Effective healthcare program initiatives in future CER/PCOR in mental health September 19, 2011 AHRQ Annual Conference Sonia Tyutyulkova, MD, PhD Center for Outcomes and Evidence, AHRQ

Stakeholder Engagement Group Scientific Resource Center RTI International-University of North Carolina Evidence-based Practice Center  Shannon Brode, MPH  Daniel E. Jonas, MD, MPH  Alyssa J. Mansfield, MPH, PhD  Brian B. Sheitman, MD  Elizabeth Tant  Meera Viswanathan, PhD  Lea C. Watson, MD, MPH DEcIDE Mental Health Consortium Coordinating Center  Stephen Crystal  Tobias Gerhardt  Sheree Nessee-Todd  Mark Olfson  Harold Pincus  Teresa Viggiano

Comparative Effectiveness Research “CER is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings.” “The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians and other decision makers responding to their needs.”

Patient-Centered Outcomes Research  Assesses the benefits and harms of preventive, diagnostic, therapeutic, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people;  Is inclusive of an individual's preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life;  Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination;  Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives.

Effective Health Care Program  Created in 2005, authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003  To improve the quality, effectiveness, and efficiency of health care delivered through Medicare, Medicaid, and S-CHIP programs  Focus on  Clinical effectiveness  Comparative Effectiveness

Effective Healthcare Program Structure

Raphael, , The School of Athens, Fresco, Apostolic Palace, Rome, Vatican City Stakeholder Driven Research

Series of Stakeholder Meetings

ProcessProcess

Rene Magritte ( ), Ceci n’est pas une pipe (1926) Need to Fundamentally Change Our Approach to Clinical Research for Serious Mental Illness

 Measurements and outcomes need consensus definitions.  Measurements and outcomes need consensus definitions. Develop measurements and outcome assessment tools that are based on a chronic care model rather than the inadequate metrics that exist today that are based on an acute-care model.  Development of infrastructure that supports longitudinal studies  Development of infrastructure that supports longitudinal studies and facilitate development of comparable datasets (detailed registries).  Development of CER methodology. Stakeholder Identified Priorities in SMI

Service delivery, treatment settings, and structuring the delivery of care Make treatment settings and service delivery systems into experiments for studies such as: (a) comparing the effectiveness of different systems for structuring the delivery of care, such as psychiatric medical homes vs. usual care; (b) comparing how variation across settings, systems, and states impacts disparities for specific groups; (c) state-to-state or smaller area comparisons; (d) public systems vs. various models of private insurance; (e) systems that deliver care in teams vs. those settings that deliver care in solo‐health‐practitioner or split-care arrangements; (f) delivery tools, such as prior authorization, and their impact; and (g) ethnic specific provider supports.

 Identify disparities and reasons for disparities and reevaluate the framework for researching disparities.  Role of the therapeutic relationship.  Strategies to personalize/individualize treatment.  Treatment approaches to avoid early mortality and morbidity.  Role of the psychiatric hospital, lengths of stay, and transition support services after discharge.  Retooling Universities and Education.  Strategies to increase adherence to evidence-based guidelines and treatment regimens.  Correctional programs and interventions for people involved with the criminal justice system.  Interventions for people with comorbid medical illness or substance abuse.  Prevention, early identification, trajectories, and developmental perspective.  Dissemination and implementation.  Reducing barriers and improving access.  Mental health policy.  Modifiable factors: tobacco, exercise, and nutrition.  Alternatives to force or involuntary approaches.  Providing housing or social support.  Strategies to reduce stigma, prejudice, and discrimination. Stakeholder Identified Priorities in SMI

System and Care Delivery Interventions

Systematic Reviews and Clinical Practice Guidelines

Effective Health Care Program Guides PolicymakersCliniciansConsumers

Evidence-based Practice Centers (EPC) Evidence Reports Antipsychotics  Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics Antipsychotics  Comparative Effectiveness of First- and Second-Generation Antipsychotics for Children and Young Adults  Antipsychotics  Antipsychotics in Adults: Comparative Effectiveness of First-Generation versus Second-Generation Medications Antidepressants  Comparative Effectiveness of Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression  Non-Pharmacologic Interventions  Non-Pharmacologic Interventions for Treatment-resistant Depression in Adults

Evidence-based Practice Centers (EPC) Evidence Reports  Effectiveness of Practice-based Interventions Addressing Concomitant Mental Health and Chronic Medical Conditions in the Primary Care Setting  Comparison of Characteristics of Nursing Homes and Other Residential Long- Term Care Settings for Persons with Dementia  Treatment Approaches to Avoid Early Morbidity and Mortality in Serious Mental Illness

The Evidence Landscape

Patient-Centered Outcomes Research “How can the health care system improve my chances of achieving the outcomes I prefer?”

Stakeholder Identified Priorities DEcIDE Network  Application and Effectiveness of Quality Measurement and Improvement Strategies to Enhance Care Processes and Outcomes for Individuals with Mental Illnessevidence-concordant measurement processes and measures  Application and Effectiveness of Quality Measurement and Improvement Strategies to Enhance Care Processes and Outcomes for Individuals with Mental Illness. What evidence-concordant measurement processes and measures are most appropriate and effective in assessing mental health care and its quality in various settings and plan arrangements?  Integration of General Medical and Behavioral Health Care for Adults with Severe Mental Illness  Improving Mental Health Care Continuity and Transitions for Adults with Severe Mental Illness traditional versus technologically enhanced methods  What is the comparative effectiveness traditional versus technologically enhanced methods (e.g., tele-medicine, computer programs, web-based systems, smart phones, etc.) in delivering evidence-based treatments ?  Structuring Care Delivery at the Provider Level. T  Structuring Care Delivery at the Provider Level. To what extent will functional outcomes differ for patients seen by clinicians:  with varying frequencies of visits, for varying lengths of office visits, and varying ease of access to clinicians?  In relation to characteristics of the provider and other individual and relationship factors. identifying individuals who are at high risk suicidereduce the risk of completed suicide  What approaches are most effective in identifying individuals with SMI or SED who are at high risk of suicide and of intervening to reduce the risk of completed suicide?