Implementation of Delivery Service System Innovations in Mental Health: Challenges and Outcomes

1. Implementation of Delivery Service System Innovations in Mental Health:Challenges and Outcomes Stephen Crystal, Ph.D. Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes/ Center for Education and Research on Mental Health Therapeutics/RU DEcIDE Rutgers University Presented at AHRQ Annual Meeting Bethesda September 19, 2011

2. Overview • This presentation will discuss several activities our center is undertaking on behalf of AHRQ and mental health stakeholders, supported through COE’s DEcIDE and CERTs programs and by CDOM (MEDNET). • Questions: • For publicly funded mental health care, what strategies show promise for increasing the uptake of evidence based practices? • What are the challenges that confront patient-centered outcomes research on service delivery system interventions for serious mental illness?

3. Background • Mental health conditions account for a substantial share of overall illness burden and health care expenditure, both directly and through their impact on the course and treatment of co-occurring medical conditions. • However, our health care systems often perform poorly in attaining appropriate care processes and outcomes in this population. Uptake of evidence based practices is uneven; fragmentation of care between mental health and general medical care systems a key problem. •  State Medicaid and mental health programs play central role; Medicaid will assume even larger role in this area in the wake of coverage expansions under the Affordable Care Act.

4. Example: Challenges of Increased/Broadened Antipsychotic Use Continued increase in rates of atypical antipsychotic (AAP) medication use for a broadened range of patients and indications, often off-label, has raised a range of policy challenges for payers, patients and clinicians (Crystal et al, Health Affairs, 2009). Particular concerns about increased use among youth, given metabolic and other risks as well as uncertainties about long-term developmental effects. Antipsychotics most costly medication class for Medicaid. Quality concerns include polypharmacy, adherence, dosage, adequacy of assessment and monitoring, use for foster care youth, and others.

5. Annual Antipsychotic Use Rates by Foster Care Medicaid FFS Youth* Ages 6-172001 - 2005__________________________________________________________ • MAX all states except AZ, DE, DC, OR, NV, RI, NJ, ME

6. Hierarchical Diagnostic Groups Among AP Users Medicaid FFS Youth Ages 6-17*________________________________________________________________ * MAX all states except AZ, DE, DC, OR, NV, RI, NJ, ME

7. Other Psychotropic Medication Use in AP Users Medicaid FFS Youth* Ages 6-172001 - 2005_______________________________________________________________ * MAX all states except AZ, DE, DC, OR, NV, RI, NJ, ME

8. Trends in Use Among Children and Youth In recent years antipsychotic use rates among youth increased substantially, with a substantial portion of use received by youth who did not receive a diagnosis of schizophrenia, autism, bipolar, CD or DBD. Much of this use is likely a response to aggressive symptomatology. It is likely that many youth treated with APs for aggressive symptoms never received an adequate, comprehensive mental health assessment, a trial of psychotherapeutic intervention prior to AP treatment, or psychotherapy provided concurrent with AP treatment. Adequacy of monitoring is uncertain.

9. MMDLN/Mental Health CERTs 16-State Antipsychotics in Children Study • This area was prioritized by MMDLN for collaborative work with CERTs as a result of joint MMDLN/mental health CERTs conference in 2007, leading to 16-state project on antipsychotics in children (see report and resource guide at rci.rutgers.edu/~cseap, or googlemmdln/rutgers antipsychotic guide). • Actions taken by states in response to project documented in report’s Epilogue and in MMDLN quarterly newsletters.

10. ACP Report/Resource Guide and other materials including Epilogue on impact of project at: http://chsr.rutgers.edu/MMDLNAPKIDS.html (or google Rutgers MMDLN Resource Guide) MMDLN update on state actions and study impact: http://chsr.rutgers.edu/MMDLNAPKIDS/mmdlnnews1.pdf Clinician’s Toolkit for Management of Atypical Aggression in Youth http://www.chainonline.org/content.cfm?menu_id=232 Email: scrystal@rci.rutgers.edu

11. Lessons Learned from ACP Project • ACP demonstrated potential of researcher/state collaboration in multistate QI initiatives in Medicaid mental health. It highlighted need for follow-on project to support implementation of evidence based practices, engagement of providers and other stakeholders, necessary data/metrics infrastructure, and initiatives to address treatment challenges in adults. • Project identified: • vital role of stakeholder engagement and systematic collaboration; • need for development and implementation of appropriate quality metrics for decision support, provider feedback and quality improvement. • promising practices that warrant dissemination across states, including provider feedback with followup, clinic based QI collaboratives, second opinion strategies.

12. MEDNET • Building on experience of the ACP, a group of states worked together with Rutgers and other partners to develop a plan for a systematic, collaborative, multistate initiative to accelerate the implementation of comparative effectiveness findings in Medicaid funded mental health care, addressing treatment challenges for adults as well as children and utilizing common quality metrics to support problem identification, monitoring, and provider feedback interventions.

13. MEDNET Mission • Accelerate adoption in Medicaid mental health of two types of CE findings: • Findings on effectiveness and safety of specific clinical practices, in particular patient populations; • Findings on effectiveness of organizational practices, strategies and policies related to management of these treatments and of risks associated with treatments across subpopulations.

14. MEDNET Consortium • Multi-partner collaboration focused on increasing utilization of evidence-based clinical and service delivery system practices in provision of mental health treatment for Medicaid beneficiaries. • Partners include California, Washington, Texas, Missouri, Oklahoma, and Maine, in addition to Rutgers, Columbia University, and AcademyHealth. • Participating states account for about 30% of FFS Medicaid enrollment nationally. • Analyses of MAX data from five of these states for 2005 indicate that more than 550,000 beneficiaries received antipsychotic medication prescribed by more than 74,000 prescribers at a cost of $1.4 billion (most costly med class for MA).

15. Initially Targeted Clinical Practices • Psychotropic polypharmacy, including concurrent use of multiple antipsychotic medications. • Safe dosing. • Managing metabolic risks of antipsychotics. • Improving treatment adherence for adults with SMI. • Use of appropriate mental health services and psychosocial interventions as complement or alternative to antipsychotic medication. • Antipsychotic use in children under age 6/foster care. • Assessing and addressing geographical, provider, racial/ethnic, and other variations in treatment practices that lack apparent clinical or epidemiological rationale and may add costs and risks without concomitant benefit. • Consistency of treatments and diagnoses.

16. Prioritization in Year 1 Planning • Clinical practices prioritized included polypharmacy, management of metabolic risks of APs, dosage, adherence; second tier measures include diagnosis consistent with treatment and appropriate use of psychosocial services. • DUA processes underway for release of claims and eligibility data for its Medicaid population; Secure Remote Access system established. • Metrics team developing core set of metrics for tracking treatment patterns, monitoring change over time, and for use in provider feedback and other QI programs. • State-level quality collaboratives and QI plans. • Implementation of state plans in Year 2. • Core set of metrics developed; states developed intervention plans; site visits underway; first annual consortium meeting completed.

17. Examples of State Intervention Approaches • Washington MEDNET: Clinic based QI collaborative, implemented in partnership with Washington Community Mental Health Council (association of CMHCs), translating methods and tools from well developed clinic based QI program in New York State. • State legislature appropriated $300k to extend WA MEDNET model and support development of provider training modules that complement NY materials; will be available to other states. • WA AG office also provided funds from Neurontin settlement. • Complementary focus on 50 high volume outlier prescribers.

18. Washington MEDNET • Kickoff meeting in Seattle with CMHCs (>200 participating). • Expanding provider feedback, benchmarking. Examining, sharing, addressing geographic variation. • Clinical issues targeted: polypharmacy, adherence, dose, rehospitalization, high utilizers. • Integration of data streams; web based data portal (PRISM) provides data for clinics and providers. Potential for access to PRISM strong motivator for clinics.

19. Other States--Selected Highlights • MO—Expanded provider feedback, extension to CMHCs and health homes; stakeholder collaborative; improving metabolic outcomes with required metabolic screening integrated with claims data into electronic health record and portal (CyberAccess). • CA—Managed care based project (Orange County CAL-OPTIMA); focus on cardiometabolic, polypharmacy; identifying “high opportunity” providers; health information sharing. • OK—Very young children; AP without mental health treatment; data integration including Part D (sharing experience with duals planning grant); prescriber feedback; portal development; detailing. • ME—adherence reporting and interventions; cardiometabolic; focus on data stream integration; framework for provider feedback; geographical variation; managing comorbidity. • TX—extending QI initiatives developed in foster care to other populations; portal (MEHIS); identify and intervene w/outlier prescribers.

20. Year 1 Consortium Meeting—Selected Highlights • States requested sessions on Using Data to Drive Quality Improvement; Identifying and Addressing Within-State Variation; Tracking and Sharing Progress; Engaging Providers. • WA shared analyses of within-state variation and their application as a tool for engaging stakeholder community. Illustrative mapping shared with states. • Integrating and more effectively distributing data streams emerged as priority topic; states shared initiatives for data integration, portals. States requested creation of Part D working group.

21. Year 1 Consortium Meeting—Selected Highlights • Tracking and sharing progress: MO and NY shared tools for turning data into information, creating feedback loops, tracking progress (including economic outcomes); initial impacts from 16 state study. • Engaging providers: quality collaboratives increase engagement, reduce pushback, turn payer problems into shared problems; motivators include improved access to data, preferred status for PAs. Peer influences can be powerful. • Widespread interest in development of common guidelines.

22. DATA SOURCES Medicaid Eligibility Files Medicaid MC Encounter Data Medicaid FFS Claims Medicare (A, B, D) State Children Services Data State Mental Health Agency Data Mental Health Carveouts (Managed Care, county, etc) DATA INTEGRATION DATA USERS State Mental Health Agencies State Children’s Services State Medicaid Agency Mental Health Clinics Other Providers/Prescribers Consumers

23. Rates of APM Receipt in Medicaid Youth: MO MAX FFS enrollees age 6-17, 2005 data

24. Discussion • What strategies show promise for increasing the uptake of evidence based practices? • Stakeholder driven not simply researcher driven. • Responsive to unique set of resources, opportunities, structural and financing arrangements, data issues, interagency issues, perceived priorities, previous initiatives on which to build. • Not feasible to impose one single model; one size does not fit all. However, states have a strong desire to learn from one another and to adopt models that have been field tested elsewhere and bugs ironed out. Also strong interest in shared quality measures and, insofar as possible, sharing of intervention models and TA.

25. Discussion • Intervention strategies must deal with very limited administrative resources in many states for implementing QI initiatives. • Critical to identify and work with forward-looking state champions (these projects are not without risk for administrators). • Must address changing demands of highly dynamic environment as work progresses (e.g., impact of budget cuts, reorganizations, changes of administration…. ) • Balance minimizing burden and maximizing sustainability. • Incorporate credible potential for cost offsets or savings (not a guarantee of buy-in but can help and increases sustainability. • Partnerships at multiple levels including states/service delivery systems with researchers; partnerships between states. • Engagement of stakeholders within states (clinical communities, multiple state agencies…)

26. Highlights • Utilizing data and quality collaboratives to translate payer-perceived problems (e.g., within-state variation) into shared problems. • Build consensus on practices and develop framework that supports measuring and monitoring those practices. • Don’t just give states a fish but try to provide fishing equipment. • What you cannot measure, you cannot manage. Improved utilization and integration of state data—multiple-purpose tool for decision support, tracking and monitoring progress, provider feedback, coordinated care management, and ability to evaluate outcomes of new service delivery system interventions.

27. Highlights • To increase uptake of evidence based practices, need structure of data, metrics, reporting/access, and followup to create feedback loops and “learning health care system”. This is a special challenge in mental health since these data especially likely to be fragmented into silos. Issues not just technical -- involve issues of control, “ownership”, confidentiality. • Fragmentation of data for dual eligibles has emerged as issue of concern—involves sharing data between levels of government. Federal policy moving in this direction but not there yet. Dual-eligibility an under-recognized problem for SMI. Duals Working Group created by popular request. • Data integration needs to increasingly incorporate clinical data --will raise even more challenging issues of control and ownership.

28. What are the Challenges that Confront Patient-Centered Outcomes Research on Service Delivery System Interventions for SMI? • DEcIDE protocol for integration serves as an example. • Improving the integration of general medical and behavioral health services – key challenge for public health services system . • Understanding “what works” takes on increased urgency in light of ACA and other health policy developments. What should a health home for person with SMI look like? What are outcomes of alternative approaches to care integration? • Topic addresses stakeholder concerns from 2010 Issues Exploration Forum and 2011 DEcIDE Mental Health Research Consortium’s Stakeholder Committee meeting. Stakeholders emphasized assessing mental health as well as general medical outcomes, and considering different patient subgroups within SMI population.

29. Health Homes for Persons with Chronic Conditions Under ACA • New financial incentives to states in ACA to develop health homes for multiple chronic conditions including SMI. Most states have initiated plans to implement such models but knowledge base is inadequate re effectiveness of alternative approaches. • ACA Section 2703 -- 90% FFP for specialized health homes for beneficiaries with chronic conditions, including SMI. Many states developing state plan amendments; need for info on effectiveness of alternative program configurations and strategies needed to guide implementation of these programs. • Eligibility: at least two chronic conditions, OR one chronic condition and at risk for another; OR have a serious and persistent mental health condition. Dual-eligibles cannot be excluded.

30. Services may include care coordination and health promotion, comprehensive transitional care from inpatient to other settings, including appropriate follow-up; individual and family support; referral to community and social support services, if relevant; use of health information technology (HIT) to link services. • States expected to track outcomes. Expected outcomes include reduced ER use, hospital admissions and re-admissions, overall cost reduction, less reliance on long-term care facilities, and improved experience of care and quality of care outcomes for the individual.

31. Research Questions • How do strategies, services, staffing, care protocols, and other aspects of care integration interventions vary across states and sites? How do outcomes for patients receiving these services compare to those for those served at sites without these services? • What is the effectiveness of various components and strategies of the care integration initiatives? • How do outcomes vary across subpopulations of special concern, such as those with substance abuse issues, those with particularly complex medical challenges, and those with particular mental health diagnoses?

32. Design Challenges • Assessing outcomes of these complex service delivery system interventions entails special challenges, vs. evaluation of specific alternative clinical treatments or devices. • Randomization at individual level typically infeasible, although cluster randomized designs may be feasible in some instances. • Defining and measuring “exposure” likely to be more challenging than in studies of clinical interventions; likely to be a key research task in its own right. • Care integration initiatives typically represent complex “bundles” of changes in such elements as staffing; services offered; policies, procedures, and care protocols; reimbursement; and other changes that will differ in multiple dimensions between service delivery systems and, within these systems, across sites. “When you’ve seen one state, you’ve seen one state.”

33. Design Challenges • Timing of intervention not under researcher’s control; interventions may already be in progress; changes may occur over time rather than on a single implementation date. • Different program elements may be implemented at different times; implementation of “new” initiatives may represent relabeling or extension of previous initiatives. • Meaningful interpretation of differences in implementation and outcomes across states or other service delivery systems will require significant contextual information on the systems and funding streams within which the initiatives are implemented; mental health service delivery structures are especially variable. • Collection of new clinical or patient-oriented data may be difficult if not built into routine program operations. Consistent followup in an SMI population may be challenging. • Balancing rigor and timeliness: can study be completed soon enough for anyone to care about the results?

34. Illustrative Approach • To address these challenges, a potential approach to assessing outcomes of health homes for SMI across states would be a consortium approach that extends stakeholder engagement to the conduct of the research as well as to the prioritization of research topics – described briefly below. • Under this approach, a consortium of states or other large service delivery systems would be formed to examine impact of differently configured health homes programs on care processes and outcomes, using collaborative, mixed-methods approach. Consortium would work with a coordinating center to select common outcome assessment measures and tools to characterize program elements and timing of their implementation in each state and at each site. Outcomes would be based mainly on existing data given timeliness considerations. Common outcome measures would include HEDIS/NQF measures of care processes for general medical conditions and mental health conditions; hospitalization and rehospitalization; and other measures calculable from administrative data common across sites. Some states may be able to include richer clinical and patient-reported data.

35. Illustrative Approach • Primary population of interest: individuals with schizophrenia, given the severe and long-term impact of this condition, with potential addition of those with bipolar. Since programs will generally be serving a broader population of adults with mental illness, cost of examining data on other patient subpopulations may not be great and examination and contrasting of outcomes in these subpopulations could be considered. • Sub-analyses would focus on SMI individuals with complex comorbidity. • Dual-eligibles would be included; Medicare A, B and D data on these beneficiaries would be requested from CMS and integrated with Medicaid, clinic, and other state-level data. • Stakeholder input indicates that cost impact of programs (for example, impact on use of inpatient and other high-cost services) will be important for sustainability; thus, impact on overall cost of care and use of specific high-cost services would be considered.

36. Illustrative Approach • Detailed characterization of program content, variations and timing of implementation would be a key initial objective. Contrasts across settings would be a key element of analysis: e.g;, how do outcomes compare for persons with SMI served in mental health specialty settings in which elements of primary care provision or coordination are introduced, versus those served in general medical care settings in which mental health services are being added. • Another key contrast: impact of on-site versus off-site provision of primary-care physician services; substance abuse services; and other service components. Organizational characteristics assessed by Center for Medical Home Improvement’s Medical Home Index: Adult and other common instruments. • Approach needs to accommodate the reality that many key aspects of interventions and available data will vary from state to state, while maintaining as much commonality of measurement as possible. Documenting the actual content of interventions will be a key aspect of the study and important in its own right.

37. Discussion: What Constitutes Adequate Evidencein Patient-Oriented Outcome Researchon Service Delivery System Interventions? • Definitions of CER and PCOR have been broadened to include systems interventions and outcomes of alternative methods to improve delivery of care. However, application to service delivery systems interventions will require addressing many challenges. What are criteria for “evidence”? Is it enough to reduce uncertainty on a question important to stakeholders? • Can we match standard of rigor applicable to clinical interventions? DEcIDE network is developing guidelines for DEcIDE protocols; how will such guidelines apply to service delivery system research?

38. Discussion: What Constitutes Adequate Evidencein Patient-Oriented Outcome Researchon Service Delivery System Interventions? • Would classification systems such as GRADE categorize this evidence as adequate? • If these large and complex system changes, which build on existing structures and past initiatives, cannot be exactly standardized, how effectively can one generalize from results? What will be the evidentiary status of mixed-methods studies? • As programs are modified over the years in response to initial experience, financial/reimbursement considerations and other factors, how well will earlier evidence apply?

39. Concluding Thoughts • How can we more effectively translate into practice existing evidence on service delivery systems in mental health, and build evidence on outcomes of new innovations? • Service delivery systems evolve in response to numerous influences; spread and evidence development both are best understood as ongoing efforts. • An essential tool for both is access to data; the capacity to transform data into useful information (e.g., metrics); integration of “siloed” data streams; and processes to make this information available to multiple users to support continuous quality improvement, feedback, tracking progress, and care management. States need support in building and utilizing this infrastructure. • Outcomes evaluation most likely to be effective if it is built into the design of new initiatives from the outset. Federal incentives can contribute to this effort. • Partnerships are key: across states; within states; between researchers and policymakers; and among the multiple payers and agencies involved in care of these vulnerable patients.

40. DATA SOURCES Medicaid Eligibility Files Medicaid MC Encounter Data Medicaid FFS Claims Medicare (A, B, D) State Children Services Data State Mental Health Agency Data Mental Health Carveouts (Managed Care, county, etc) DATA INTEGRATION DATA USERS State Mental Health Agencies State Children’s Services State Medicaid Agency Mental Health Clinics Other Providers/Prescribers Consumers