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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
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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
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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
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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
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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
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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
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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
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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
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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.