OVERVIEW Center for Education and Research on Mental Health Therapeutics Rutgers University Presented at CERTs Steering Committee Meeting Washington, D.C. April 20, 2006 Aims and Core Strategies • Bring together research teams to implement an interrelated set of studies addressing selected issues with major public health significance in mental health therapeutics, emphasizing populations receiving care through major public programs such as Medicare and Medicaid (key payers in mental health), with a focus on youth and the elderly, aimed at: – Building the research base for evidence-based practice through better information on psychotropic use, safety and outcomes – Addressing the efficacy-effectiveness gap by assessing psychotropic medication use in “real-world” settings and identifying targets for intervention. – Providing a foundation for educational initiatives, interventions, and system/policy level efforts to improve care and outcomes. Aims and Core Strategies • Develop and implement educational activities and interventions that translate research into practice, improving the quality and outcomes of psychotropic drug use in a range of settings, and targeting diverse points of intervention such as specialty and primary care clinicians; institutional providers (e.g., nursing homes); patients and families; and system-level actors (e.g., governmental and private payers, state agencies, regulators, health plans, policymakers). Aims and Core Strategies • Develop and maintain a core data resource infrastructure for mental health therapeutics that more fully realizes the potential of administrative healthcare data for pharmacoepidemiological, safety, and outcomes research, by: – Creating and managing extensive multistate public-payer research datasets supporting multiple related studies, – Developing capabilities to track treatment and outcomes for Medicaid and Medicare beneficiaries as payment systems and policies change, – Assuring rigorous protection of patient confidentiality, – Developing synergy across projects, – Creating and utilizing data linkages that address some of the typical limitations of administrative data, and integrate key clinical, provider and contextual information, – Creating data resources that can support analysis of services use across multiple payment systems (e.g., Medicare/Medicaid dual eligibles). Aims and Core Strategies • Provide methodological support in effective utilization of econometric and statistical methods to address threats to validity in observational research on outcomes. • Develop core education/translation/intervention infrastructure that supports translation of research findings into practice. • Develop partnerships to support intervention at system and policy levels, including state agencies, health plans, and professional organizations in the mental health field. • Develop data resources and strategies for examining quality and appropriateness of psychotropic use, addressing policy development issues, Rx use and outcomes for mental health conditions in the Medicare Part D program, including dual-eligibles. Aims and Core Strategies • Become a national resource on mental health therapeutics that is trusted for its expertise, its integrity and independence, and its rigorous, objective and creative work, addressing “realworld” treatment and outcomes for large, diverse populations in usual-care settings, and treatment challenges of major public health significance. Preliminary Studies: What We Build On • The mental health CERTs represents the next step in a • multi-year developmental process based at Rutgers and reflecting consistent underlying vision. AHRQ-funded Building Research Infrastructure (BRIC) center, 2001-2006--aimed to begin development of large dataset resources to support multiple HSR studies; develop partnerships; support developmental and pilot work for grant applications; jump-start HSR in NJ; examine disparities. Outcomes include AHRQ and NIH R-01s, training awards, publications, etc. as well as datasets and strategies on which CERTs builds. Preliminary Studies: What We Build On • Line of Medicaid based research since late 1980s with • major focus on Rx drug use—initially focusing on HIV/AIDS treatment, modeling initiation, continuation and consistency of antiretroviral use as well as comorbid conditions such as SMI, supported by R01s from AHRQ, NIDA and NIMH as well as NJ Dept. of Health and other sources. Persistence studies. Studies on pharmacotherapy in mental health, supported by NIMH mental health services research center at Rutgers and by NIMH R01s including studies on geriatric depression treatment in the community, depression in nursing homes, and HIV and severe mental illness. Strong hx of MHSR at RU. Preliminary Studies: What We Build On • Work on LTC quality with NJ Dept. of Health and • • • Senior Services, including consumer satisfaction measurement and current CQI intervention. LTC research using MDS, OSCAR and other databases. Hx of collaborative work with state agencies in NJ and other states, including state mental health agencies, Medicaid, LTC, through Rutgers Division on Aging and Center for State Health Policy (RWJF-funded). Projects on pharm policy and elderly (Commonwealth Fund, KFF, AARP); focus on state interface; past and current work on Part D policy including data access issues. SPAPs, conferences for state policymakers. Coverage, OOP burden/impact; health plan collab. Preliminary Studies: What We Build On • Academic collaborations—including those between • • • psychiatric researchers at Columbia and other sites and mental health services researchers at RU. Rutgers Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes – funded through RU Academic Excellence Center Award, 2004. Focus on societal challenge of sub-optimal use of the Rx armamentarium as a crucial public health issue. Provided support for CERTs planning process. Planning Process • Systematic, consultative process to identify and prioritize the most important psychopharm tx and outcomes issues for a mental health CERTs to address: – high population health impact; – mismatch between evidence-based recommendations and widespread practices; – emerging safety concerns; – disparities and high variability in practices without apparent clinical rationale; – critical weaknesses in the knowledge base; – potential for significant impact in improving practices and outcomes. Planning Process – Process included weekly meetings and conference calls among internal and external collaborators, circulation and discussion of literature syntheses, outreach to a wide range of experts and organizations. – Identified key problem/themes and candidate projects within themes. – Project selection considered public health importance, achievability, potential to leverage CERTs resources into outcome improvement and independently sustainable studies and interventions. – Strategy development will be ongoing process. – As I’m sure each center found, fitting the vision into the budget was very challenging. Challenges of Education/Translation/Intervention in Mental Health Therapeutics – Achieving sustained change is difficult. – CERTs resources limited; leverage essential. – Often unclear where/how best to intervene – treatment patterns in diverse settings and subpopulations often not well identified. Need to develop metrics + capability to track them. – “Retail” educational efforts such as traditional CME and other prescriber education often ineffectual in face of inertia, information overload, heavy marketing, etc. Many possible models examined. – Multiple levels of influence on use and outcomes (patient/family, clinician, system) can act at cross-purposes and limit effectiveness of single-level interventions. – Given limited resources, special need to address system level of influence. Organizational and Policy Guidelines Quality Measurement Provider Profiling, Feedback, Incentives Disease Management Use of Information Systems (e.g., reminders, prompts) Formularies Dispensing policies, prior auth/step therapy, PRODUR, etc Benefit design and coverage, cost-sharing Clinician Training and background Knowledge of current evidence Patient interaction skills Values, norms, self-efficacy Peer influences Behavioral intentions and cues (see Figure 2 for elaboration) Patient/Family Enabling Need Provider interaction skills Predisposing (including information/ education, direct-toconsumer marketing, values/beliefs, self-efficacy, behavioral intentions and cues) Quality of Initial Diagnosing and Prescribing Management of Regimens, Doctor-Patient Communication Adherence Right Patient Gets the Right Treatment at the Right Time (Treatment Initiation, Dose, Duration, Monitoring and Management) Outcomes: Clinical, Hospital and Other Service Use, Expenditures Conceptual Framework Subcontractual/Consortium Partners • • Columbia University/New York State Psychiatric Institute. – Among world’s leading psychiatric research centers. – Close relationship with NY State Office of Mental Health. – Columbia based collaborators include Mark Olfson, MD, MPH (Co-PI) and Peter Jensen, MD (Co-Chair, Child and Adolescent Core). Builds on long-standing collaborations. American Psychiatric Association/American Psychiatric Institute for Research and Education (APIRE) – Key mental health stakeholder and link to clinical provider community – Important role in clinician and public education. – APIRE based collaborators include Darrel Regier, MD, MPH, and Joyce West, Ph.D., MPP. Cores • Substantive Cores – Child and Adolescent – Adult, Elderly and Comorbidity • Support Cores – Administrative and Policy – Data Resources, Analysis and Methods – Education, Translation and Intervention Core Data Resources • • • • • Medicaid claim and eligibility data from Medicaid Analytic Extracts (MAX) for eight states. – Merged with Medicare data for dual-eligibles. – Merged with contextual and provider data (e.g., Area Resource File). Medicare Current Beneficiary Survey. Nursing home MDS merged with Medicaid claims. Other data resources include health plan data, NAMCS/NHAMCS, Medicaid claims data from individual states, MEPS, HRS Rx mail survey, etc., on project by project basis. Medicare Part D data, merged with Part A and B—as they become available to researchers. A priority will be to work with AHRQ, CMS, FDA and the CERTs consortium toward construction and use of Part D research datasets for research on use, outcomes and policies related to mental health pharmacotherapy in Medicare, especially for dual eligibles. Selected Projects • Toward Safer, More Effective Use of Antidepressant and Antipsychotic Medications Among Children and Youth – Use and Monitoring of Psychotropic Therapy Among Youths • Includes substudies on antipsychotics, antidepressants. • These analyses will utilize Medicaid data to examine patterns, predictors, and trends in use of psychotropic medications among Medicaid children and adolescents, and the extent and predictors of appropriate patterns of professional monitoring based on medical encounters in the claims record. Sub-studies address use and monitoring of antidepressant therapy among youths, and quality of antipsychotic treatment, widely used among Medicaid youth without psychosis diagnosis, often for problems related to aggressive behavior. – SSRI Use and Suicidality in Depressed Youth • This study will utilize national data on young Medicaid beneficiaries with depression to examine associations between antidepressant exposure and rates of suicide and suicide attempts. – Evaluation of Web-Based Parents’ Guide for Treatment of Child and Adolescent Depression. • This study will evaluate the impact of the web-based parents’ guide developed by the American Psychiatric Association and the American Association of Child and Adolescent Psychiatry and used by hundreds of thousands of families. – Guideline Development and Prescriber Training to Improve Prescriber Practices for Antidepressants and Atypical Antipsychotics in Children: The Texas-New York Medication Algorithm Project (TNY-MAP) • This two-state initiative to improve prescriber practices, in cooperation with state offices of mental health in two large states, will adapt the Treatment Recommendations for Atypicals in Aggressive Youth (TRAAY), originally intended for inpatient settings, to outpatient settings; integrate and develop cross-walks between Texas- and New York-developed SSRI guidelines; train samples of outpatient prescribers in the two states to apply modified TRAAY and SSRI guidelines; evaluate program impact; and develop and deploy web-based educational programs to assist prescribers to implement best practices in the use of atypicals and SSRIs. Quality and Outcomes of Pharmaceutical Care for Beneficiaries with Mental Illness Under Medicare Part D • Impact of MMA Formularies on Beneficiaries with Mental Illness – Analysis of MCBS data to model impact of alternative formulary choices. • Quality and Outcomes of Therapeutics for Medicaid-Medicare Dual Eligibles With Mental Illnesses in the MMA Era: Development and Use of a Research Dataset – This will be a continuing core activity over next five years; timing of efforts will depend on developments in data access—a topic of mutual concern with AHRQ and across CERTs. Claims-based studies in Medicare populations provide strong foundation for evolution into work with more recent Part D data. – Outcomes for dual-eligibles are of particular concern as rules have changed for this population, who shifted from state Medicaid programs (typically open-formulary) to private plans on 1/1/06. A substantial portion of the approximately 6.5 million dual-eligibles have psychiatric conditions, including many SSI beneficiaries who are disabled due to mental illness. Improving Psychotropic Medication Use Among Adults and Elderly • Guideline-Consistent Management of Antidepressant Treatment for Adult Depression – Examine variations in quality of treatment management among Medicaid beneficiaries in multiple states, including duration and monitoring of therapy. • Atypical Antipsychotic Drugs in Nursing Homes: Implementing Treatment Recommendations for Frail Elders – Examine current patterns of treatment including diagnoses, behavior/symptoms, duration, intensity, polytherapy, etc. – Identify decisionmaking processes, roles of multiple actors; examine quality measurement processes. – Consult with experts and regulators on strategies. – Initiate planning to develop and pilot test an intervention. Atypical Antipsychotic Drugs in Nursing Homes: Implementing Treatment Recommendations for Frail Elders (cont) – Use of older “typicals” (Haldol generation of drugs) was high-profile issue in late 1980s. Rates came down in wake of 1987 reforms, but have been increasing in era of atypicals perceived as much safer, along with general increase in off-label use of these drugs for behavioral and psychological symptoms of dementia, such as agitation. – Work by Ray and others in late 1980s-early 1990s showed that carefullydesigned interventions involving multiple members of care team could lead to more-selective and lower overall use rates. However, sustained change may be difficult. In NH setting, challenge probably involves more than just providing information to prescribers. Multiple actors are involved. Facilities understaffed; providers need to work as team on alternative ways to manage problematic behavior. Regulation, monitoring, quality measurement all play a role. – More generally, use of atypicals in the frail elderly has become an important challenge. According to clinical lore, effectiveness is high, but available trial data suggest effectiveness is modest though detectable. Impact on QOL is unclear. Available studies provide inadequate guidance on selection of patients/agents and other aspects of therapy. Improving Psychotropic Medication Use Among Adults and Elderly • Atypical Antipsychotic Drugs in Nursing Homes: Implementing Treatment Recommendations for Frail Elders (cont) -- Issues – Several recent developments have created further uncertainty for clinicians about indications and outcomes: • One meta-analysis of RCTs (Schneider, JAMA 2005) estimated excess overall mortality of about 1% over 6-12 weeks of followup. • Based on a similar meta-analysis that included additional, unpublished studies available to them, FDA imposed black box warning. • Concerned that switches to older typicals could make matters worse, Wang et al (2005) compared survival in users of typicals vs. users of atypicals, concluding that the former were at higher risk. Concluding Comments • • • Mental health poses some of the most challenging problems for therapeutics. Intervention to produce sustained improvement is not easy and will require careful and thoughtful planning and targeting of efforts, and continuing collaboration with a range of stakeholders. Need for a CERTs to focus specifically on mental health is high. Many populationspecific issues; need to work with both mental health specialty and primary-care sectors, as well as public agencies whose role is especially important in mental health. Medicaid and Medicare including Part D are key in this area. This is an excellent area for collaboration given areas of common interest, such as those defined by age groups; program populations (e.g., Medicaid) and important role of medical comorbidity. We are excited about the opportunity to join the distinguished investigators associated with the CERTs network and look forward to working with AHRQ, FDA, CMS, our CERTs colleagues, and others concerned with these issues.