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Office of the Assistant Secretary |
Policy Information Center |
In this Chapter, the U.S. Department of Health and Human Services (HHS) highlights evaluations of general interest to the public health, health care services, and human services community and illustrates the diversity of HHS evaluations completed in fiscal year (FY) 1997. Included are summaries of 9 evaluation projects selected by the Evaluation Review Panel--on the basis of criteria identified in Appendix C--and applied to 28 reports nominated by HHS agencies. These criteria are as follows:
The nine studies are organized under three headings: performance measurement or assessment, program management and development, and policy analysis and development. These headings represent the three most common uses of HHS evaluation resources. Performance measurement or assessment is a high priority for HHS agencies as the development, implementation, and refinement of programs are more results oriented in the 1990's and are required under the Government Performance and Results Act (GPRA) of 1993. Program management and development reflects the kind of evaluation projects that program managers initiate to obtain information or data that will help them manage a program efficiently and ensure successful results. Policy analysis and development includes the evaluation projects conducted by HHS agencies to examine the impact of alternative policies, either in the past or in the future, on the future direction of HHS programs or services.
Each summary includes a brief abstract; a description of the study, including its purpose, background, methods, findings, and use of results; the names of any publications that resulted; and the name and phone number of the HHS official to contact for additional information.
Chapter II Divisions
Performance Measurement and Assessment
LEAP: Final Report on Ohio's Welfare Initiative to Improve School Attendance Among Teenage Parents
National Treatment Improvement Evaluation Study: Final Report
Program Management and Development
Syphilis in the South: A Case Study Assessment in Eight Southern Communities
Stakeholders Revisit Healthy People 2000 to Maximize the Impact for 2010
Policy Analysis and Development
Impact of the Medicare Fee Schedule on Teaching Physicians
Informal and Formal Kinship Care
PERFORMANCE MEASUREMENT AND ASSESSMENT
LEAP: Final Report on Ohio's Welfare Initiative to Improve School Attendance Among Teenage Parents
Highlights
The goal of Ohio's Learning, Earning, and Parenting (LEAP) Program was to use financial incentives to increase the proportion of pregnant teenagers and teen parents on welfare who graduate from high school or receive a General Educational Development (GED) certificate, find jobs, and ultimately achieve self-sufficiency. The teens are recipients of cash assistance, formerly under the Aid to Families with Dependent Children (AFDC) program and more recently under the Temporary Assistance for Needy Families program. This report is the final product in a multi-year evaluation of LEAP. Immediate goals were to induce dropouts to return to high school or to enroll in GED programs, and to promote better attendance among those already enrolled when they were called into LEAP. These short-term goals were accomplished--statistically significant increases in school enrollment and attendance were observed. Longer-term goals were to increase the rate of high school graduation, GED attainment, and teen employment, and to reduce welfare payments. These long-term goals were only partly successful. The LEAP program did not increase high school completion rates except for teens who were initially enrolled in school in the city of Cleveland. LEAP increased employment among those initially enrolled in school but not among those not initially enrolled. There were initial impacts on earnings for the initially enrolled group, but earnings were matched by the control group after two years. Welfare payments fell by more than the cost of the LEAP Program. The evaluation of LEAP is timely in light of new changes to national welfare law, which increases emphasis on school attendance by those who have not completed high school (or its equivalent) and on more employment-oriented activities for teens and other welfare recipients.
Purpose
This study concluded a multi-year evaluation of LEAP's effect on school enrollment, attendance, employment, earnings, and reduction of dependency on welfare among pregnant teenagers and teen parents who receive AFDC. This report is based on a 4-year followup that traced the cumulative impact of LEAP on these school- and work-related outcomes in Ohio.
Background
Families started by women who first gave birth as teenagers account for approximately 50 percent of all long-term AFDC recipients. The enactment of the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 replaced the entitlement to AFDC with block grants to States. Under the law, unmarried custodial minor parents who have not graduated from high school or received a GED certificate may not receive federally funded welfare assistance unless they attend high school or a program that prepares them to earn an alternative education or training credential. Prior to its enactment, however, many States had already implemented some form of school requirement for teen parents on welfare. The LEAP Program in Ohio, initiated in 1989, was one of the first to mandate school attendance for the entire teen parent welfare caseload and to include a rigorous program evaluation. It was hoped that LEAP's direct effects on enrollment and attendance would translate into improvement in other outcomes, such as greater progress in school, more receipt of high school diplomas and GEDs, increased employment, and reduced welfare dependence.
Methods
The evaluation of LEAP uses a random assignment research design and multiple data sources. For this report, 12 Ohio counties were sampled to provide data on 4,151 teens, of whom 3,479 were randomly assigned as program group members, and 672 were assigned as control group members. Teens in the program group who met LEAP's requirements had their welfare checks increased by $62 for school enrollment and an additional $62 for each month of acceptable school attendance. Teens who did not comply had $62 deducted from their welfare grant every month until they complied with program rules. During 1992, a teen living on her own with one child was eligible for a monthly AFDC grant of $274--the bonus or sanction of $62 was a significant amount.
A survey was administered to 1,188 teens 1 year after entry to assess school enrollment status and experience with LEAP. Selected county case files were reviewed to study LEAP's implementation and the bonus/sanction process. A survey of 913 teens in 7 counties was made 3 years after random assignment to measure education, employment, and welfare outcomes. Data on employment earnings and welfare dependency were drawn from unemployment and AFDC records, respectively.
Findings
A statistically significant increase in teen parent enrollment and attendance in school or in a GED program was achieved. Statistically significant increases were also observed in the completion of the 9th, 10th, and 11th grades. However, the longer-term goal of high school completion or its equivalent was not achieved for the full sample. The program increased GED certificate receipt, but not high school graduation rates, among the subgroup of teens who were enrolled in school when they entered LEAP. No statistically significant differences were found in GED certificate receipt or high school graduation among teens who were not enrolled in school when they entered LEAP. High school graduation rates increased only in Cleveland, which may be attributable to an earlier and enhanced LEAP pilot program in the city Cleveland.
Both the program and control groups of teens experienced substantial growth in employment rates and earnings during the 4-year followup period, with quarterly employment rates increasing from about 15 percent to about 40 percent. The LEAP program increased employment for initially enrolled teens, but not for their control group counterparts during the followup years. Earnings of the initially-enrolled students also increased during the first 2 years of followup, but were ultimately matched by earnings in the control group of teens. Rates of AFDC receipt remained high throughout the followup period (more than 60 percent of all teens were on welfare), but declined from 100 percent at the time of random assignment to 60.9 percent in the last quarter of the fourth year. Program group members were somewhat less likely to receive AFDC than were control group members in at least 1 month in most quarters. LEAP reduced both the number of teens receiving AFDC and the amount of AFDC received, with more of the reduction found among those who were initially enrolled in school. Although LEAP was deemed cost-effective, the size and duration of the effects on employment and AFDC receipts may have been suppressed by LEAP's disappointing effect on school completion.
Recommendations for improved policy and program design focused on ensuring case management and well-designed management information systems, improving teens' understanding of the rules and expectations, intervening early to prevent teens from dropping out of school, addressing teens' reservations about school attendance, rewarding academic progress and school completion, and integrating more work opportunities into the program.
Use of Results
This study provides a useful State model for operating new national welfare rules. It suggests that such programs may need to be complemented by incentives to reward academic progress and school completion in addition to school enrollment and attendance. The education message, however, may need to be combined with more employment-oriented activities in order to meet the more work-oriented expectations and time-limited benefit rules that were mandated in 1996. Programs may be more effective if they take into account the specific needs of distinct groups of teen parents. What works for a 17-year-old who is still in school and can complete within 1 year may not work for a 19-year-old who has been out of school for 3 years and has two children. Providing more tailored services and incentives that are meaningful to specific groups may be necessary to improve upon the outcomes observed under LEAP and to attain improvements in the longer term outcomes for these young families.
AGENCY SPONSOR: Administration for Children and Families, Office of Planning, Research, and Evaluation
FEDERAL CONTACT: Nancy Campbell
PHONE NUMBER: (202) 401-5760
PIC ID: 6668
PERFORMER ORGANIZATION: Manpower Demonstration Research Corporation, New York, NY
National Treatment Improvement Evaluation Study: Final Report
Highlights
The congressionally mandated 5-year study National Treatment Improvement Evaluation Study (NTIES) examined the impact of three federally-sponsored drug and alcohol treatment demonstration programs. The study found that the demonstration programs significantly reduced drug and alcohol use, and that treatment had lasting benefits. Clients reported increases in employment and income, improvements in mental and physical health, decreases in criminal activities and homelessness, and modification of sexually-risky behavior.
Purpose
In addition to profiling
the services, programs, and clients involved in three demonstration programs
funded by the Center for Substance Abuse Treatment (CSAT), the study was
designed to address the effects of comprehensive treatment on client access to
services and on patient outcomes. Lessons learned about the implementation and
cost of delivering comprehensive drug treatment services were to be
documented.
Background
A comprehensive treatment model assumes that positive and well-sustained outcomes occur when substance abuse treatment systems draw from a full array of medical and rehabilitative services. These services can include primary medical care, psychiatric services, health education, HIV/AIDS counseling, psychological counseling, legal assistance, social and welfare services, spiritual counseling, job training, educational counseling, social activities, and continuing care services. To demonstrate the value of such a comprehensive substance abuse treatment model, CSAT initiated three major demonstration projects to enhance treatment services by building on an existing infrastructure for substance abuse treatment. The three demonstration programs were Cooperative Agreement for Drug Abuse Treatment in Large Cities, Model Comprehensive Treatment Programs for Critical Populations (with special components for adolescent/juvenile justice and public housing), and Model Drug Abuse Treatment Programs for Criminal Justice Populations (for nonincarcerated offenders and those in correctional settings). Recipients of demonstration funding were required to initiate some form of local self-study and to participate in a multisite evaluation (the NTIES) to capture and disseminate lessons learned from these programs.
Methods
NTIES employed a two-level study design to assess the effectiveness of the demonstration programs and a comprehensive treatment approach. The first level was a multiphase survey that addressed treatment unit administration, including treatment orientation, size, budget, and staffing distribution for each of the demonstration programs. The second level involved collecting data on clinical outcomes from clients enrolled in drug treatment at a subsample of the funded sites. This level included three waves of longitudinal data collection. Clients were interviewed at admission to treatment, when they left treatment, and at a followup 1 year after treatment. A total of 6,593 clients at 78 service delivery units were enrolled in the clinical outcomes study. More than 82 percent of the recruited sample completed the followup interview. The outcomes analyses focused on the 4,411 clients for whom followup data were available, along with either an interview at treatment exit or a patient records abstract form.
NTIES, like many other major research surveys, relied primarily on self-reported data. To validate self-reports regarding illicit drug use and arrests, the study also collected data on urine sample drug testing and arrest records. A pre- and post-panel design was used. This method compares behaviors or other individual characteristics in the same research subjects, measured in similar ways before and after intervention. The findings are expressed as percentage of the occurrence of a behavior or circumstances in the NTIES population during clearly defined intervals.
Findings
The study generally found significant reductions in substance abuse during and immediately following treatment. Clients served by the demonstration programs were able to reduce their drug use by about 50 percent for as long as 1 year after leaving treatment. The NTIES data indicate that substance abuse treatment can play a major role in crime reduction. Respondents reported significant decreases in multiple indicators of criminal involvement. The study found that self-reported outcome data on arrests were similar to what might be seen if official records were used, especially for clients interviewed in the community rather than in jails or prisons.
NTIES also explored whether specific patient or treatment unit characteristics could explain variations in pre- and post-treatment outcomes. It found that drug and alcohol use, criminal activity, and employment outcomes were measurably better among individuals who completed their treatment, received more intensive treatment, and were treated longer. The results showed that the length of stay varied across gender, race and ethnicity, and age groups within each type of treatment.
Nearly all clients were involved in the development of their own treatment plans. About 38 percent of the clients said that they received HIV tests, 57 percent received TB tests, and 72 percent received AIDS prevention classes or counseling. Although almost half of the clients needed legal or housing services, only 10 percent were receiving these services. The multivariate analysis showed a significant relationship between the duration of services provided and client satisfaction with the treatment program.
Treatment was determined to be less costly than incarceration. Treatment costs ranged from $1,800 to almost $6,800 per client, while the American Correctional Association estimates the annual cost of incarceration at $18,330.
Use of Results
The study documents that comprehensive and focused substance abuse treatment can make a difference in patient outcomes. The evidence is compelling that the nature and duration of treatment has a positive impact on clinical and employment outcomes and on rates of crime and incarceration. The lower cost of substance abuse treatment (compared to that of incarceration) could have significant implications for the allocation of resources among competing public program priorities.
AGENCY SPONSOR: Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment
FEDERAL CONTACT: Ron Smith
PHONE NUMBER: (301) 443-7730
PIC ID: 5346.1
PERFORMER ORGANIZATION: National Opinion Research Center (NORC), Chicago, IL; and Research Triangle Park, Chapel Hill, NC
PROGRAM MANAGEMENT AND DEVELOPMENT
Self-Sufficiency Project Implementation Manual: Lessons Learned from Eight Years of Office of Community Services Demonstration Partnership Programs
Highlights
This manual summarizes lessons learned during eight years of the Demonstration Partnership Program (DPP) projects. DPP has been developing innovative approaches toward increasing the self-sufficiency of the poor, testing and evaluating these approaches, and encouraging their replication through dissemination of project results and findings. The DPP projects were designed to strengthen the ability of grantees to integrate, coordinate, and redirect activities through community partnerships that promote maximum self-sufficiency among low-income individuals and families who rely on or who are at risk of relying on public assistance. These projects were divided into five program areas and project types: (1) case management, (2) micro-enterprise development, (3) minority males, (4) homelessness, and (5) youth at risk . Generic models for establishing effective community-based programs are presented, and materials for program evaluation are elaborated. For each of the five areas, general and specific lessons learned are presented. A project implementation manual was designed as a step-by-step guide to the successful design and implementation of Self-Sufficiency Projects by Community Action Agencies (CAAs), community-based organizations, and local community program planners.
Purpose
The DPP was designed to permit CAAs to implement and assess innovative approaches toward increasing the self-sufficiency of the poor, including individuals and families who rely on, or are at risk of relying on, public assistance. The purpose of the Self-Sufficiency Project Implementation Manual was to disseminate evaluation findings and information about best practices in the DPP in order to guide and facilitate the future development of each of the five types of self-sufficiency projects supported by the program.
Background
CAAs have been the principal field organizations in the war on poverty for three decades. Since 1981, they have been the primary recipients of Community Services Block Grant funds, dealing with the problems of poverty and attempting to bring poor people up to decent standards of living in economically healthy communities. With the advent of funding for DPP in 1986, CAAs were encouraged by the Congress to add a new dimension to their activities by forming partnerships with public and private entities in their communities and seeking innovative approaches to community revitalization and the problems of poverty. Avoidance of dependency, development of new ways to improve the capabilities of the poor, and overcoming the barriers to workforce entry were central values of the DPP projects. The CAAs have typically served for many years as successful advocates for the poor, forging special bonds with poor people in their communities. As a result of these bonds, CAAs serve as important generators of innovative ideas. The linkage of CAAs with the DPP is intended to build on these special bonds and innovative ideas, and to join them with community partners to develop and experiment with new ways of increasing the self-sufficiency of the poor.
Methods
Development of the implementation manual involved three steps. First, "best practices" were identified by Project Directors and Project Evaluators at a 1994 DPP Reporting Out Conference. These individuals, who were involved in projects funded in 1991 and concluded in 1993, were asked to reflect on their experiences. The evaluators then conducted a more in-depth assessment of what had been learned by the Office of Community Services (OCS) from these projects. In the second step, five team leaders reviewed DPP monographs for each of the five program areas and project types (case management, micro-enterprise development, minority males, homelessness, and youth at risk). The team leaders used quantitative and qualitative information to identify lessons learned and to articulate logic models based on project results and evaluation findings for each program area. In the third step, intensive inputs were obtained from small panels made up of Project Directors and Project Evaluators. These individuals were then convened in focus groups to review and discuss concepts. Team leaders then modified the lessons learned and the logic model based on the discussion. A draft implementation manual was reviewed by experts, project staff, and OCS/DPP personnel.
The results of the study are presented as "lessons learned" in each of the five program and project areas, as well as general lessons that cut across different projects. The Implementation Manual is intended as a brief, step-by-step guide to successful design and implementation of DPP projects. The manual is one of a series of publications developed by OCS to provide technical assistance to CAAs and other grantees. References are provided to other documents in the series for more detailed discussion of evaluation methods, as well as specific project descriptions and evaluation monographs from successful programs.
Findings
The findings indicate that each project is unique because of different environmental factors that affect implementation. Some lessons, however, are generalizable. The findings demonstrate that it is prudent for project directors and managers to learn from prior DPP projects, from literature on promoting self-sufficiency, and from the CAAs' project experiences.
In each of the five project types, the complexities and difficulties of project management are elaborated. This includes basic recommendations, such as the importance of focusing on clients, partner relationships, and staff support. Client focus is essential to ensure that project elements are appropriate for their needs, status, and stage of development toward self-sufficiency. Relationships with partners require particular attention to establish and maintain operational communications and coordinated actions within a noncompetitive environment of cooperation. Staff members are also crucial to success--the selection and professional development of staff should be a well-planned aspect of project management, and communication among staff at all levels cannot be neglected.
Findings also show that each stage of a project requires special attention to ensure success. At startup, emphasis needs to be placed on the physical environment for the safety and convenience of clients and staff. The political environment and issues of competition will require attention, as does the exploration of relationships with other agencies and programs serving the same client group. Although many project managers are tempted to think of evaluation in a post hoc manner, successful evaluation is based, in large part, on careful planning and preparation during the startup phase of a project. Key outcomes need to be framed from the outset in measurable terms.
During the initial operations stage of the project, the design assumptions should be tested and may require adjustment of the model. Client and program operator expectations should be reviewed and tested early in implementation. Organizational management may require special attention as the program structure and staff management issues are being worked out. Findings also point to the importance of beginning to collect evaluation data at this stage.
During the ongoing operations stage, program operators are reminded to be flexible, as past experiences do not necessarily dictate present needs. Staff nurturing becomes increasingly important as the excitement of startup wears off, staff burnout becomes a problem, and additional time is needed to recruit, train, and support volunteers. Evaluation begins to play a greater role as data become available for monitoring and feedback.
At all stages, readers of the Implementation Manual are cautioned not to overlook the complexity of self-sufficiency programs. Logic models are presented for each of the five project types, providing a graphic illustration of the linkages among project assumptions, implementation strategies, and project outcomes, and demonstrating the importance of considering these linkages when managing projects.
Use of Results
Experience-based and empirically supported lessons learned from demonstration projects can be valuable tools for helping to ensure the success of future programs seeking to help low-income families move toward self-sufficiency. The DPP projects offer well grounded insights about the challenges of effective partnerships, about the importance of understanding the logic of the causal relationships between program interventions and expected outcomes and program goals, and about the many complex interactions among program components and program staff. The implementation manual explores the administrative requirements and challenges of successive stages of a project and the critical nature of staff and volunteer training and support, and the profiles of successful self-sufficiency projects attest to the powerful role of evaluation in establishing proper monitoring and feedback loops and quantifiable outcome measures. The manual has already proved to be a valuable tool for staff training in a variety of social agencies, and is being used as a text in at least one university graduate school. It can provide a critical reality check for legislators and policymakers as they strive to design laws and programs that will use scarce resources more effectively to foster self-sufficiency and build sustaining capacity within low-income families and communities.
PUBLICATION: The full report is available from the U.S. Superintendent of Documents, Stock Number 017-090-000-84-4
AGENCY SPONSOR: Administration for Children and Families, Office of Community Services
FEDERAL CONTACT: Richard Saul
PHONE NUMBER: (202) 401-9341
PIC ID: 4336.4
PERFORMER ORGANIZATION: BHM International, Inc., Silver Spring, MD
The Effects of Information Tools and Decision Aids to Help Patient Decision-making about Medical Screening and Treatment
Highlights
This study identified, evaluated, and synthesized research on the effectiveness of tools intended to inform patients about their medical choices, their treatment alternatives, and the risks and benefits of those alternatives. These tools include interactive computer disks, videotapes, audiotapes, brochures, and computer-generated fact sheets to help patients make decisions about medical screening and treatment. The research found that although some studies do point to the promise these tools hold for helping patients and consumers make informed decisions, few controlled and comparative studies have been done. Specifically, only a few treatment choices have been examined, and most studies have looked more at the effects of the tools on patient knowledge/satisfaction and less at the effects of the tools on patient-clinician communication and health behavior/outcomes. Future studies need to be better grounded in theory and draw upon the empirical evidence of other relevant disciplines. Four areas have been identified as priorities for future research. These include an assessment of the effects of informatics tools on a wider range of outcomes, identification of factors that influence patient use of these tools, assessment of the effects of tools on patient/clinician communication, and analysis of the cost effectiveness of different types of patient informatics tools.
Purpose
The purpose of this study was to identify, evaluate, and synthesize research on the effects of informatics tools and decision aids on patient decisions about medical screening and treatment. The study assessed the findings, the quality of the research, recommendations for research design, and priorities for future investigation.
Background
Health information and medical care organizations are investing in the development and dissemination of health informatics tools to help patients and consumers make decisions about screening and treatment. These tools provide treatment- and disease-specific health information to patients, especially when they are facing choices about the ways to treat and manage their health conditions. Information about the risks and benefits of making alternative choices is often included in these tools. An example might be the choice between "watchful waiting" and surgery as responses to low back pain or for benign prostatic hyperplasia. Although patient health informatics tools have the potential to empower patients to make more informed choices, there is limited empirical evidence of their value. Many studies have been small and exploratory, and their research designs have not always employed rigorous controls, adequate sample size, or standardized measurements. Further, it is difficult to ascertain what the tools' effects have been on patient outcomes or health care costs. This study attempted to analyze the literature to see if there were any answers to these questions.
Methods
The study reviews both computerized and noncomputerized informatics tools and decision aids, including such media as interactive computer disks, videotapes, audiotapes, brochures, and computer-generated fact sheets. Experts and researchers in the United States, Canada, and the United Kingdom were consulted to make sure that the study captured as much of the relevant existing research as possible, and that the analysis of it was systematic and comprehensive. Both the published and unpublished literature about the effects of patient informatics tools and decision aids were reviewed, with particular attention paid to findings and the research quality.
Findings
Only 30 controlled studies were identified for evaluation and synthesis in this area; the study presents detailed comparative information on these studies. Some of the more substantive findings suggest that the use of informatics tools can increase patient knowledge of treatment alternatives; further patients report that they like the tools. Some studies report effects on treatment choice, but the number of underlying health conditions and range of tools studied are quite limited. Little is known about the operational and background factors that may influence patient use of informatics tools, such as the requirement for a second visit to use them.
Although patients may tend to ask their physicians more questions as a result of using the tools, their effects on broader patient/clinician communication patterns or on time burdens imposed on clinical staff have not been studied. Some studies have shown that information tools can increase patient adherence to prescribed medical regimen and influence patient preference for nonsurgical interventions. The body of literature would improve if future studies assess a wider range of treatment choices, describe the context of implementation, and document the effects of information tools on patient attitudes, treatment selection, health behaviors and outcomes, and costs.
Much work remains to be done to better understand patient health informatics and to ensure that future tools will be developed and supported on the basis of sound health services research. There are many issues to be addressed. Only a few treatment choices have been examined, and few studies have investigated the effects of tools on patient/clinician communications and health behavior/outcomes. There are no comparative studies of the cost and effectiveness of different types of tools, particularly in the case of computerized versus noncomputerized tools. The studies are of varying methodological quality and most have been exploratory. The cost and clinical significance of informatics tools need to be clearly established by more rigorous research designs, including use of randomized control groups, adequate sample sizes, a wider range of measurable effects, and standard outcome measures.
Future research priorities include 1) identifying factors that promote the use of information tools, 2) assessing the effects of tools on the nature and content of patient/clinician communications and related clinician workload; 3) assessing the effects of tools on health outcomes and health behavior, including quality of life; and 4) comparing and examining the cost effectiveness of different types of patient informatics tools for specified objectives.
Use of Results
This study points to the need to conduct systematic and rigorous research on the use of informatics tools at a time when investments in these tools are being made without sufficient knowledge about their effect on patient decisionmaking, health outcomes, and related costs. Suggestions are made for upgrading the quality of future studies to methodological standards found in health services and clinical research.
By organizing information about the state of our knowledge base, the report is intended to help decisionmakers better understand what is known about consumer/patient health informatics tools. Researchers from all fields can use the report to develop future research projects, and especially to identify specific variables that need further investigation. Practical information on how to reach the developers of some of the existing tools is included as well.
AGENCY SPONSOR: Agency for Health Care Policy and Research, Center for Organization and Delivery Studies
FEDERAL CONTACT: Denise Dougherty
PHONE NUMBER: (301) 594-1321
PIC ID: 6376
PERFORMER ORGANIZATION: Research Triangle Institute, Research Triangle Park, NC
Syphilis in the South: A Case Study Assessment in Eight Southern Communities
Highlights
This project provided a comparative case study of local-level syphilis prevention efforts in eight communities in Alabama, Mississippi, South Carolina, and Tennessee. The project focused on groups perceived to be at high risk of becoming infected with syphilis, the extent to which public health activities target such groups, and identification of factors that affect the reach of services to these groups. African Americans were found to be at greatest risk of syphilis infection. The report highlights the cultural, programmatic, and political barriers that restrict the prevention and control of syphilis and other sexually transmitted diseases (STDs) for those at greatest risk. Cultural barriers include restrictive local norms about public discussion of human sexuality, distrust of the public health system among African Americans, and a low priority of health relative to other issues of poverty in the community. The region also suffers from a shortage of providers and facilities, with inconvenient hours of operation, lack of transportation, and few trained minority staff. Women's access to services is especially limited by the need for child care and transportation, and is complicated by comorbidities (domestic violence and substance abuse). Several innovations in STD control and prevention are described. Recommendations include technical assistance to improve community prevention efforts, gender-sensitive programs that deal with the special problems of women, training/recruitment activities, and improvements in electronic data exchange.
Purpose
The purpose of this study was to compare syphilis prevention efforts in southern communities during an epidemic in the Southern States between 1990 and 1992. Case studies of factors affecting the natural history, epidemiology, and management of syphilis in the South were conducted. Specific objectives included development of an improved understanding of service delivery to persons at high risk of infection with syphilis, discovery of innovative syphilis prevention and control measures planned or implemented in Southern States, and production of recommendations for improving community-level prevention strategies.
Background
The syphilis epidemic in the South during 1990-1992 involved the reemergence of an easily diagnosed and readily treatable STD. Syphilis is a systemic disease with an initial acute stage followed by a long period of latency. Transmission occurs through lesions, normally during sexual contact. These lesions increase the likelihood that HIV transmission will occur as well. Syphilis is treated with penicillin, and it is controlled through activities that involve identification, testing, and treatment of exposed sex partners. Historically, African Americans in the South have suffered a disproportionate burden of early syphilis and congenital syphilis. During 1985-1990, rates of syphilis rose 165 percent in this population, while significantly decreasing for all other races and ethnic groups in this region. African Americans represent 90 percent of all reported cases. There is little empirical evidence to explain why syphilis rates are highest in the South and why the disease primarily affects African Americans in that region.
Methods
Case studies were conducted in eight communities in four States (Alabama, Mississippi, South Carolina, and Tennessee). Sites eligible for the study were communities in ten Southern States identified on the basis of high syphilis morbidity during 1990. Criteria for selecting States and communities included consistently high syphilis rates since 1990, or rates that show a decrease suggestive of successful control activities, and known demographic indicators of high syphilis risk (significant number of African-American residents and proportion of households with incomes below the poverty line). Selected metropolitan areas each were paired with a rural counterpart to allow urban/rural comparison of social contexts and public health activities. Background information about each community was gathered. Week-long site visits were held, with interviews of between 40 and 60 public health providers, other providers, and community representatives at each site. Open-ended interviews focused on who is perceived to be at greatest risk for syphilis transmission/
infection, what institutions are best able to reach these individuals, what barriers stand in the way of reaching at-risk individuals, and innovative ideas or activities that STD prevention programs in other locations might find useful.
Multiple interviewers were used, providing an ongoing check for validity and reliability of data collection. A descriptive case study was prepared for each study site using interview data and information from a background document review. The case studies were sent to leaders in the State and local STD programs to supply any missing information, correct misunderstandings, or add comments.
Findings
This study emphasized that a set of dynamic interactions between distinct social scenarios, institutional situations, and persons in the communities placed certain groups and individuals at greater risk for syphilis infection. Of particular importance in these communities is the overarching issue of poverty. African Americans are the demographic group in the South at greatest risk of syphilis infection. The exchange of sex for drugs, especially when related to crack cocaine use, was considered an important risk behavior. Other risk groups include homeless persons, incarcerated individuals, adolescents, and male homosexuals.
Local health departments are the only community organizations that focus directly on syphilis and STD control and prevention. Other organizations that offer STD diagnosis/treatment provide limited partner notification and contact tracing. Public health agencies tended to assign priority to disease control. Schools were a consistent source of STD prevention messages but the content of these messages was limited by local restrictions on sexually explicit material in health education curricula. Churches were effective in delivering prevention programs but faced significant barriers in any discussion that impinged on issues of human sexuality. Community-based organizations have improved the accessibility of clinical services but have done little to reduce the risk of transmission by sponsoring prevention programs.
Barriers to reaching those at greatest risk include distrust of the public health system among African Americans and a low priority of health relative to other issues of poverty in the community. A long history of mistreatment has led to a general distrust of government in many communities. In the South, prenatal and neonatal care are seen as more pressing health problems. Also, cardiovascular disease, teen pregnancy, diabetes, and cancer are given a higher priority by the African-American community. The region suffers from a shortage of health care providers and facilities, a lack of transportation, and a lack of trained minority staff. Access to services for women are particularly constrained by the need for child care and transportation, inconvenient hours of operation, and the complications caused by comorbidities, such as domestic violence and substance abuse.
Some innovative measures to improve syphilis prevention and control programs have evolved. These include training in screening and referral for agencies that are in contact with persons in high-risk situations, involvement of parents and churches in supporting school health prevention messages, and use of key local community members to serve as local experts and resources on health promotion issues (following the "natural helper" model).
Recommendations include the provision of technical assistance to State and local health departments seeking to improve community involvement in syphilis and other STD prevention efforts. The issue of distrust of the public health system among African Americans needs to be confronted directly, with open dialogue as a necessary condition for improvement. Creative adjustments are needed to overcome barriers to the utilization of clinical facilities, such as more flexible hours of operation and the provision of on-site child care services. STD prevention programs need to take into account the special problems of women. This includes the need to develop child care arrangements, new protocols for handling domestic violence, and strategies for incorporating STD services into the broader array of services offered in women's health clinics. Training in STD prevention/control and cultural competency is encouraged for workers in public health centers, corrections facilities, substance abuse treatment centers, and professional schools. Minority health staff need to be recruited. Finally, enhancements in electronic data exchange and telecommunications support for State and local public health agencies are necessary to improve contact tracing and partner notification.
Use of Results
This study provides a comprehensive overview of problems involved in the prevention and control of syphilis and other STDs in the South. This study has important implications for public health policy development and innovative intervention designs by using an approach that highlights scenarios or conditions for risk of syphilis infection, rather than focusing on the individuals who contracted the disease. The actual and perceived barriers to the use of public health services encompass a wide and complex spectrum of cultural, political, and health system factors. High rates of syphilis in a community are indicative of more than just insufficient public health budgets and point to the need for the integration of disease prevention approaches in the comprehensive planning, policy, and budgeting processes of all organizations providing services to local communities. These results indicate the need to strengthen public health infrastructure and to involve communities and community organizations in the effort to reduce the conditions that place individuals at risk. An action agenda is provided that can help strengthen STD prevention programs and make them more accessible to various at-risk population groups, especially African Americans and women in the southern States. The case studies also provide an overview of innovative ideas that can improve the availability and use of STD-related information and services.
AGENCY SPONSOR: Centers for Disease Control and Prevention, National Center for HIV, STD and TB Prevention
FEDERAL CONTACT: Janelle Dixon
PHONE NUMBER: (404) 639-8344
PIC ID: 6579
PERFORMER ORGANIZATION: Battelle Corporation, Arlington, VA
Stakeholders Revisit Healthy People 2000 to Maximize the Impact for 2010
Highlights
This report presents an assessment by Healthy People 2000 stakeholders on how to restructure the goals and objectives of Healthy People 2000 for the next decade. Healthy People 2000 is a set of national objectives for improving the health of Americans through effective prevention strategies. These objectives form a model framework for results-oriented performance measurements that are relevant to both population- and individual-based health care initiatives. They also serve as benchmarks against which performance can be measured over time. The development of Healthy People 2010 provides an opportunity to reflect on the successes and shortcomings of Healthy People 2000 in achieving these important functions. Healthy People 2000 stakeholders comprise a Steering Committee and Consortium. The Steering Committee consists of representatives from all agencies within the Department of Health and Human Services (HHS). The Consortium consists of representatives from a broad array of 350 organizations, including professional societies, volunteer groups, and trade associations. In addition, State public health, mental health, substance abuse, and environmental agencies are members of the Consortium. Formed in 1987 by the Institute of Medicine, the Consortium is engaged in developing and implementing national prevention objectives.
The report explores new approaches for the development of Healthy People 2010, taking into consideration the many major changes in health care since 1990 and past experience with Healthy People 2000 and the health objectives for 1990. Both the Federal and private sector stakeholders who participated in the focus group review process felt that Healthy People 2010 would benefit from an updated presentation, taking advantage of new information and communication technology and creating a flexible electronic data base on CD-ROM and the Internet, in addition to the reference document. Healthy People 2010 needs to be targeted at an audience broader than the previously targeted public health community.
Purpose
The purpose of this study was to determine whether various stakeholders believed that the Healthy People 2000 document was useful as a framework for results-oriented performance measurement. A review of the successes and shortcomings of Healthy People 2000 in achieving its goals and objectives can facilitate improvement and new approaches in the content, format, and dissemination of its next iteration, Healthy People 2010.
Background
Healthy People 2000 serves as a vision for improving the health of Americans through effective prevention. Its multiple goals, objectives, and priorities were designed to guide health-related decisions and actions by organizations and individuals in the public and private sectors. The development of a similar document for the next decade, Healthy People 2010, provides an opportunity to learn from the experiences of various stakeholders about the use of the Healthy People 2000 document as a standard of comparison and as a framework for results-oriented performance measurement. The creative review of Healthy People 2000 is especially important in light of increased national emphasis on performance and accountability, and various changes in the health care system, such as the growth in managed care arrangements, limits on access-to-care and insurance coverage, and the intersection of public health and personal health care functions. High quality input from the people and organizations who have the commitment and resources to endorse the Nation's health goals, objectives, and priorities, and from those who provide health care services is essential before a new framework for Healthy People 2010 can be developed. Consequently, creative ideas for revision of Healthy People 2000 and thoughtful responses to these ideas were sought from the Healthy People 2000 Steering Committee and Consortium.
Methods
Two major activities were undertaken: (1) a Steering Committee retreat and (2) 7 focus groups, involving a total of 58 participants from various member organizations in the Healthy People 2000 Consortium. Various themes were identified in the process of gathering data, review, and revision. Questions and options were revised based on Steering Committee input and a pilot focus group of Consortium members. The final set of questions for the focus groups dealt with issues involving the extent of a required overhaul of the Healthy People 2000 document; what works and does not work about the functioning of the document; and the implications of changing the document, its priority areas, and the criteria for selecting objectives. Each successive focus group allowed for further review of issues raised in the preceding focus groups. For example, the last focus group included representatives from employers/purchasers and managed care providers in order to address the recurrent theme of the growing importance of business, employers, and managed care.
Findings
Major findings were gleaned from the comments of the Steering Committee and the Consortium focus groups, both collectively and individually. The primary finding was that the Healthy People 2010 document should serve as a voice for public health. Other recommendations were to include the goals of establishing a healthy environment, increasing years of quality life, and making the Healthy People 2010 document relevant to purchasers of health care services. The most prevalent theme in the Steering Committee retreat was the size of the Healthy People 2000 document and the number of objectives and priority areas. Some Steering Committee members thought that the new document should be reduced in size. However, most members felt that local policymakers would want more options to specifically address their circumstances. Others believed that continuity would be ensured if the document were not substantially changed.
Steering Committee members were more willing than Consortium members to make major changes in the organization and content of the document. "Life stages" were considered as an alternative way to conceptually organize the document because it would make Healthy People 2000 more about people and less about health departments. However, many Consortium members believed that most groups who use Healthy People 2000 at State and community levels would find it difficult to change their plans given organizational structure and funding streams. Most Consortium members emphasized other creative changes in the presentation, including taking advantage of the Internet and related technologies and allowing for more flexibility in how the document is organized and accessed. Important themes discussed in all settings were the presentation, comprehensibility, and marketability of the document. Consortium members were concerned about the potential usefulness of the document in communicating with different audiences, including community coalitions, business partners, and the public.
Use of Results
This report provided the opportunity for wide-ranging discussion of Healthy People 2000's impact on the health of the Nation. This discussion helped to identify areas for improvement and modification in the next iteration of national public health goals and objectives, Healthy People 2010. The suggestions for change in content, format, and dissemination of Healthy People 2000 are based on the experience of organizations and people on the front line of public health, health care service delivery, and resource utilization. As such, Healthy People 2010 will benefit from the insight and commitment of those who have not only endorsed national health goals but who have the responsibility to achieve them. The full report is available on the Internet at http://web.health.gov/healthypeople.
AGENCY SPONSOR: Office of Disease Prevention and Health Promotion
FEDERAL CONTACT: Deborah R. Maiese
PHONE NUMBER: (202) 401-5809
PIC ID: 6491
PERFORMER ORGANIZATION: Academy for State and Local Government, Washington, DC
POLICY ANALYSIS AND DEVELOPMENT
Impact of the Medicare Fee Schedule on Teaching Physicians
Highlights
This study assessed the impact of a new Medicare Fee Schedule (MFS) on the revenues of teaching physicians. The new MFS, initiated in January 1992, is based on the Resource-Based Relative Value Scale; it altered the relative prices paid to physicians. Relative payment levels were greatly increased for visits (less intensive relative value units, [RVUs]), and reduced for most types of diagnostic tests and surgical procedures (more intensive RVUs). Relative payment levels were raised in rural areas and lowered in large urban areas. It was hypothesized that teaching physicians would be adversely affected by the MFS because they perform more high-technology procedures and provide comparatively fewer primary care services. In addition, they are located in large urban areas, and often experience customary charges that may be higher than the area-wide historical payments calculated for fee schedule transition. Further, some academic medical practices had not signed Medicare participation agreements and would be affected by MFS limits on balanced billing. The study analyzed all Medicare Part B claims associated with discharges during 1991-1993 from a sample of teaching and non-teaching hospitals. Part B revenues and selected price variables were assessed for different categories of service. No evidence was found to suggest that teaching physicians had been adversely affected by the MFS. A reduction in prices and the quantity of services per admission led to a similar percentage decline for inpatient revenues per admission in all types of hospitals. An increased shift of diagnostic tests to outpatient settings, a secular decline in some surgical procedures, and MFS-related coding changes led to a general decline in inpatient physician service intensity. Teaching physicians altered the mix of services provided, substituting less RVU-intensive visits for high-tech diagnostic tests.
Purpose
The purpose of this study was to evaluate whether and how the MFS had a disproportionate impact on teaching physicians compared to non-teaching physicians. The study also addressed whether physicians in large teaching hospitals, especially academic medical centers, were more affected than physicians in small teaching hospitals.
Background
Methods used by Medicare to reimburse physician services were fundamentally changed in January 1992. A new MFS was initiated, which was based on the Resource-Based Relative Value Scale and which dramatically altered the relative prices paid to physicians. Relative payment levels were greatly increased for visits (less intensive RVUs) and were reduced for most types of diagnostic tests and surgical procedures (more intensive RVUs). In addition, the MFS adjusted payments by a Geographic Practice Cost Index, which took into account the actual costs of physician practice in different parts of the country. This adjustment raised relative physician payment levels in rural areas and lowered them in large urban areas.
It was expected that the redistributive effects of the MFS would be particularly adverse for teaching physicians, who perform relatively more high-technology procedures and less primary care and who are located in large urban areas. Customary charges for teaching physicians also could be higher than the area-wide historical payments calculated for fee schedule transition. In addition, an unknown number of academic medical practices had not signed Medicare participation agreements, and the MFS limits on balance billing could further constrain revenues for some teaching physicians. Prior research had shown that physician responses to Medicare fee reductions will depend on the relative magnitude of income effects, such as an increase in service volume to offset a fall in revenue; and substitution effects, such as an increase in services to non-Medicare patients. Relatively little is known about physician response to Medicare fee increases. It was hoped that higher visit reimbursement levels under the MFS would lead physicians to encourage more contact with patients.
Methods
A stratified random sample of 701 hospitals was selected from Medicare's 1991 Provider of Service file. The strata were defined by teaching status of the hospital, ranging from academic medical centers to non-teaching hospitals. MedPAR records for all discharges from the sample hospitals during 1991-1993 were identified. Using the Health Insurance Claim number of these records, all Part B claims associated with these discharges were extracted.
Key revenue and price variables were constructed for each hospital-year: Part B revenues per admission, RVUs per admission, a price per service index, and a price per RVU. Each of these variables was created for overall inpatient services, and for five separate categories of service: evaluation and management services; high-tech surgical procedures (RVUs of 40 or more); general (all other) surgical procedures; high-tech tests (RVUs of 1.3 or more); and routine (all other) tests.
Findings
There was no evidence that teaching physicians were adversely affected by the MFS. Inpatient revenues per admission fell by the same percentage in all types of hospitals. Revenues fell because of a reduction in prices and the quantity of services per admission. The contributions of price per RVU and RVUs per admission to the declines in revenue were similar across all hospitals. A general decrease of inpatient physician service intensity resulted from a shift of diagnostic tests to outpatient settings, a secular decline in some surgical procedures, and MFS-related coding changes. Teaching physicians appear to have altered the mix of services provided (and/or billed for) by substituting less RVU-intensive visits for high-tech diagnostic tests. As a result, the actual decline in price per RVU was similar for teaching and non-teaching physicians.
Use of Results
The study documents the successful impact of Medicare's new RVU-based physician payment system on overall revenues and the substitution of less costly, more visit-oriented services for high-tech diagnostic services. The methods used will help to assess substitution and income effects associated with physician responses to future Medicare price changes and should result in more accurate estimates of Medicare program savings. The results suggest that price decreases will be associated with increasing volume but decreasing intensity per service and, thus, are important for monitoring future volume changes and determining the appropriate level of sustainable growth in physician services.
AGENCY SPONSOR: Health Care Financing Administration, Office of Strategic Planning
FEDERAL CONTACT: William Buczko
PHONE NUMBER: (410) 786-6593
PIC ID: 6666
PERFORMER ORGANIZATION: Center for Health Economics Research, Waltham, MA
Informal and Formal Kinship Care
Highlights
This study used existing national data sources to describe the characteristics of children in kinship living arrangements and to define recent trends in the pattern of kinship caregiving. Comparisons were made between formal kinship arrangements, in which foster care were provided under State auspices, and informal kinship arrangements, in which care was provided by relatives in the absence of a parent--but without State intervention. Over 2 million, or 3 percent, of all children in the United State are in kinship care (defined for study purposes as a child living in a relative's household without a parent present). Kinship caregiving and the children living in single-mother families both appear to be adaptations to family disruption and the decline of the traditional two-parent family. The majority of children in kinship care are white. However, African-American children are four to five times more likely to live in kinship care settings than white non-Hispanic children. Kinship care providers tend to be older than parental caregivers (about two-thirds of care providers are grandparents), and more likely to be poorly educated, out of the labor force, below or near the poverty level, and recipients of public assistance programs. Persons caring for their related children tend to be an economically and socially marginal class. Formal kinship care tends to be a creation of local policy, agency practice, and public administration. Children in formal kinship care tend to be under 5 years of age, African American, and highly urban. They are likely to draw more public attention than the generally white, older, and non-metropolitan children in informal kinship care. Several data issues are addressed in the report, as is the potential influence of changes in the welfare system on the future role of kinship care.
Purpose
This study used existing national data sources to describe the characteristics of children in kinship living arrangements in the United States, to identify recent trends in the pattern of kinship caregiving, and to compare formal and informal kinship care arrangements.
Background
The foster care population has grown by over 60 percent during the past decade. This increase has been attributed to increased reporting of abuse and neglect, the spread of crack-cocaine addiction, increased levels of poverty, reduced caseworker staffing, increased duration of stay, and court-ordered reform. Kinship foster care has also grown during this period, rising to 54 percent of all foster care in Illinois, 45 percent in California, and 36 percent in New York in 1993. In 1994, 3.1 percent of all children were estimated to be in kinship care. Children in informal kinship settings (provided by relatives in the absence of a parent, but not as foster care under auspices of the State) are of particular importance for the child welfare system as an alternative model of caregiving and as a potential "feeder" population for more formal arrangements provided by the State. Recent welfare changes may further accelerate the growth in kinship care arrangements. More information is required, however, about trends in the demographic and socioeconomic characteristics of national and State patterns of formal and informal kinship care.
Methods
Data on national patterns and trends in kinship care are drawn from 12 years of the Current Population Survey (CPS). State data on living arrangement patterns come from the 1990 Census of Population. Administrative foster care records in California, Illinois, New York, and Missouri provide a breakdown of children living with relatives into separate categories of formal and informal kinship care. These data allow for aggregate State analysis and for analysis of "primary urban places" (such as Chicago and Los Angeles County) in comparison to the rest of the State. In the State of Illinois, individual-level records were examined for all recent (1990-1995) child AFDC grant recipients and all foster children in the State. These data were accessed from the Illinois Child Multi-Service Data Base and allowed analysis of transition in foster care arrangements. Study variables included race/ethnicity, age, gender, poverty status, employment status, marital status, geographic area, family structure, characteristics of caregiver, and type of kinship care.
Findings
National trend analysis indicates that children in kinship care are disproportionately made up of minority children and cared for by relatives who are much older, less educated, poorer, and generally with fewer advantages than parents who live with their own children. Living arrangement patterns by State indicate that kinship care levels across States tend to vary strongly and inversely with the proportion of children living within a traditional two-parent family structure--kinship care appears to be a direct product of higher levels of social disruption and family disorganization. Analysis of administrative foster care records shows that African-American children are about eight times as likely as all others to be in formal kinship placements. This racial effect holds across regions and age groups. Informal kinship care is much more common than formal kinship care, which tends to be concentrated in urban places. In the four States studied, 15.5 percent of all children in kinship living arrangements were in kinship foster care (the range among States was 2.7 to 22.5 percent). The remainder were in informal arrangements.
Analysis of AFDC grant recipients and all foster children in the State of Illinois indicates that formal kinship group is younger, disproportionately African American, and living in Chicago. Most children remain in their current status over time. AFDC children living with relatives are about twice as likely to move into formal kinship care as are AFDC children living with their parents, although the likelihood of such a change is less than 2 percent per year. Children who move between different AFDC and kinship settings tend to be younger.
Several data issues were discussed, including the importance of individual-level data in order to control for race/ethnicity and poverty status; the difficulty of clearly defining family relationships, such as the presence or absence of a child's parent, in survey data; and the need for large population surveys in order to obtain a sufficient number of kinship care cases. Recommendations included the maintenance of baseline information on kinship care, more detailed information on the living arrangements of children, conducting similar data analysis for additional States, and creating linked and integrated information resources describing the full range of children's contacts with social services and other public systems.
Use of Results
The descriptive analysis of kinship care arrangements can inform national and State policy on welfare reform and family support. These analyses informed debate on sections of the Adoption and Safe Families Act (Public Law 105-89), which includes provisions on kinship care. They also will be used to prepare a report to the Congress on kinship care and in the work of a Federal Advisory Committee on Kinship Care ordered by that law. This study and related work also will be used to better understand caseload shifts in safety-net programs following welfare reform and their effects on children and families. Variations in the size and prevalence of the kinship care population are related to stresses in the social conditions of families. The number of children in kinship care might serve as a barometer of the impact of social and economic problems on family structure. Welfare changes are likely to affect the transition of children between various living arrangements, both formal and informal. Information is needed to track the family status of children at risk and the types, timing, and reason for changes in kinship care arrangements.
AGENCY SPONSOR: Office for the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy
FEDERAL CONTACT: Laura Feig
PHONE NUMBER: (202) 690-5938
PIC ID: 6016
PERFORMER ORGANIZATION: University of Chicago, Chicago, IL; and Urban Institute, Washington, DC
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report
Highlights
This study analyzed the market barriers to the development of drug therapies for substance abuse and addiction, and for cocaine use and addiction in particular. Using market analysis, quantitative modeling, case studies, and industry interviews the study concluded that the development of a new cocaine pharmacotherapy was not economically viable for the pharmaceutical industry under current market conditions. Three critical market barriers faced by the industry included the small and uncertain market for cocaine addiction and abuse drug therapy, a substance abuse treatment system that limits access to this market, and limited and uncertain payment. Public strategies to lower these barriers include government funding of a considerable portion of new drug development; expansion and enhancement of the substance abuse treatment systems; creation of a guaranteed market, such as through purchase orders for minimum volumes of a medication; and extended market exclusivity, which would tend to give the therapies an "orphan drug" status.
Purpose
The purpose of this project was to analyze market barriers to the development of medications for substance abuse and addiction, with emphasis on cocaine abuse and addiction. Information was to be provided on the characteristics of the market for substance abuse pharmacotherapies, real and perceived market barriers, case studies of pharmaceutical companies that have developed and marketed substance abuse medications such as LAAM (levo-alpha-acetylmethadol hydrochloride) and naltrexone, and the industry's perception of the readiness of the science base for the development of substance abuse pharmacotherapies.
Background
Pharmacotherapy offers a means for improving the treatment of drug addiction. However, only a handful of medications have been developed and approved by FDA for treatment of opiate addiction during the past 30 years. A 1995 report by the Institute of Medicine on the development of anti-opiate and anti-cocaine medications found a reluctance on the part of the pharmaceutical industry to enter the field of anti-addiction products because of considerable market disincentives. These included an inadequate science base on addiction and the prevention of relapse, uncertain treatment financing, lack of specialists for treatment of drug addiction, Federal and State regulations, market size, pricing issues, societal stigma, liability issues, and difficulties in conducting clinical research.
Methods
A market analysis was performed for a prospective cocaine medication from the perspective of a pharmaceutical company. Data were compiled on the prevalence/incidence of opiate and cocaine addiction, current rates of treatment, and existing patterns of service delivery/financing for drug treatment. A market analysis model was designed to determine the expected profitability of a particular product. This analysis incorporated development cost, product sales, manufacturing/distribution costs, and the product/sales life. Financial indicators such as product net present value and peak annual revenue of the product were computed. Quantitative modeling was done based on hypothetical scenarios of company decision-making.
Case studies were conducted for the selected pharmacotherapies of LAAM, naltrexone, clozapine, and Nicorette. Literature reviews involved direct search of computerized data bases on clinical trials, product development, and marketing. Five private firms were interviewed to explore and characterize their views on market barriers and the readiness of the science base in developing medications for substance abuse and addiction. A detailed discussion guide served as an interview protocol.
Findings
Market analysis indicated that a combination of factors minimizes the attractiveness of the cocaine abuse market to the pharmaceutical industry. These include a relatively modest potential market (2.1 million heavy users), a low proportion of users currently in treatment (250,000 enrollees on any given day), concerns about compliance in this population, and apparent market expectation of a low price point. Anticipated low market penetration is reinforced by a substance abuse treatment model that generally emphasizes psychosocial rather than medical intervention. The treatment system involves little or no physician time in the treatment of patients. High price sensitivity of treatment programs subject to annual government appropriations has contributed to the disappointing market experience of two substance abuse medications, LAAM and naltrexone. Because the average treatment cost is $9.00 per day for non-intensive patients, which would be consistent with the great majority of all cocaine abuse patients, a cocaine medication price at a daily dose of a few dollars would represent a significant proportionate cost increase.
Quantitative analysis of various scenarios of corporate decisionmaking and market conditions indicated that the prospects for developing a new medication for cocaine abuse and taking it through a full product development cycle do not appear favorable given a moderate wholesale price and the expected market penetration. Financial returns are not sufficient to justify the participation of larger pharmaceutical companies. Case studies of selected medications documented the significant market barriers to pharmacotherapies for substance abuse and addiction, and the important role played by favorable government interventions--FDA fast-track approval (LAAM, clozapine, and Nicorette), modified phase IV clinical trial requirements (ReVia), market exclusivity (orphan drug status or other market protection for all four drugs), and mandated Medicaid coverage (clozapine).
Three market barriers would have to be reduced or eliminated in order to make new drug development attractive to pharmaceutical companies. One barrier is the small and uncertain market for cocaine addiction and abuse medication, given patient compliance problems, limited access to patients, and non-physician treatment managers who oppose the use of drugs to treat substance abuse. A second barrier is that the substance abuse treatment system limits access to the market, partly through the "anti-medication" climate among publicly-funded treatment staff. The third barrier is limited and uncertain payment for pharmacotherapy, given that substance abuse services continue to be subsumed under mental health benefits of shrinking entitlement programs, and given that high price sensitivity/resistance may limit market size. Pharmaceutical company interviews also indicated disagreement about the readiness of the science base for cocaine pharmacotherapies.
Possible government actions to overcome market barriers and to improve opportunities for developing cocaine addiction medications would include funding of a considerable portion of new drug development, expansion and enhancement of the substance abuse treatment system, guaranteed markets or purchase orders for minimum volumes of a medication, and extended market exclusivity via orphan drug status.
Uses of Results
The study complements the findings of the Institute of Medicine's earlier report. It tests various market assumptions to confirm the lack of economic viability for the development of substance abuse treatment medications and the importance of government intervention to lower critical market barriers if development and availability of such medication is deemed a desirable public policy goal. The results provide public decisionmakers with valuable information to weigh the potential advantages and disad-vantages of alternative policy actions in this area.
AGENCY SPONSOR: Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy
FEDERAL CONTACT: Kevin Hennessy
PHONE NUMBER: (202) 690-7272
PIC ID: 6694
PERFORMER ORGANIZATION: The Lewin Group, Fairfax, VA