effects of implementing a national ventilator-dependent unit program, under TEFRA reimbursement, on utilization and Medicare expenditures.

Evaluation of the Arizona Health Care Cost-Containment System looked at the continuing operation of the Arizona Health Care Cost-Containment System (AHCCCS), with particular emphasis on the implementation and operation of the Arizona Long-Term Care System (ALTCS), a new component of AHCCCS, which began in December1988. AHCCCS is a unique, State-sponsored capitation demonstration that provides public assistance medical care to residents of Arizona who are eligible for Aid to Families with Dependent Children and Supplemental Security Income cash payments. The major research questions included the following:

The results of the quality-of-care analysis indicate that ALTCS nursing home residents are more likely to experience a decubitus ulcer, a fever, or a catheter insertion than nursing home residents covered by NewMexico Medicaid, suggesting a lower quality of care for ALTCS nursing home residents than for those in NewMexico. However, the lack of pre-ALTCS data precluded an analysis of the improvements in quality since ALTCS began. The cost of the ALTCS program during its first 3years was somewhat less than the cost of a traditional program in Arizona (6percent in FY 1990; 13 percent in FY 1991). The AHCCCS acute care program cost also continued to be less costly than of a traditional fee-for-service program.

Assessment of the Impact of Medicaid Drug Rebate Policy on Expenditures, Utilization, and Access used decomposition analysis to determine the change in total drug expenditures before and after implementation of the Medicaid drug rebate program. The role of covered population changes, intensity (utilization rate) changes, changes in efficiency (drug product prices), changes in dispensing fees, changes in rebates, and administrative costs were evaluated. The impact on recipient access was assessed by constructing a person-level file of prescription drug claims, both pre- and post-Omnibus Budget Reconciliation Actof1990 (the legislation that mandated the drug rebate program). During the first two fiscal years the drug rebate amounts accrued were 10.3 percent of the total Medicaid drug expenditures.

Sustainable Support System for Telemedicine Research and Evaluation created an ongoing mechanism by which the cost, effectiveness, and utility of telemedicine services could be systematically evaluated. This was done through formation of a Clinical Telemedicine Cooperative Group, which was modeled after a successful cooperative multicentered research organization. Its functions included (1) providing operational and statistical support for telemedicine research and evaluation; (2) maintaining a communication system to link geographically distant telemedicine projects to share information and perform telemedicine research; (3) creating easily adaptable electronic data collection and tabulation instruments for use in telemedicine research; and (4) building a comprehensive on-line telemedicine information clearinghouse for gathering, storing, and disseminating information about the utility, effectiveness, and suitability of telemedicine for a broad range of medical and social applications.

Evaluation of the Home Health Agency Prospective Payment Demonstration examined the first phase of a program designed to test the effectiveness of using prospective payment methods to reimburse Medicare-certified home health agencies. In this demonstration a per-visit payment method that sets a separate payment rate for each of six types of home health visits (skilled nursing, home health aide, physical therapy, occupational therapy, speech therapy, and medical social services) was tested. The study looked at the effects of this payment method on agency operations, service quality, and expenditures. It also analyzed the relationship between patient characteristics and the cost and utilization of home health services. The findings suggested that demonstration sites had not decreased their cost per visit, had increased their total revenues and net revenues, or had altered their behavior in ways that affect the quality of home health care.

Evaluating the Effects of Physician Payment Reform on Access: Time Series Analyses of Hospitalizations for Ambulatory-Care Sensitive Conditions looked at the effects of physician payment reform (PPR) on access to care in the Medicare population by studying patterns of hospitalization for ambulatory-care sensitive (ASC) conditions. This project analyzed the trend in rates of hospitalization for selected ASC conditions to see whether there is a discontinuity in the time series associated with the implementation of PPR. Analyses were compiled for the trend in hospitalizations for one ASC condition, congestive heart failure (CHF). No significant discontinuity was found in hospitalizations for CHF with the implementation of PPR.

Effects of Predetermined Payment Rates for Home Health Care is a study of the Home Health Per-Visit Prospective Payment Demonstration that pays home health care agencies a prospectively set rate for home health visits, thus providing an incentive to these agencies to control their costs of delivering Medicare home health visits. The study shows that this incentive was largely overwhelmed by the current home health care environment, which is characterized by diversity, change, and competitive pressures. Nonetheless, the opportunity to earn a profit and the increased possibility of losses may have slightly increased the level of attention agencies gave to cutting costs. Prospective rate setting had no discernable effect on the number of visits provided by agencies or on patients' other Medicare costs, quality of care, access to care, or use of services not covered by medicare.

Trends in Access to Health Care Services for Selected Segments of the Medicare Population were developed for the years prior to, during, and after implementation of PPR. The focus was on vulnerable subgroups of the Medicare population, such as persons with low income, persons without supplemental medical insurance, and persons with acute and chronic conditions. Geographic differences also were examined. These trend data were derived from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics. The years 1984, 1986, 1989, 1990, and 1991 were used to develop pre-PPR baseline data. The years 1992 and 1993 were used to develop post-PPR data. Pre- and post-PPR data from the NHIS showed that health insurance and health status are both important determinants of the use of physician services.

Assessment of the Impact of Pharmacy Benefit Managers looked at companies that apply managed care principles to prescription drug programs. Their objective is to ensure optimal and cost-effective drug prescribing and use. The project characterized these firms, compared the costs and quality of care (pharmacy benefits) in Medicaid programs versus pharmacy benefit managed care for the privately insured and for Medicaid enrollees in managed care. The project found that these firms did provide both administrative functions and drug use control, that they were dispersed throughout the country and covered substantial numbers of beneficiaries, that this aspect of the health care industry is complex and rapidly changing, and that they offer various programs (e.g., Medicaid, extensive provider networks, favorable market reimbursement rates for pharmacies, and sophisticated claims processing and data management systems).

The Evaluation of Medicare SELECT Amendments looked at a pilot Medicare supplemental insurance product under which full Medigap benefits are paid only when services are provided by the plan's provider network. Case studies were conducted. The analytical portion of the project compared cost and use of Medicare and supplemental services, selection effects, beneficiary satisfaction, and physician practice patterns with other Medigap options.

Evaluations in Progress

ORD currently supports 32 evaluation projects in progress, 24 of which are scheduled to be completed in FY 1997. These projects provide information for continued monitoring of the Medicare and Medicaid programs and assess the impacts of HCFA's Medicare and Medicaid demonstration projects.

Medicare Projects

Results from the following evaluations are expected in FY 1997.

The Evaluation of Medicare SELECT looks at a pilot Medicare supplemental insurance product under which full Medigap benefits are paid only when services are provided by the plan's provider network. Case studies are being conducted. The analytical portion of the project will compare cost and use of Medicare and supplemental services, selection effects, beneficiary satisfaction, and physician practice patterns with other Medigap options.

The Evaluation of the Medicare Case Management Demonstrations studies the appropriateness of providing case management services to beneficiaries with catastrophic illnesses and high medical costs. It will test case management as a way of controlling costs in the fee-for-service sector.

The Medicare Participating Heart Bypass Center Demonstration Extended Evaluation continues to study the feasibility of a negotiated all-inclusive pricing arrangement for coronary artery bypass graft surgery while maintaining high quality care. The project will look for any net cost savings to the Medicare program, any volume increases at the demonstration sites, the aspects of the demonstration that were attractive to beneficiaries and referring physicians, and whether the quality of care at the sites was equivalent to that provided prior to the demonstration.

Monitoring and Evaluation of the Medicare Cataract Surgery Alternate Payment Demonstration assists HCFA in tracking this set of demonstrations, which test the feasibility of an all-inclusive negotiated (bundled) price for cataract surgery. The price covers the physician, facility, and intraocular lens costs. The analysis portion of the project tests whether there were any net savings to the Medicare program, changes in the use of services included and excluded from the bundle, beneficiary satisfaction, and quality of care.

In the Impact of the Medicare Fee Schedule on Access to Physician Services, HCFA is evaluating the effect of the physician fee schedule on the beneficiary's access to care. Six different strata of beneficiaries are selected based on the relative size of the payment change under the fee schedule compared to the earlier payment scheme. The project is examining use of services, outcomes of services, and the change in the beneficiary's financial liability.

The Evaluation and Technical Assistance of the Medicare Alzheimer's Disease Demonstration assists with HCFA's projects that provide comprehensive in-home and community-based services to beneficiaries who have dementia. Two different models of care are involved in the demonstration, differing by the intensity of the case management and the amount of service costs covered each month. The analytical portion of the contract is attempting to identify the factors associated with cost-effectiveness, the services that appear to affect the health status and functioning of the patients, the effects on the caregiver (burden and stress), and whether the provision of the additional home care services delay or prevent institutionalization.

In later years, the following Medicare projects are expected to be completed.

The Evaluation of HMO Outlier Demonstration that examining the Outlier Pool Demonstration that is under way in the Seattle area. Participating plans are paid 97 percent of the adjusted average per capita cost, with 2 percent of the payments going into a pool. Plans with a higher than average incidence of high-cost cases will receive more from the pool than they paid in, and those with a lower incidence will receive less.

The Evaluation of the Medicare Choice Demonstration assesses the feasibility and desirability of new types of managed care plans for Medicare. These plans can be integrated delivery systems and preferred provider organizations.

The Medicare HMO Evaluation updates the findings of an earlier study of Medicare risk health maintenance organizations. That study found that 5.7 percent more was paid for plan enrollees than would have been spent under fee-for-service. The current study looks at disenrollment, beneficiary satisfaction, quality of care, and selection and savings.

HCFA is experimenting with paying skilled nursing facilities on a prospective basis. Currently, such facilities are reimbursed on a retrospective cost basis. This demonstration uses a case-mix classification, called Resource Utilization Groups, to classify patients. The Evaluation of the Nursing Home Case-Mix and Quality Demonstration seeks to estimate specific behavioral responses to the prospective payment and to test hypotheses about aspects of such responses. The main goal of the project is to estimate the effects on the health and functioning of the nursing home residents, their length of stay, and use of health care services; on the behavior of the facilities; and on the level and composition of Medicare expenditures.

Medicaid Projects

The following Medicaid-related evaluations are scheduled for completion in FY 1997.

The State of Delaware is experimenting with its Medicaid program under the assumption that by enrolling children into a managed-care system, they will reap the benefits of a higher level of coordinated care while benefiting from lowered costs. The Evaluation of the Demonstration Entitled Delaware Health Care Partnership for Children is examining this real-time test of the hypothesis.

The Evaluation of Medicaid-Managed Care Programs With 1915(b) Waivers will provide information on the extent to which various features of the waiver projects contribute to the ability of the Medicaid program to deliver cost-effective care to eligible populations.

The Evaluation of the Utah Prepaid Mental Health Plan: Coordinated Care Systems as Alternatives to Traditional Fee for Service looks at Utah's project which has three mental health centers providing mental health services to all Medicaid beneficiaries in their catchment areas (these areas include over 50 percent of all Utah Medicaid beneficiaries). The State hopes this program will control the cost inflation and improve patient outcomes.

The Evaluation of the Iowa Implementation of Ambulatory Patient Groups (APG's) studies a Medicaid outpatient prospective payment system that groups patients for payment purposes rather than paying on a cost basis. It involves a case study on Iowa's implementation of the APG system and an analysis of the reimbursement methodology.

The Comparative Study of the Use of Early and Periodic Screening, Detection, and Treatment and Other Preventive and Curative Health Care Services by Children Enrolled in Medicaid is examining the effects of the 1989 changes to this portion of the program. It is looking at the process of providing health services and the appropriateness of expenditures for services in four States. It compares Medicaid children with other Medicaid-enrolled children in the same State who are not receiving these services, with emphasis on preventive services. Using national survey data, it also compares Medicaid-enrolled children with non-Medicaid-enrolled children, insured and uninsured, on the use of and expenditure for preventive and other health services.

The Evaluation of the Demonstration for Improving Access to Care for Pregnant Substance Abusers is assessing the effectiveness of projects that improve outreach and assessment; expand, integrate and coordinate program services; and improve client case management. The evaluator will look at access to prenatal care, substance abuse treatment services, and other relevant services. It will assess the effects of services on the health of the drug-addicted pregnant women, any prevention of reduction or short-term impairments to their infants, and the impact on birth outcomes.

The Evaluation of the Medicaid Uninsured Demonstrations covers projects in Maine, South Carolina, and Washington State. They test the effects of extending Medicaid coverage to low-income families. The evaluator will look at the ability of the programs to enroll significant numbers of eligible persons, the conditions under which these persons are willing to participate, the program's ability to induce adequate numbers of providers to participate, the effect on service utilization and health outcomes, their cost-effectiveness, and the extent to which these demonstrations' interventions could be applied nationally.

The Examination of the Medicaid Expansions for Children will use enrollment and expenditure trends to ascertain the impact of the 1989 program changes. It will look the penetration of the target population, and the impact of State policies (and the eligibility group) on enrollment, expenditures, and utilization of services.

The Department is required to report to Congress on the relative quality of care in the Medicaid program. HCFA's Medicaid Quality of Care Study examines the necessity, appropriateness, and effectiveness of selected medical treatments and surgical procedures for Medicaid patients. It is assessing the variation in the rate of performance of selected treatments and procedures on Medicaid beneficiaries for small areas within and among States. It is determining underutilized, medically necessary treatments and procedures for which failure to furnish them could have an adverse effect on their health status.

The Community-Supported Living Arrangements Program: Process Evaluation is designed to test the effectiveness of developing a continuum of care concept as an alternative to the Medicaid-funded residential services provided to individuals with mental retardation and related conditions. The program serves individuals who are living in the community--either independently, with their families, or in homes with three or fewer other individuals receiving the same services.

The Project Demonstrating and Evaluating Alternative Methods to Assure and Enhance the Quality of Long-Term Care Services for Persons With Developmental Disabilities Through Performance-Based Contracts With Service Providers tries to determine whether and how well the implementation of new approaches to quality assurance, with outcome-based definitions and measures of quality, will replace input and process measures of quality in this population group.

In addition, HCFA has other major Medicaid evaluations whose results are anticipated in several years.

HCFA is sponsoring a wide variety of waiver-based demonstrations that give States the opportunity to experiment with their Medicaid programs. As these demonstrations are begun, HCFA undertakes examinations of their impact. The Evaluation of the Oregon Medicaid Demonstration, the Evaluation of the State Medicaid Reform Demonstrations (in Hawaii, Rhode Island, and Tennessee), and the Evaluation of the State Medicaid Reform Demonstrations (in Ohio and Minnesota), are three such projects. More will be started as more State demonstrations are begun.

The Drug Utilization Review Evaluation is looking at the impacts of retrospective and prospective review, which include the payment of pharmacists for cognitive services. Data from demonstrations in Iowa and Washington State and information from programs in other States serve as the basis for this study. Maryland and Georgia will serve as coexperimental and comparison States.

Other Health Financing Policy and Demonstration Evaluation Projects

In 1977 Congress authorized a new type of provider--the rural health clinic. A rural health clinic must be located in a rural health professional shortage area, medically underserved area, or governor-designated shortage area, and must make use of mid-level practitioners. Rural health clinics are reimbursed on a cost-basis by the Medicare and Medicaid programs. Their numbers have been growing at a relatively rapid rate. The Evaluation of Rural Health Clinics examines the reasons for this growth, the impact on access to care for these rural populations, and the costs to the Federal Government and the States.

Evaluation of the Essential Access Community Hospital/Rural Primary Care Hospital Program examines the development, implementation, and early operating experiences of this program. Known as EACH/RPCH, the program is supposed to assist States in maintaining access to health care services in rural areas. This is done through the development of rural health plans, establishment of rural health networks, and creation of a limited service alternative for communities that can no longer support a full-service hospital.

The Evaluation of the Community Nursing Organization Demonstration looks at a set of projects mandated in 1987. The legislation directs projects in four or more sites to test a capitated, nurse-managed system of care. The two fundamental elements of these demonstrations are capitation payment and nurse case management. They are designed to promote timely and appropriate use of community health services and to reduce the use of costly acute-care services.

The Evaluation of the Program of All-Inclusive Care for the Elderly Demonstration, known as PACE, examines the replicates of a unique model of managed care service delivery for very frail community-dwelling elderly, most of whom are dually eligible for Medicare and Medicaid coverage and all of whom are assessed as being eligible for nursing home placement. The core services include adult day health care and multidisciplinary team care management through which all health and long-term care services are arranged. The evaluator is looking at the demonstration sites before and after assumption of financial risk to see if the replicates are cost effective relative to the current Medicare and Medicaid services. They are also looking at the decision to enroll to understand how PACE enrollees differ from the eligible beneficiaries who choose not to enroll.

The Inspector General of the Department is conducting a demonstration of improved methods for investigating and prosecuting fraud and abuse. The Evaluation of the Effectiveness of the Operation Restore Trust Demonstrations will determine whether the more concentrated effort rendered through the demonstration's partnership model has a relatively greater impact on industry fraudulent behavior.

The Evaluation of the Impact of Health Plan Report Cards on Consumer Knowledge, Attitudes, and Choice in a Managed Competition Setting seeks to determine whether the dissemination of information about health plans to consumers (who choose health plans within a managed-care competition framework) will influence their knowledge of plan characteristics, attitudes toward the plans, or choice of plan.

New Directions for Evaluation

As the U.S. health care system continuously changes, there is a clear need for developing, designing, and testing new ways to monitor and evaluate its performance. It is important that monitoring and evaluation efforts for the Medicare and Medicaid programs include a number of critical dimensions (access to care, quality, efficiency, costs, and beneficiary satisfaction) to provide an understanding, on an ongoing basis, of how well the programs are performing. ORD is working to develop a comprehensive monitoring and evaluation plan for systematically examining the Medicare and Medicaid programs.

HCFA also will continue to develop a wider array of evaluation and measurement tools. The agency's evaluation activities will continue to examine specific policy issues within the HCFA programs. For example, as Medicare and Medicaid continue to pursue managed care options, ongoing work will examine the cost-effectiveness of, quality of, and beneficiary satisfaction with managed care. HCFA plans to carry out projects to monitor and compare the health status or health risk behaviors of beneficiaries in various delivery systems and how these change over time.

Finally, as HCFA develops and implements new high priority demonstrations that will test new payment and health care delivery models for the future, the agency will evaluate these programs and provide information to policymakers about the impacts of these alternatives.

Health Resources and Services Administration

MISSION: Improve the health of the Nation by assuring quality health care to underserved, vulnerable, and special-need populations and by promoting appropriate health professions workforce capacity and practice, particularly in primary care and public health.

Evaluation Program

The purposes of the Health Resources and Services Administration (HRSA) evaluation program are to enhance strategic planning, budget decisions, legislative planning, and program management. Consequently, major emphases during FY 1997 and beyond will be (1) performance measurement, (2) assessment of program implementation, and (3) cross-cutting policy analysis and research.

Performance measurement includes technical assistance and training activities to strengthen the agency's capacity to assess program performance, as well as studies to assess program outcomes. These activities, mandated by the Government Performance and Results Act (GPRA), will provide data for ongoing program monitoring and evaluation and for developing annual performance plans and budgets. A study completed in September 1995 established a performance measurement baseline for all operating programs, with the ultimate objective of ensuring that the HRSA specifies valid and useful indicators and measures for all programs by September 1998. Over the past two years, the HRSA has made significant progress in performance management, such as strengthening linkages among strategic planning, program activity, and the budget process.

Assessment of program implementation includes a broad range of efforts to assist the agency during a time of new directions from the Administration and Congress. HRSA programs are entering into new arrangements for delivering services, providing health professions education, and encouraging the development of systems reform within seven Program Priority areas. These priorities reflect the HRSA's focus on the communities where underserved populations live, and include academic and community partnerships to foster clinical training in community-based settings; new arrangements to bring poor, uninsured, rural, and chronically ill persons into the mainstream of managed care; assistance to communities in strengthening their health care infrastructure; and new activities with States. All agency studies relate to one or more of these Priorities, which also include improved comprehensiveness and integration of HIV/AIDS programs; school-based care for children and adolescents; and activities to enhance the health of people living along the U.S.-Mexican border.

Cross-cutting policy analysis and research includes efforts to build capacity and conduct studies to clarify the environmental shifts within which HRSA programs operate and to improve the HRSA's ability to document performance and impact through better measurement tools and data sources. Developing this capacity at the agency level and initiating some studies are special priorities for FY 1997; work in later years will build on these beginnings. "Cross-cutting" implies policy issues that bear on the programs of two or more HRSA Bureaus, such as trends in numbers and characteristics of the uninsured and the health of the safety net.

The main purpose of the HRSA's evaluation program is to provide accurate and relevant information on a timely basis to the administrator and other senior line managers. In working toward this objective, HRSA subjects study proposals to a formal review process, which begins with consideration by a committee comprised of senior line officials and is chaired by the Director of the Office of Planning, Evaluation and Legislation (OPEL). This committee's task is to assess the relevance of the proposals to important policy, budgetary, or legislative issues; its potential to answer questions about program effectiveness or impact; its degree of attention to cross-cutting topics; and its relative priority for funding. Following administrator decisions on approval of the recommended studies, a committee of senior analysts from the HRSA, the Agency for Health Care Policy and Research, the National Center for Health Statistics, and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) reviews scopes of work and other substantive portions of documents needed for development of contracts. The role of this technical review group is to suggest ways to strengthen study design or data sources.

HRSA is continuing to place major emphasis on disseminating findings and information about use of study results. This is done through inclusion of abstracts in the ASPE evaluation data base (on the Internet), submission of articles to peer-reviewed professional journals, presentations by HRSA staff at professional conferences, and placement of final reports with the National Technical Information Service. In addition, the HRSA prepares annual volumes of summaries of studies begun or completed the preceding fiscal year. These are distributed within the department and their availability is noted on the HRSA OPEL web page at http://www.hrsa.dhhs.gov/oa.html#opel.

Summary of Fiscal Year 1996 Evaluations

During FY 1996, HRSA completed evaluations in the following areas.

Performance Measurement

Projects to build on the baseline study on performance measurement noted above were a major emphasis during the past year; they included technical assistance tailored to the needs of each of the four Bureaus. Illustrative of this work was the Evaluation of the Bureau of Health Professions Strategic Directions: Phase II, which developed a set of outcome-based performance measures and a plan for a performance-monitoring system to support ongoing program management and compliance with GPRA requirements. This study is featured in chapter II.

Relevant to HRSA's continued efforts to identify appropriate health outcomes indicators, the agency conducted a Consensus Conference on Health Status Gaps of Low-Income and Minority Populations. The report recommends potential measures and data sources for eight conditions, sets of conditions, or preventive approaches: diabetes; hypertension, cardiovascular, and cerebrovascular conditions; breast cancer; cervical cancer; infectious diseases, including AIDS, sexually transmitted diseases, and tuberculosis; immunization; asthma; and pregnancy outcomes.

Another HRSA effort developed quality assurance procedures for the Uniform Reporting System for Titles I and II of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which provide grants to disproportionately affected metropolitan areas and States. The purpose of the funding is to improve the availability and coordination of services for persons with HIV/AIDS. Under the Uniform Reporting System, grantees submit provider-level administrative data and data on client demographics and services received. Uniform data are used to assess the extent to which grantees are achieving the goals of the Act and to help metropolitan planning councils, State agencies, and State consortia target and monitor the provision of services to specific population groups. Through this study, data quality targets were established and manuals were written to help grantees compile high-quality data. HRSA and grantee staff are using the results to improve the quality of data submissions, which will support national and local program monitoring and evaluation.

Managed Care

Managed care will continue to have a major influence on HRSA programs. This topic was looked at in two studies: An Evaluation of the Impact of the Social Security Act Section 1115(a) Waivers on Federally Qualified Health Centers was designed to investigate how federally qualified health centers (FQHC's) have fared in Hawaii and Oregon, both of which have waivers involving placement of Medicaid eligibles in managed care organizations. The study found that the waiver programs expanded access to primary care and dental services, and that FQHC's continued to provide types and levels of services not included in the capitation rates, as well as to serve patients not covered under the waiver program. Study results are being used by State and Federal policymakers concerned with Medicaid managed care programs and have been disseminated to managed care organizations that are part of Medicaid managed care programs.

Additionally, tools were developed for monitoring the cultural competence of primary care providers practicing in managed care systems. The work was carried out through physician and patient panels in two California HMO's serving predominantly Latino or Chinese populations, and through a literature review. "Cultural competence" was defined as the level of knowledge-based skills required to provide effective clinical care to patients from a particular ethnic or racial group. A related concept, "cultural sensitivity," was defined as the psychological propensity to adjust one's practice style to the needs of different ethnic or racial groups. Study products include a patient satisfaction questionnaire, which a managed care plan could use to assess the degree to which enrollees with limited English believe their care is culturally competent; a provider self-assessment questionnaire; and behavioral ethnic identifiers that can be used in enrollment processes as a cue for designing culturally appropriate services.

Primary Care

Primary Care: America's Health in a New Era was a major undertaking carried out by the Institute of Medicine to define and describe the place of primary care in the changing health care environment and to develop a set of normative goals for primary care. Findings focus on interdisciplinary primary care teams, roles of the different providers that make up the teams, and ways in which team members could interact with each other and with providers outside the team. The study report is being used to inform the health care community about primary care issues for the next decade.

Assessing the Impact of Public Spending on the Health of Vulnerable Populations: A Framework for Evaluating HRSA Programs provides a structure for describing the linkages among HRSA dollars and HRSA-funded services, HRSA-enabled resource- and infrastructure-building programs, and the populations affected in terms of health outcomes. The analytic approaches developed here could be used by the HRSA or other operating divisions to explain the difficulties in establishing causal factors, to highlight areas with the greatest need for surveillance and monitoring, and to develop data systems to provide the needed information.

A study entitled Impact of Case Management on Health Status in Community and Migrant Health Centers (CMHC's) examined case management practices and their impact on health status of participants in the Comprehensive Perinatal Care Program (CPCP). The study consisted of three components: a control-site study of paired CMHC's, intensively using and not intensively using case management; a model-site study of seven CMHC's serving high-risk perinatal populations; and a two-part mail and telephone survey of a sample of centers receiving CPCP funding. The study found that case management had a positive impact on the continuity and adequacy of care, on the content of care in some areas (psychological risk assessment and health promotion), and on users' perceptions of care. The HRSA is using the findings to integrate case management in all primary care projects serving perinatal patients. The study also developed a self-assessment tool that grantees can use to evaluate their case management activities.

Finally, Technical Support for Need Designation and State Primary Care Access Plan Initiatives assessed the process for designating areas of primary health care shortage. Results are being used in finalizing new designation criteria for shortage, underservice, and access barrier areas.

Care for Mothers and Children

The Emergency Medical Services for Children (EMSC) program was begun in 1984 to help States develop and institutionalize emergency medical services for critically ill and injured children. This past year, HRSA completed a study to assess the extent to which seven States had sustained services funded with an EMSC grant, to identify attributes associated with successful institutionalization of EMSC in State emergency medical services systems, to characterize barriers to institutionalization, and to recommend approaches for Federal actions to improve EMSC systems. Recommendations, which include three areas (strategic planning and funding; grant guidance, including an increased emphasis on evaluation; and program development and intergovernmental relations), will be used by program managers in setting future directions and goals.

Health Professions

One project in the health workforce area developed the Report to Congress on the Process by Which International Medical Graduates Are Licensed To Practice in the United States. This study assessed the time required to verify the credentials of physicians applying for licenses and differences in the application process for international versus U.S. medical graduates. The study found that there is a time differential between these groups of graduates and that a national credentials verification system is needed to assist State medical boards. The study also recommended that uniformity among States in licensure requirements be expanded to a maximum degree.

Another study assessed the feasibility of increasing the production of advanced practice nurses by investigating the potential for nursing educational institutions to expand their capacity. "Advanced practice nurses" include nurse practitioners, clinical nurse specialists, nurse anesthetists, and certified nurse midwives. The study found that the single most significant factor in determining an institution's ability to expand capacity is the availability of sites for clinical education, although the availability of clinical faculty is also important. HRSA is using the results to guide future directions for advanced practice nursing programs and to provide technical assistance to grantees. The report has also been shared with schools of nursing with advanced practice programs.

A third health professions study was an exploratory effort to describe arrangements between primary care residency programs and ambulatory training sites affiliated with them. The most important findings are that (1) residency programs do not significantly offset the costs of ambulatory training experienced by the sites nor are there many written agreements in place; (2) residency programs are not aggressively seeking managed care training sites; and (3) cost pressures on ambulatory training sites may make decisionmakers less willing to assume or continue to absorb the cost of training. HRSA will use these findings, in conjunction with findings from two other studies on site-specific costs of ambulatory training, to expand understanding of the costs of ambulatory education and help HCFA in its deliberation on new approaches to GME funding.

Evaluations in Progress

During FY 1996, HRSA had evaluations under way in the following areas.

Performance Measurement

A study entitled Health Care Status Outcome Measures for the Bureau of Primary Health Care: The Assessment of Ambulatory Care Sensitive Conditions Through State Medicaid Recipient Files is comparing the relative risk of inpatient hospitalizations of community health center users with that of nonusers for ambulatory care-sensitive conditions. This project builds on the Consensus Conference noted above. The third study identified below under Managed Care, Meeting Industry Standards for Performance Measurement Through Clinical Outcome Measures at Community and Migrant Health Centers, also applies here.

Managed Care

A number of studies will continue several of the major themes and initiatives. For example, Evaluation of the Response to Medicaid Managed Care Initiatives by Federally Qualified Health Centers will describe strategies that FQHC's are using to incorporate Medicaid managed care into their practices and assess the impact of these strategies on FQHC organization, delivery of services, and market position. Findings will guide policy for CMHC's. Building on a study completed in FY 1995, the Performance Assessment of Managed Care in Community and Migrant Health Centers will develop case studies in seven centers. Center performance will be compared with that of other providers in the same HMO network on selected industry performance indicators.

Work will also continue to examine the extent to which CMHC's are using clinical outcome measures to assess quality of health care, to meet center needs in a managed care environment, and to improve and monitor the quality of care locally and nationally. Findings will be used to identify performance issues needing further research and development and to facilitate collaboration among private and governmental organizations focused on health outcome measures and underserved populations.

Two studies are examining staffing issues in a managed care context: HMO Staffing Strategies in Underserved Areas is describing strategies to ensure access to services for enrollees in underserved areas, as well as the implications of these strategies for overall access in these areas. The study involves interviews and other data collection at nine HMO's with significant Medicaid enrollment. Selected Aspects of Education in Managed Care is surveying managed care organizations to identify their practices and determine the potential for these organizations to provide high-quality learning experiences for medical students and residents.

Primary Care

The Community Health Center User and Visit Survey, which involves personal interviews of users at a representative national sample of centers and a review of patient records at the same centers, continues from FY 1994. One of the purposes is to gather data on characteristics of users and types of services they received on a basis that will permit comparison with the results of the National Health Interview Survey. A related study begun during FY 1996 is expanding the analysis of the User and Visit Survey data to compare managed care users with users of centers that are not part of managed care arrangements.

Casemix Differences in Health Centers and Other Providers and Their Relationship to Cost will recommend a method for measuring casemix (severity of illness) in ambulatory populations; develop a methodology for creating "casemix profiles" of patient characteristics and expenditure data; and test the methodology with Medicaid data from several States. This study should also provide insights into the relative importance of casemix compared with other factors that may affect expenditures for primary care in the ambulatory setting.

HRSA is continuing to work with the American Hospital Association Hospital Research and Educational Trust (HRET) on evaluation of the HRET-sponsored Community Care Network, a series of demonstrations in 25 sites across the United states. HRSA support for this collaboration was begun through a project completed last year, National Demonstration of the Community Care Network Vision: Development of a Program Evaluation. HRSA will use the findings from the evaluation as a guide for selecting model types or community characteristics that deserve detailed exploration to form hypotheses about attributes that may lead to the successful launching of collaborative activities and to assess implications for cost-effective approaches to measurement and data collection in future evaluations of HRSA programs.

Another study concerns the ability of HRSA-supported community-based organizations to integrate services for individuals with multiple risk factors, such as HIV/AIDS, substance abuse, and homelessness. This project has explored the use of multiple funding sources to provide integrated care, barriers to integration of services supported by separate funding sources, successful integration strategies, and ways in which HRSA might reduce barriers created through multiple funding streams. The results will inform policy on primary care and AIDS programs and will be shared with other operating divisions.

Attention to bilingual and multilingual services is also continuing through studies directed to services at CMHC's, such as the project, An Assessment of Bi/Multicultural Services Offered at Community and Migrant Health Centers. Bilingual Assistance Program: Evaluation of Strategies for Reducing Cultural and Linguistic Barriers to Health Care for Hispanic and Asian Pacific Islander Populations concerns bilingual services in the context of small grants to State and local health departments.

Health Care for Mothers and Children

The National Evaluation of the Healthy Start Program continues as a 5-year longitudinal study of the development, implementation, and outcomes of the comprehensive perinatal delivery systems at the initial 15 Healthy Start sites. This project includes an assessment of changes in the health status of pregnant women and infants across the sites. The study is designed to answer four questions: Did the Healthy Start initiative succeed? If so, why? If not, why not? What would be required for a similar intervention to succeed in other settings?

HIV/AIDS

A major priority of the HRSA is to improve access to a comprehensive continuum of care for persons with HIV/AIDS, through the Ryan White CARE Act programs. One ongoing study concerns the management of people infected with both AIDS and TB in metropolitan areas with Title I grants to identify models of successful collaboration between HIV/AIDS and TB control programs. The project is also determining the extent to which specific Title I grantees are providing guidance to funded providers on TB screening and prophylactic and therapeutic regimes. Another study is reviewing and synthesizing HIV-related consumer-level evaluations conducted by CARE Act grantees across the country. The intent is to identify useful and replicable models of studies for use in providing technical assistance to grantees, and to identify topics on which further studies are needed.

Organ Transplantation

One of the HRSA's roles is to oversee the national system for distributing organs for transplantation. An ongoing study is examining the reasons why African Americans remain on waiting lists longer than white patients. Anecdotal evidence indicates that African Americans are more difficult to contact within allowable time periods than whites and that African Americans are more likely to decline an organ offer. Studies on this subject have been inconclusive, however. Findings will be used to assess whether changes are needed in HRSA policy concerning the transplantation network.

Telemedicine

Another significant policy area involving ongoing work is the rural applications of telemedicine. In FY 1994, the HRSA began a baseline project to determine the current status of telemedicine in rural health; to explore the effects of telemedicine on access to care, practitioner isolation, and development of health care networks; to identify organizational factors that aid or impede the successful implementation of telemedicine systems; and to develop and refine data collection instruments for use in subsequent evaluations.

Health Professions

The Sixth National Sample of Registered Nurses will provide new data on the characteristics of the registered nurse workforce and will contribute to the data base underlying models for projecting national nurse supply and requirements. Data from the survey will be used by the HRSA to guide nurse education programs and to prepare biennial reports to Congress on characteristics of the registered nurse population. Results will also be used by the nursing community, which looks to the Department to maintain and update this unique data base.

The cost and location of training of physicians and others to provide primary care in ambulatory settings is a continuing concern. One project is obtaining quantitative data on the costs involved in training medical students and residents in over 30 ambulatory sites across the country.

A collaborative study with the Educational Commission on Foreign Medical Graduates and the Appalachian Regional Commission is tracking exchange students granted a J-1 visa to participate in graduate medical education in the United States. The HRSA portion of the project will examine the postresidency experience of exchange visitors who have secured waivers to remain in the United States following completion of training for the purpose of providing services in an underserved area.

New Directions for Evaluation

As in FY 1996, the HRSA will emphasize performance measurement, managed care, and such primary care programs as CMHC's. Care for mothers and children (exemplified by Healthy Start initiative), HIV/AIDS (including new approaches to financing and delivering care tested through the Special Projects of Regional and National Significance), and strengthening of the health care infrastructure at State and local levels will also be major areas of attention. Ongoing and new efforts that involve collaboration with other operating divisions and with such external entities as foundations and the American Hospital Association will also be continued or developed. Finally, the HRSA will ensure the further integration of evaluation with strategic planning and budget decisions and presentation, as called for in GPRA.

Indian Health Service

MISSION: To provide a quality health services delivery system for American Indians and Alaska Natives with opportunity for maximum tribal involvement in developing and managing programs to meet health needs.

Evaluation Program

The goal of the Indian Health Service (IHS) is to raise the health status of its principal beneficiary, American Indians and Alaska Natives, to the highest level possible. The importance of evaluation in supporting this goal has increased significantly in recent years. The IHS evaluation process seeks to include American Indians and Alaska Natives as primary stakeholders in defining the purpose, design, and execution of evaluations. Stakeholders are the users of the end product of evaluations and typically are the population or groups most likely to be affected by the evaluation findings. The principles of responsive evaluation practice have been adopted by the IHS because they can best address these needs and concerns of American Indians and Alaska Natives.

The purpose of the Office of Planning, Evaluation and Legislation (OPEL) is to advise the Director of the IHS on policy formulation; to conduct and manage program planning, operations research, program evaluation, health services researches, legislative affairs, and program statistics; to develop the long-range program and financial plan for the IHS in collaboration with appropriate agency staff; to coordinate with HHS, Indian Tribes, and organizations on matters that involve planning, evaluation, research and legislation; and to develop and implement long-range goals, objectives, and priorities for all activities related to resource requirements and allocation methodologies and models. OPEL serves as the principal advisory office to the IHS on issues of national health policy and coordinates these four evaluation functions.

OPEL meets part of the IHS evaluation needs with two major types of short-term studies: policy or program assessments and evaluation study. The policy study contributes to IHS decision making about budget, legislation, and program modifications and includes background information to support IHS initiatives. Evaluation studies are carried out at the program level, or area offices, and focus on specific program needs.

Annually, OPEL identifies the high-priority health care and health management issues and concerns through the submission of headquarters and area office proposals for assessment or evaluation. IHS area and associate directors submit proposals for possible areas of evaluation study. These proposals are reviewed and rated by a panel of subject-matter experts and evaluation experts and also reviewed by IHS staff for more specific concurrence with IHS strategic goals, objectives, and priority areas. The proposals are then ranked by priority and forwarded to the OPEL Associate Director for review and approval. The Director of the IHS reviews the final proposals and decides the respective funding levels.

Summary of Fiscal Year 1996 Evaluations

During FY 1996, OPEL completed three evaluation projects of several major Indian health topics.

Methodology for Adjusting IHS Mortality Data for Inconsistent Classification of Race-Ethnicity of American Indian and Alaska Natives Between State Death Certificates and IHS Patient Registration Records

The study findings indicate a large variation in the number of deaths reported from 1986 to 1988 across IHS area offices and extensive variation in the number of deaths reported in the matched IHS-National Death Index data across States of occurrence. There is also a great variation in the percentage of consistently reported American Indian and Alaska Native race identification on State death records and IHS patient registration records by State of a resident. Recommendations include replicating the study using data on deaths occurring since 1988, using the adjustment factors developed in the study, and working with States to decrease inconsistent race reporting.

Evaluation of the Indian Health Service (IHS) Adolescent Regional Treatment Centers

The principal conclusion based on this study's findings is that regional treatment centers have developed effective adolescent alcohol and substance abuse programs. The continuity of care and aftercare, however, is the biggest problem. The regional treatment centers need additional mental health staff resources, client charting improvements, and innovative ways to increase family involvement. Recommendations include improving the continuum of care to adolescent substance abusers, self-evaluation, and regional treatment center effectiveness and efficiency.

Evaluating the Effectiveness of Alcohol and Substance Abuse Services for Native American and Alaska Native Women: Phase II Final Report

This evaluation provides both qualitative and quantitative information about a group of women that has been traditionally underrepresented in research. The life conditions of women about whom information was gathered are extreme, and for many women, adverse or abusive childhood experiences and conditions have carried through to adulthood. The vast majority of women were exposed to various types of abuses--such as physical, sexual, and emotional abuse--from childhood to adulthood. Women entered treatment through a variety of ways. Those who were mandated tended to enter treatment as an alternative to incarceration. Women hear about the availability of services through the court system, word-of-mouth, or through a community or an American Indian and Alaska Native social service agency. Women in the focus groups tended to select their current alcohol and other drug treatment program over alternatives because of its focus on American Indian and Alaska Native tradition and culture. The women and staff also espoused the benefits of the family-like environment that the treatment centers promoted. The availability of women-centered, family-focused approaches to alcohol and other drug treatment is severely limited in the United States. Several barriers to services for potential participants exist. The leading obstacle for parenting women is the lack of child care for their children while in treatment. It was strongly emphasized that a woman's recovery was dependent on three key factors: herself, her social networks, and her community. One of the strongest impressions that has been derived from this evaluation is that the women who have participated in alcohol and other drug treatment programs are, overall, a cadre of strong women.

Evaluations in Progress

During FY 1996, the IHS funded more than ten projects, including health program evaluations, policy analysis projects, health services research, and special studies and initiatives. Examples of evaluations in progress follow.

Elderly Wellness

This study will focus on collecting data to determine if the provision of health care and health promotion services specially designed for the elderly will increase their use of these services and ultimately improve their health status. Comprehensive care remains an unmet need for the elderly. Recent reviews show that less than 50 percent of the elderly population residing in the Fort Peck Service Unit (Billings, Montana, area office) has had a health care visit of any kind in the last two fiscal years.

Prior Trauma Care of Intoxicated Patients as a Predictor of Subsequently Fatal Injury

In FY 1996, the IHS funded the first part of this study to begin the preliminary data collection, crude data reporting, and initial death certificate-hospital record linkage. The purpose of this study is to identify intervention opportunities associated with nonfatal, alcohol-related injuries reported in IHS emergency departments and clinics that could, over time, decrease alcohol-related injury death in the Billings, Montana, Service Units. This study will provide baseline data for postintervention comparisons by expanding the existing data base about alcohol-related injuries and death. The study will identify different intervention and prevention strategies directed at decreasing alcohol-related injuries and deaths in the Billings, Montana, Service Units. Injury-control efforts will include a new policy regarding referrals by emergency room treatment staff to alcohol treatment staff. Prevention of alcohol-related injuries and deaths will also include activities focused on informing youth about the relationship between alcohol consumption and high-risk behavior.

Resource Requirements Methodology Update

In the early 1970's, the IHS formulated the Resource Requirements Methodology (RRM) as a management tool to provide a comprehensive, systematic, and uniform process for estimating the level of resource requirements necessary to provide adequate health care to IHS customers and to assist in the allocation of unearmarked resources. To reaffirm the purpose of the RRM, a study was conducted in 1995 to determine the validity and accuracy of the present methodology for use in today's health care environment. Preliminary findings support the need to update the current methodology to meet the future program demands of the IHS. The update of the RRM will include a complete revision and documentation of the RRM and will consist of the following phases: (1) Update Staffing Criteria and Modules, (2) Formulate Needs Assessment Cost Model, and (3) Needs Assessment Model Training.

Development of a Health Services Research Agenda for American Indian and Alaska Native Populations

The IHS and the Agency for Health Care Policy and Research cosponsored a health services research conference as a first step in a long-term agenda-setting process to identify the most important health services research issues facing American Indian and Alaska Native communities and their health care systems over the next 5 to 10 years. The health services research agenda is intended to promote collaboration among American Indian or Alaska Native organizations, tribal and urban health systems, medical communities, foundations, and government agencies to increase communications and produce research information on health program services for the American Indian or Alaska Native patient. The health services research agenda is also intended to provide a forum for discussing health care reform changes that are creating new directions in the Indian health care system.

Evaluation of Indian Health Service-Supported Substance Abuse Treatment Program for American Indian/Alaska Native Women

This evaluation consists of Phases III and IV of a multiphase effort by the IHS to improve the health of American Indian and Alaska Native women who abuse alcohol or other substances. Phase I of this effort focused on designing the study, and Phase II collected descriptive data on the women who use IHS-supported substance abuse treatment centers. The primary objectives of this project are to assess and measure the treatment outcomes achieved by the women receiving treatment in the IHS-sponsored projects, to attempt to relate treatment outcomes to treatment services provided, and to describe the organization and provision of substance abuse treatment and aftercare services available for adult American Indian and Alaska Native women, identifying common strengths, problems, and recommendations for improvement.

New Directions for Evaluation

The IHS is responding to dramatic changes taking place inside and outside the Government. The causes of the many changes include a decrease in funding level of discretionary Federal programs, greater involvement of tribal governments in the Indian health care system, technological innovations, the changing patterns of disease to more chronic conditions, and the transfer of many Federal programs and resources to individual States.

These changes will affect the IHS evaluation strategy in the coming years. Nevertheless, the IHS remains committed to comprehensively community-based, preventive, and culturally sensitive projects that empower tribes and communities to overcome health issues. The Director of the IHS has increased emphasis on several initiatives to focus attention on specific health areas and to serve as a management tool to prioritize the IHS's workload. These initiatives focus on women's health, youth, traditional medicine, elder care, and establishment of working relationships with Federal and State governmental agencies. The initiatives will undoubtedly affect new directions for evaluation.

Research and evaluation proposals to be considered in upcoming years include the following topics: evaluation of the effects of medical nutrition therapy on patient outcomes among Native Americans with newly diagnosed type II diabetes mellitus, evaluation of the elders clinic at the Zuni (New Mexico) Ramah Service Unit, evaluation of the impact of the Northern Cheyenne End-Stage Renal Disease Prevention Project, and evaluation of IHS aftercare services provided by IHS's regional treatment centers.

National Institutes of Health

MISSION: To sponsor and conduct medical research that leads to better health for all Americans.

Evaluation Program

The National Institutes of Health (NIH) develops scientific knowledge that leads to improved means to prevent illness, cure disease, and treat disability. This is done by conducting medical research in its intramural laboratories and supporting research in universities, medical and health professional schools, hospitals, and other health research organizations. NIH fosters the widespread dissemination of the results of medical research, facilitates the training of research investigators, and ensures the viability of the research infrastructure. The NIH Evaluation Program is an integral part of how NIH manages its support and conduct of medical research.

Philosophy and Priorities

NIH evaluation activities assess program performance (efficiency, effectiveness, responsiveness); analyze both quantitative and qualitative results based on those assessments; and use the resulting information in policy making, strategic planning, budgeting, and program development and management.

The quantity and diversity of diseases, disorders, and biological systems in the NIH portfolio make strategic planning and evaluation at NIH a complex task that is continuously evolving. Priorities are set and research programs are planned and evaluated at two levels: the Institutes and Centers (IC's); and centrally by the NIH Director, with whom the ultimate responsibility lies for the course of NIH-funded medical research.

This two-level approach ensures that planning and priority setting specific to the mission of each IC are fully developed and implemented with a clear vision and within the fiscal constraints set by the IC budget and that there is central leadership for developing cross-cutting initiatives and promoting collaboration among the IC's. The NIH Evaluation Program provides information to assist the NIH Director and IC Directors in determining whether NIH goals and objectives are being achieved and to help guide policy development and program direction.

Policies and Operations

A distinguishing feature of the NIH Evaluation Program is the extent to which it employs a variety of evaluation strategies and inputs that include the use of national advisory councils, boards of scientific counselors, consensus development conferences, and ad hoc committees that help to chart scientific directions and select the most promising research to support.

Program evaluations are funded through both a trans-NIH mechanism, the 1-percent set-aside authority, and by individual IC program funds. A two-tier system is used to review project requests to use set-aside funding. The first tier involves a review and recommendations by the NIH Technical Merit Review Committee (TMRC) on the technical aspects of project proposals and whether a project fits within HHS guidelines for use of the set-aside fund. The second tier involves the NIH Evaluation Policy Oversight Committee (EPOC), which considers TMRC recommendations and makes final funding recommendations to the Director of NIH or his or her designee. It also conducts policy-level concept reviews of proposals for NIH-wide evaluation studies; establishes the overall NIH set-aside budget; and oversees the process. EPOC recommendations are approved by the NIH Director or his or her designee. Concurrently, the IC's fund program evaluations from their budgets that are used by various committees, working groups, task forces, workshops, conferences, and symposia to assist them and the NIH in program management and development.

One of the ways NIH sets priorities and evaluates its programs is discussion with extramural grantees, intramural investigators and other NIH staff, members of Congress and the Administration, and members of the public, including professional societies and voluntary health organizations. These individuals and groups provide valuable input on pressing public health needs, important scientific opportunities, knowledge gaps, and the balance between patient-oriented and laboratory research.

Summary of Fiscal Year 1996 Evaluations

The evaluations completed in FY 1996 addressed a cross-section of the NIH research program, including bench research, clinical research, a demonstration project, and drug research. Examples of some of these evaluations are described below.

Evaluation of NIH Shared Instrumentation Grant Programs: Reports From Users documents the results of surveys of users of costly, state-of-the-art instruments purchased through the National Center for Research Resources shared instrumentation program. The program provides equipment that is to be shared among mainly NIH-funded investigators (termed major users), and other researchers who do not have an NIH grant. The study found that 16,050 scientists nationwide used these instruments in 1993; that of these, 69 percent were NIH-supported investigators; and that three-quarters of the major users believed the instruments were essential to their research. The study also found that 70 percent of 11-year-old equipment was still in use, and that 4 out of 5 major users of this older equipment believed the equipment was adequate for their research.

Moving from bench science, the report Clinical Research in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) examined how much clinical research was being conducted in NIDDK's research portfolio, under two definitions of clinical research. The first definition required that the patient and the physician had a consultation; this was the narrow definition. The broader definition, adopted by the Advisory Committee to the NIH Director on Clinical Research, subsumed the narrow definition and also included areas of epidemiology, behavioral studies of patients, outcomes research, health services research, and technology development. The report found that in FY 1995, NIDDK spent 31 percent of its extramural budget on clinical research using the narrow definition and 37 percent of its budget using the broader definition; NIDDK spent 29 percent of the intramural budget on clinical research using the narrow definition and 33 percent using the broader definition.

Turning to evaluation of a demonstration project, the report Navajo Alcohol Rehabilitation Demonstration Program examined a federally funded program to provide culturally sensitive treatment for Navajo Native Americans who suffer from alcoholism and the effects of alcohol abuse. It is the only program to use Navajo-speaking counselors in the treatment. The evaluation found a higher level of participation in culturally sensitive therapies after completion of an inpatient treatment program, low use of aftercare services, a high program completion rate, and a low readmission rate. Data on long-term effects were not available.

Another way to treat chemical dependency is medication. The report Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector examines the National Institute of Drug Abuse's program to coordinate and encourage academic, private, and Federal regulatory involvement in developing and marketing new medications to treat drug abuse. The study found that pharmacotherapy for the treatment of drug addiction has received little attention; only two additional drugs beyond methadone have been approved, both of which were developed at least 20 years ago; and there is no approved medication for the treatment of cocaine addiction. The report noted major disincentives to pharmaceutical research and development for antiaddiction medications, among which is a lack of sustained Federal leadership. The report gives recommendations to help remove these barriers.

Evaluations in Progress

NIH supports a number of evaluations in progress. They range from small- to large-scale assessments, from evaluability studies to comprehensive evaluations. A few examples to illustrate the range include an examination of the research grant application and award processes; school health programs in Grades Kū12; evaluation of laboratory animal use, facilities, and resources; and development of a data base for NIH-supported rare disease research.

The study Career Status and Satisfaction With NIH Research Grant Application and Award Processes: A Sample Survey of FY 1992 R01 and R29 Applicants will survey individuals who applied to NIH for an R01 or R29 grant in FY 1992. The purpose is to obtain information on the current status of these individuals. Career progress and research productivity will be assessed by comparing: (1) funded principal investigators versus others supported on NIH grants; (2) principal investigators funded on grants from non-NIH sources; and (3) those who are unsuccessful in getting any support for their research. Respondents will also be asked to assess their satisfaction with the grants application and award process and to provide their opinions on specific modifications NIH is considering for improving policies and procedures.

The study Comprehensive School Health Programs in Grades Kū12, conducted by the Institute of Medicine, will assess grade-school health education, school health promotion and disease prevention, and school-based health care services from kindergarten through high school. The study will identify and examine model programs to formulate strategies for successful implementation of school health programs at national, State, and local levels.

NIH is responsible for the nationwide infrastructure for animals in research, which includes not only laboratory animals, but also the resources and facilities required to ensure their availability, appropriate use, and humane care. The purpose of Evaluation of Laboratory Animal Use, Facilities and Resources--Phase II is to provide NIH and other government agencies with information and objective data to inform the current national discussion--involving the press, animal rights activists, scientists, and others--about laboratory animal use.

Congress requires NIH to report annually on clinical research it is sponsoring for rare diseases. Development of a Database for NIH-Supported Rare Disease Research will establish a data base of NIH-sponsored rare disease clinical research. The Oak Ridge Institute for Science and Education will provide the instrument for NIH to determine the presence of existing data bases and the nature and extent of data on rare disease studies funded by the NIH. The contractor will review the completed instruments and will develop and provide recommendations on estimated costs and on the best ways to make the data base accessible to the biomedical research community, practicing physicians and other health professionals, and the public.

New Directions for Evaluation

NIH will continue to engage in a wide variety of evaluation activities. Priority setting for future NIH evaluation activities includes input from a number of sources including the HHS Strategic Plan, the NIH Government Performance and Results Act Performance Plan, and the NIH Strategic Plan--all in the developmental phase; the NIH Director's Areas of Emphasis; the Administration's High-Priority Areas; recommendations of the NIH IC Directors; and the recommendations of the EPOC. As a result, NIH will give priority funding to the following evaluation areas of study.

NIH evaluation studies provide a rational basis for managerial decision making and responding to public concerns for accountability in government. Additionally, it is through such studies that the NIH is able to determine progress in meeting its scientific objectives, strengthening research and administrative activities, and contributing to the mission of NIH to sponsor and conduct research that leads to better health for all Americans.

Office of the Assistant Secretary for Planning and Evaluation

MISSION: To provide analytical support and advice to the Secretary on policy development and to assist the Secretary with the development and coordination of Departmentwide program planning and evaluation activities.

Evaluation Program

The Office of the Assistant Secretary for Planning and Evaluation (ASPE) functions as a principal advisor to the Secretary on policy development and, in this capacity, conducts a variety of evaluation and policy research studies on issues of national importance. ASPE is also responsible for Departmentwide coordination of legislative, planning, and evaluation activities. In its evaluation coordination role, ASPE has the following tasks:

Through the departmental evaluation planning process, ASPE has the capacity to identify cross-cutting program or policy issues of particular concern to the Secretary and specific program and policy areas not covered by the HHS agency evaluation plans. In these instances, ASPE initiates evaluations or collaborates with the agencies to conduct evaluations or policy assessments. For example, in recent years ASPE has initiated projects to develop cost estimates for health financing issues in general, and specifically for the Medicare and Medicaid programs; the effects of managed care expansion on public health infrastructure; welfare-to-work approaches; long-term care alternatives; and studies evaluating alternative services for children at risk of harm from drug abuse, crime, child abuse, and other pathologies.

Another continuing ASPE evaluation objective is to support and promote the development and improvement of data bases that HHS agencies and ASPE use to evaluate health care programs and health trends. For example, ASPE has been the major initiator on collaboration with the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) of the first comprehensive survey of people with disabilities in the United States. The first component of these new data was completed in FY 1996, and national prevalence data on disability are now available. ASPE provides support to the HHS Data Council, which is charged with integrating key national surveys, such as linking health status indicators with indicators of well-being. The Department needs more comprehensive data sources to assess anticipated transformations in health and human services.

Finally, ASPE uses evaluation funds to promote effective use of evaluation-generated information in program management and policy making. The latter is accomplished through the dissemination of evaluation findings and other activities, such as providing technical assistance to agencies in the development of performance measures.

Summary of Fiscal Year 1996 Evaluations

During FY 1996, ASPE completed a wide range of studies and reports on a number of issues, providing information useful to the Secretary and the HHS divisions for purposes of program planning and budget and legislative development.

Health Policy

Disability, Aging, and Long-Term Care Policy

Human Services Policy

Special Populations

In addition, ASPE completed two evaluation projects during FY 1996 that focused on the health needs of special populations. The first project was an evaluation design effort with the Office of Minority Health in the Office of Public Health and Science, titled Family and Community Violence Prevention Program: Technical Assistance in Program Evaluation and Capacity Building Assessment. The project produced a design for the Family and Community Violence Prevention Program, created by the Male Minority Consortium, a group of 19 historically black colleges and universities (HBCU). The report recommends several evaluation strategies that individual HBCU's can employ to assess the program, such as measuring attitudes and beliefs about violence, identifying communication channels and influences, and measuring community participation.

The second project was an effort to synthesize knowledge about the demography of American Indian and Alaska Native populations, with a focus on the major health problems they face and their use of health care services. The report, Changing Numbers, Changing Needs: American Indian Demography and Public Health, documents the difficulties in tracing demographic and public health trends for Native American populations. The report synthesizes data on population growth since the turn of the century, including information on fertility rates; reduction of infant mortality; persistence of high death rates for American Indian youths; declines in infectious diseases; and increases in rates of chronic disease, injuries, and alcohol and drug abuse. One analysis presented in the report showed that although IHS facilities are well suited to serve rural Native American population, problems continue with adequate access to care in rural areas and sufficient levels of budgeted resources.

Evaluations in Progress

Health Policy

Disability, Aging, and Long-Term Care Policy

Human Services Policy

In addition, human services policy assessments are under way to examine child welfare and domestic violence policies, the health and mental health of immigrant children, and factors in the growth and decline of AFDC caseloads.

New Directions for Evaluation

In upcoming years, ASPE will pursue the following evaluation priorities.

Impact of Program Transformation

The public health system and public health programs supported by HHS are an essential part of the health care safety net for the uninsured and are a vital element in protecting the health of all Americans. An increasing challenge for HHS agencies is to understand how health care system changes, such as managed care, interact with the dramatic changes taking place in welfare policies to affect the public health system, public health programs, and the clients those programs serve. In future studies, ASPE will compliment the efforts of the CDC, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Services Administration by evaluating how health and welfare reforms create new challenges and responsibilities for the public health system and programs.

Managed Care and Disability

ASPE will continue to support evaluations to determine the effect of managed care on individuals with disabilities who have both health and long-term care needs. As mentioned above, ASPE, in collaboration with PHS and other HHS agencies, initiated a series of studies to identify and understand how State and community health care reform efforts are affecting people with disabilities. New studies will continue to examine the impact of selected State and community managed care initiatives on people with disabilities, including how such arrangements affect access to needed services, health status, well-being, and satisfaction. Investigations will also focus on developing better outcome indicators of health care quality for elderly persons with physical and cognitive impairments, including individuals with Alzheimer's disease and other dementias. In addition, a collaborative evaluation effort will be initiated with PHS and HCFA to investigate the effectiveness of new initiatives to integrate health and long-term care services.

Impact of Welfare Reform

ASPE will be initiating new studies in upcoming years to evaluate the combined changes taking place in health care delivery systems and in income supports for low-income children and families who often have special needs. One issue that will be studied is how to help substance abusers and victims of domestic violence whose entitlements and access to services will change under the terms of new welfare reform legislation. Under the Personal Responsibility and Work Opportunity Reconciliation Act, welfare recipients generally will be required to work to receive benefits and will face overall time limits on welfare receipt. In the past, many clients identified as substance abusers or victims of domestic violence were not required to participate in work activities. While some of these clients will be exempted under the new law, others must enter the workforce. Case managers need better tools to assess clients' barriers to sustaining employment and to assist these clients in addressing those barriers.

Other ASPE efforts to study the combined effects of changes in health care and income support policies on the public health system and its clients will focus on developing better State and national data on outcomes and the impact of the changes on the health and well-being of children and youth. Studies that address teen pregnancy prevention will build on work already undertaken and will examine how communities are addressing this issue as required in the new welfare law.

Quality-Related Studies

A major goal of the ASPE evaluation program, in relationship to HHS's ongoing responsibilities in the area of consumer protection and health quality standards, is both to understand the measurement of quality of care issues in health plans and providers and to improve the public availability and the comparability of such information. Working in conjunction with HCFA's Bureau of Health Standards and Quality, the Agency for Health Care Policy and Research, and other related PHS agencies, ASPE will develop projects to better measure health outcomes, relate health outcomes data to critical process of care data, evaluate the feasibility of developing new outcomes-based measures as part of administrative monitoring systems, and provide comparative-based health information to health consumers.

Improving Evaluation Data and Analytic Capability

HHS has taken a number of steps to strengthen its capacity in the data policy area and to work more effectively in collaborative data efforts with the health industry, the research community, and State and local governments. In the future, ASPE, working with the HHS Data Council, expects to initiate projects to support (1) development of State data strategies to monitor the impact of health and welfare transformations and to support evaluation of public health programs; (2) development of health data standards to support evaluation and monitoring in health care and public health programs; and (3) development and evaluation of HHS-wide information-privacy policy. These projects are largely responsive to new data policy requirements that the Kennedy-Kassebaum law places on HHS.

Office of Public Health and Science

MISSION: To provide advice on public health and science to the Secretary of Health and Human Services, to provide executive direction to program offices within OPHS, and, at the direction of the Secretary, to coordinate cross-cutting Public Health and Science initiatives in the Department.

Evaluation Program

The Office of Public Health and Science (OPHS) within the Department of Health and Human Services (HHS) provides advice, policy and program coordination, and leadership in the implementation, management, and development of activities related to public health and science, as directed by the Secretary. OPHS provides advice to ensure that HHS conducts broad-based public health assessments designed to better define public health problems and solutions to those problems. It assists other components of HHS in anticipating future public health issues and problems and provides assistance to ensure that HHS designs and implements appropriate approaches, interventions, and evaluations that will maintain, sustain, and improve the health of the Nation. OPHS provides a focus for leadership on matters including recommendations for policy on population-based public health and science and, at the Secretary's direction, leads or coordinates initiatives that cut across agencies and operating divisions. In addition, it communicates and interacts, on behalf of the Secretary, with national and international professional and constituency organizations on matters of public health and science. It also provides guidance and coordination across the Department on international results and domestic refugee health issues, and serves as the focal point for senior staff support in the governance of health agencies of the United Nations system.

In keeping with its newly defined role within the Department, OPHS has specifically sought to develop an evaluation plan that avoids duplication of efforts that might more appropriately and effectively be undertaken by the operating divisions of HHS or by the Office of the Assistant Secretary for Planning and Evaluation (ASPE). Thus, the direction of the FY 1997 evaluation strategy for OPHS is toward public health and science issues that cut across multiple interests of the operating divisions and that require a coordinated approach to achieve the most effective results. In addition, OPHS commits itself to seeking to carry out every project proposed as part of this year's strategy in collaboration with relevant operating divisions.

As to its specific responsibilities, OPHS conducts evaluations requested of the Secretary by Congress that are most appropriately managed by staff with medical or public health sciences credentials, and that cannot be assigned to an operating division. Also, evaluations are conducted to support the Assistant Secretary for Health in his or her role as senior advisor for public health and science to the Secretary. This role includes the responsibility to "assist the Secretary in developing a policy agenda for the Department to address major population-based public health, prevention and science issues" and to provide "leadership and a focus for coordination of population-based health, clinical preventive services and science initiatives that cut across operating divisions." In addition, OPHS conducts evaluations specific to the needs of the program offices located within OPHS, such as Women's Health, Minority Health, Disease Prevention and Health Promotion, International and Refugee Health, and Emergency Preparedness.

Summary of Fiscal Year 1996 Evaluations

In FY 1996, OPHS completed four evaluations in an effort to better inform policy decisions throughout the Public Health Service (PHS). Studies completed this year focus on performance and accountability of the public health and science communities and include such topics as improved methodologies for cost-effectiveness analysis and quantification of State public health expenditures, an examination of refugee health care issues, and the impact of research misconduct investigations. As illustrated below, OPHS efforts cut across a variety of PHS program areas.

In an effort to study and learn from past experiences, the cost-effectiveness analysis (CEA) report provides an assessment of the current state-of-the-science of CEA methodology and makes recommendations about ways to improve the quality, comparability, and utility of CEA's. CEA is a powerful tool for evaluating which strategies best serve programmatic and financial objectives. Unresolved methodological issues are discussed in the context of factors that limit the policy relevance of existing CEA's. The CEA report is described in more detail in Chapter II.

A second methodological report, Measuring Expenditures for Essential Public Health Services, was completed on quantification of State public health expenditures. Working with State and local public health, mental health, substance abuse, and environmental agencies in nine States and with Federal PHS agencies, a methodology was developed and tested for estimating investments in 10 essential public health service areas. For all nine participating States, the total expenditure for essential public health services was $8.8 billion in 1994-95, of which $2.7 billion is population based. Estimates of public health expenditures are provided for agencies within the States and by service areas. In addition to estimating the relative investment in public health in the United States, the report lays the groundwork for a system to track these expenditures over time, across agencies, and across levels of Government. The resulting financial data can be related public health outcomes, infrastructure, and workforce measurements. An article about this study was published in Morbidity and Mortality Weekly Report on February 21, 1997.

A report on the health needs of newly arriving refugees evaluated the health assessment and follow-up care available to refugees, Cuban and Haitian entrants, and Amerasian immigrants from Vietnam during the first 8 months following their arrival in the United States. During this 8-month period, the Federal Government provides funding for health care coverage to refugees to prevent the spread of health conditions that could affect the public health and to identify health conditions that could impede effective refugee resettlement. The findings indicate areas of success, as well as areas needing improvement. For example, the flexibility of Federal funding has enabled States to fill gaps in their refugee health programs. In addition, statewide infrastructure for refugee health care has been developed in States that contract with local providers to deliver health-screening services. Concerns are raised about the accuracy and completeness of screening conducted outside of refugee-specific clinics, the reporting of refugee health screening results to the Centers for Disease Control and Prevention, and the availability of follow-up care to refugees.

Scientific misconduct is a topic of great interest to the public health and science communities. In its report on the consequences of being accused of research misconduct, the Office of Research Integrity (ORI) examined the impact of misconduct investigations on exonerated researchers. About 70 percent of all cases of alleged scientific misconduct that come to the attention of ORI result in exoneration. Yet little was known about the adverse consequences for the accused and the extent to which institutions comply with confidentiality requirements. The findings raise questions about the confidentiality of ongoing investigations. In a survey of 54 individuals who were accused of scientific misconduct and exonerated (prior to 1995), 60 percent reported one or more negative consequences of being accused of scientific misconduct. Of these, 90 percent indicated that the negative actions began during the inquiry or investigation and 65 percent reported that these actions continued after they had been exonerated. Yet only 39 percent viewed the impact of accusation on their careers as negative; 39 percent believed there was a continuing stigma attached to having been accused of misconduct. A similar 38 percent of the respondents were dissatisfied with the efforts of their institutions to restore their reputations.

Evaluations in Progress

In reviewing evaluation projects for FY 1996, OPHS considered the following priority areas: congressional mandates, cross-departmental initiatives, OPHS strategic plan-related initiatives, program improvements, and the Government Performance and Results Act (GPRA). OPHS selected 17 program and policy evaluations for funding this year, which are described below.

The Commission on Dietary Supplement Labels, appointed by the President, is evaluating factors relevant to Food and Drug Administration regulation and possible legislation of label claims and statements for dietary supplements, including health claims as requested by Congress. A second nutritional study, undertaken by the National Academy of Sciences, is evaluating human nutrient requirements. The study will provide reference intakes, guidance about these values for clinical and public health use, and a listing of research needs.

An evaluation of the Cooperative Agreements for Demonstration Projects for Capacity Building at Historically Black Colleges and Universities (HBCU's) is under way. The setting will examine the extent to which the overall program and individual projects have resulted in the establishment of offices of sponsored programs and the adoption of uniform processes in participating schools. The evaluation will also assess how well the program has achieved increased funding for health-related research and training at the institutions and how effectively it has enhanced current research, training, and services.

The OPHS evaluation priorities related to strategic planning initiatives will focus on several areas. First is the organization of the Healthy People 2000 objectives. To promote an integrated public health message, OPHS is consulting a broad range of members of the Healthy People 2000 Consortium and using focus groups to evaluate the basic framework of national health goals and objectives in preparing for the Healthy People 2010 Plan. The study will collect insights on the current functions of the objectives framework and explore opportunities for making them more relevant to the Healthy People 2000 Consortium members, State and local agencies, managed care industry representatives, and Fortune 500 major purchasers of health care plans.

School health programs, both comprehensive and categorical, continue to be developed and implemented throughout the Nation. OPHS has funded a study to identify evaluations of school health programs and make available an updated compilation of methodologically sound studies and their findings to assist school boards, administrators, health personnel, and health educators trying to maximize limited resources for effective health programs.

OPHS will continue to expand efforts to improve nationally available data on the public health infrastructure, focusing on local public health capacity and workforce issues. The results will provide local health officials and planners with a validated instrument for estimating the level of support for essential public health functions. This local study of expenditures represents the community analog to the State study funded in FY 1996.

In the area of health data and the environment and in continuance of support for public health infrastructure revitalization, OPHS funded development of two data-tracking systems, one related to sentinel public health indicators, health outcomes, levels of health risks, and the health protection infrastructure; and the second on State and local environmental health data needs and sources of State and local environmental information. OPHS also funded an assessment of health plan involvement in community-based initiatives and a survey of clinicians to assess the level of provision of and the importance placed on preventive clinical services by primary care providers,

OPHS supports several projects to assist in improving program operations and management. These include an evaluation of a new model of coordinating and integrating HIV-prevention messages and primary care in high risk populations, an evaluation of the Minority Health Resource Center, and the assessment of the Adolescent Family Life Program.

The implementation of the GPRA of 1992 is a priority for OPHS. The development of performance measures for public health programs will be crucial for program planning, budgeting, and legislative development. OPHS, in collaboration with the Office of the Assistant Secretary for Planning and Evaluation, has targeted efforts in three program areas to develop these measures. First, it is supporting completion of the consultation begun in FY1995 with State and local health officials concerning the development of performance measurement systems that can be used to improve accountability for expenditure of Federal funds. OPHS will assist States and local governments in determining the impact Federal programs are having on improving the health status of Americans. OPHS will also discern the extent to which States and selected counties and cities have current data available to measure their own State year 2000 objectives and selected national objectives.

Two communication studies are also under way. The first focuses on the design and evaluation of interactive communication applications for consumer health information. A second study examines the dissemination of public health information from PHS agencies.

Finally, the Office of Minority Health is examining the efficiency and effectiveness of its Bilingual/Bicultural Service Demonstration Grant Program, which is intended to build the capacity of community-based organizations to address access to health services for limited-English-speaking minority populations.

New Directions for Evaluation

The next few years will continue to be a time of enormous transformation for this Nation's health care system. The need to manage skyrocketing health care costs and rein in the Federal budget deficit--while trying to address the health needs of over 40 million uninsured Americans and a general population that is becoming increasingly aged as well as linguistically and culturally diverse--presents enormous challenges to HHS, OPHS, and our partners in the public health community.

The shifting emphasis on managed care presents new opportunities coupled with new dilemmas regarding how best to ensure that, in the quest to manage the cost of care, overall quality of care is not unduly compromised. It raises new questions of how to ensure a workforce that is properly trained and fully capable of performing the essential services of public health to increasingly diverse populations in this dynamic health care environment. Furthermore, transformations in the health care and public health arena necessitate the monitoring and assessment (and the data systems to do so) of the effects and impacts of these changes on the financing, organization, and availability of population- and clinic-based preventive services and medical treatment.

OPHS has given highest priority in its FY 1997 strategic plan and evaluation efforts to addressing these issues. The FY 1997 OPHS strategic plan emphasizes the need for a strong foundation for public health in the 21st century. The priorities focus attention on (1) the information systems and workforce that comprise the Nation's public health infrastructure and that are necessary to effectively provide the essential services of public health; and (2) the impact of managed care arrangements on the resources available for this infrastructure and on the health of all Americans, especially those most vulnerable.

Future OPHS evaluation planning efforts will reflect the OPHS strategic plan, as well as the broader HHS programmatic priorities related to improving the health of all Americans and assessing the effects of health-sector transformation. Planned investigations in support of the public health infrastructure include an assessment of response to health and medical consequences of chemical and biological agent incidents; an evaluation of summary measures of health status; an evaluation of the electronic gateway to consumer health information; analyses of international year 2000 plans to inform the United States effort and the WHO Renewing Health for All strategy; and an examination of outreach efforts and potential uses of Healthy People Objectives for the Year 2010.

Other planned evaluation activities will focus on addressing specific health needs of our most vulnerable populations. These include evaluations of strategies and approaches for addressing the health of racial and ethnic minorities in the United States as compared with the United Kingdom, cultural competence in health care to address issues of measurement and linkages to health and patient outcomes, an inventory of State data on women's health, an inventory and assessment of linguistically and culturally appropriate services in managed care outreach organizations and an assessment of minority consumer experiences with State outreach activities related to Medicaid managed care.

Last, in response to the increased need to measure the performance and effects of public health programs and activities, OPHS will support efforts to enable performance measurement activities among local, State, and Federal health agencies.

Substance Abuse and Mental Health Services Administration

MISSION: To improve the quality and availability of prevention, treatment, and rehabilitation services for substance abuse and mental illness.

Evaluation Program

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to evaluating its overall programs and individual grant projects to assess the effectiveness of prevention, treatment, and rehabilitation approaches and systems of care; the accountability of Federal funds; and the achievement of SAMHSA's programmatic and policy objectives.

To the greatest extent appropriate and feasible, SAMHSA will encourage the use of comparable data elements and instruments across its evaluations in order to work toward a comprehensive evaluation system and to minimize respondent burden.

SAMHSA conducts grant programs under a variety of legislative authorities. These authorities can generally be grouped into two types: (1) services and (2) knowledge development and application (KDA). The evaluation required for a particular grant program is dependent on the type and purpose of the program. SAMHSA will evaluate each of its service programs and provide information to program managers about the accountability of Federal funds. In addition, the evaluations of KDA programs will generate new knowledge to lead the field in the development of policies that improve services. Program and evaluation staff must work together to identify clearly the questions or goals each grant program will address and to propose appropriate evaluation strategies.

The two types of grant programs (service delivery and KDA) represent the two facets of SAMHSA's mission. SAMHSA's leadership in the field depends on the successful interaction of these two facets of its mission. Through evaluation, SAMHSA must identify effective approaches to prevention, treatment, and rehabilitation. Through service delivery funds, SAMHSA must provide incentives to the field to implement effective approaches. Major emphases of SAMHSA's mission are to develop, identify, and disseminate effective strategies and systems for prevention, treatment, and rehabilitation.

SAMHSA is implementing an integrated model of evaluation and planning. Strategic planning identifies priorities, such as managed care, that drive the development of grant programs and evaluations. In compliance with the Government Performance and Results Act (GPRA), SAMHSA is attempting to improve performance by identifying performance goals associated with its strategic plan. The formulation of programmatic and evaluation priorities includes consultation with the SAMHSA and Center Advisory Councils and with other experts in the fields of evaluation and service delivery. Early and continuous coordination of program planning and evaluation design will result in the articulation of program objectives that can be evaluated. Evaluations will show how well the overall grant programs have achieved their objectives, and SAMHSA will translate these results into information that can be used for program and policy development. The strategic planning and policy development processes will then use these results to refine SAMHSA's priorities and objectives.

This evaluation policy will help SAMHSA achieve its goal of continually informing policy and program development with knowledge culled from past performance. In this way SAMHSA can best serve its customers by enhancing the quality of public substance abuse and mental health services.

In compliance with Public Health Service (PHS) guidelines for the technical review of evaluations, SAMHSA has established a standing committee of PHS staff who are evaluation specialists. Representatives of the Office of the Assistant Secretary for Planning and Evaluation serve as ex officio members of the committee. The SAMHSA evaluation officer is the committee chair. The committee does not generally review the evaluation proposals of individual grantees. It does review proposals for broader, more comprehensive evaluations, such as the cross-project evaluations of grant programs.

Evaluation project proposals are generally prepared by SAMHSA program staff in the various Centers. The standing committee reviews each proposal on the following criteria: clarity of evaluation objectives and research questions; appropriateness and feasibility of the specifications for evaluation design and methods; appropriateness of the plans for dissemination of results; and use of previous relevant evaluations and existing program data systems. Each proposal must clearly state the relationship of the evaluation to SAMHSA's overall policies, priorities, and evaluation program.

Summary of Fiscal Year 1996 Evaluations

In FY 1996, SAMHSA completed a report entitled Overview of Addiction Treatment Effectiveness. This document presents an overview of the research literature substantiating the effectiveness of addiction treatment. The report describes specific treatment approaches, settings, components, and services and provides an analysis of the effectiveness of each. It was prepared by conducting comprehensive literature searches, reviewing meta-analyses, examining literature reviews, and reviewing several hundred research articles.

Also during FY 1996, SAMHSA completed a report entitled Employment Outcomes of Indigent Clients Receiving Alcohol and Drug Treatment in Washington State. This report was prepared by researchers at the University of Washington and the Washington State Division of Alcohol and Substance Abuse. It reports results from a project that evaluated substance abuse treatment outcomes for indigent clients served in Washington State. The treatment group included 499 individuals in various treatment modalities. The comparison group included 168 clients who were assessed but did not initiate treatment. Analyses were conducted on employment outcomes, using data obtained from official State employment records. The employment data cover a 12-month period before treatment and an 18-month period after treatment.

The study found that the duration of treatment is an important predictor of employment outcomes. Clients staying in treatment longer experience better outcomes, as do clients who complete treatment. A second finding was that the benefits of treatment, in enhanced earnings, compare favorably with the costs of treatment.

The policy implication of the study is that less treatment may not necessarily be less costly in the long run. Limiting coverage for substance abuse treatment for public clients will reduce short-run treatment costs, but may compromise important benefits of treatment, such as enhanced employment and increased earnings.

Evaluations in Progress

SAMHSA currently has several major evaluations under way in the following general areas: program accountability, knowledge development and application, and managed care.

Program Accountability

SAMHSA conducts evaluations for program accountability in compliance with the GPRA. These evaluations are undertaken to inform program management and help managers refine program operations. This is the primary type of evaluation conducted on SAMHSA's service grant programs. For example, the children's mental health service program has an ongoing evaluation. The evaluation will yield continuous information on program implementation and on outcomes for children and families served. This information will be used for reports to Congress, feedback to grantees, program development, and performance improvement.

Knowledge Development and Application

The primary purpose of SAMHSA's KDA program is to generate new knowledge to lead the field in the development of policies that improve substance abuse and mental health services. For example, evaluation results on substance abuse prevention for high risk youth will allow policymakers to draw inferences about the effectiveness of certain interventions for this population. An evaluation of the program for Access to Community Care and Effective Services and Supports will provide information for the design of ongoing service programs at the Federal, State, and local levels.

The National Treatment Improvement Evaluation Study is a cross-site evaluation study examining the effectiveness of demonstration grants funded by the Center for Substance Abuse Treatment. The purpose of the study is to assess the extent to which treatment enhancements improve substance abuse treatment outcomes over time. Preliminary results from this study provide strong support for the efficacy of substance abuse treatment in reducing levels of substance use, reducing involvement in criminal activities, and increasing employment. The final report will be available in FY 1997.

Managed Care

The Center for Substance Abuse Treatment has initiated an important managed care evaluation to assess the impact of State managed care initiatives on substance abuse treatment in terms of access, cost, and quality. Currently, there is little information at the State, provider, or client levels on the impact of managed care on the provision and outcomes of substance abuse treatment services. Several States will be selected for rigorous, statistical evaluation, which will include measures of costs, access, quality, and treatment outcomes. Results will be used to improve State substance abuse managed care programs and for Federal policy making related to managed care and health care reform.

New Directions for Evaluation

SAMHSA is designing its evaluation activities to guide programmatic and policy decisions. The evaluation activities will complement the SAMHSA and HHS strategic plans and will respond to emerging trends such as managed care.

One SAMHSA evaluation priority is knowledge development and application. SAMHSA's KDA program is designed to answer specific, important, policy-relevant questions. These questions will be designed to provide critical information to improve the Nation's mental health and substance abuse treatment and prevention services. Evaluations of the current KDA program will generate knowledge on such topics as the relative effectiveness of alternative models of managed care for treatment and prevention of substance abuse and mental disorders, the relative effectiveness of alternate models for preventing homelessness among adults with serious mental illnesses, and the efficacy of a brief intervention for marijuana dependence.

Another of SAMHSA's evaluation priorities is to assess the impact of managed care on the availability of services to populations in need, and to develop standards for measuring quality and outcome. SAMHSA's managed care evaluation strategy is designed to leverage important knowledge that directly affects the agency mission. This knowledge will be acquired through focused applied health services research, evaluations, demonstrations, and epidemiological and service capacity studies.

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