connecting research and policy in early psychosis treatment...systematic analysis of...
TRANSCRIPT
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Connecting Research and Policy in Early Psychosis Treatment
Robert K. Heinssen, Ph.D., ABPP Early Psychosis Prevention and Early Intervention: Science Informing Policy Symposium Sacramento, CA
17 September 2015
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• I have no personal financial relationships with commercial interests relevant to this presentation
• The views expressed are my own, and do not necessarily represent those of the NIH, NIMH, or the Federal Government
Disclosures
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17 year odyssey from discovery to practice
Research Synthesis
Treatment Guidelines
Publication Priorities
Scientific Discovery ≠ Uptake
Translational Pipeline
Basic Science
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Ross Brownson et al., 2006, American Journal of Preventive Medicine
Research and Policy Disconnect Scientific decision making Policy decision making
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Hybrid Decision Making Model
Agree on key research and policy
questions
Identify the public health problem
Agree on study design, dependent variables
Conduct study
Maintain support and accountability
Use data to inform policy decisions
High Impact Research
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Case Study
The “Recovery After an Initial Schizophrenia Episode” initiative seeks to fundamentally alter the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness.
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Step 1
Identify the public health problem
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Established Schizophrenia
• ~2.5 million adults in U.S. are affected
• Onset typically in late adolescence, early 20s
• High morbidity and mortality — Multiple episodes of psychosis over the lifetime — High unemployment, homelessness, incarceration — Shortened lifespan (suicide, medical co-morbidities)
• Economic cost of $62.7 billion in 2002 — Direct health care costs of $22.7 billion
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Rapid remission of positive symptoms
Lower rates of psychiatric re-hospitalization
Decreased substance use
Improved social and vocational functioning
Increased quality of life
Early Intervention Matters
Ryan
http://practiceinnovations.org/ConsumersandFamilies/ViewAllContent/tabid/232/Default.aspx
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11
Coordinated Specialty Care Model
Client
Medication/ Primary Care
Psychotherapy
Family Education and
Support
Supported Employment
and Education
Case Management
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Step 2
Agree on key research and policy questions
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First Episode Psychosis
Consumers, Relatives,
Policy Makers
Phase-Specific
Interventions
Can coordinated specialty care, offered early on,
improve long term-outcomes for schizophrenia in the US?
Disability in Schizophrenia
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Step 3
Agree on study design and dependent variables
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Comparative effectiveness trial
Implementation study — Lisa Dixon — Susan Essock — Howard Goldman
— John Kane — Nina Schooler — Delbert Robinson
NIMH RAISE Projects
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U.S. Federal Stakeholders Dependent Variables
Substance Abuse and Mental Health Services Administration (SAMHSA) Recovery, functioning, quality of life
National Institute of Drug Abuse (NIDA) Substance abuse, tobacco dependence
Centers for Medicare and Medicaid Services (CMS)
Psychiatric relapse, re-hospitalization, cost of medical and specialty care
Social Security Administration (SSA) School completion, early vocational milestones, competitive employment
Policy Makers’ Interests
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Brokering Agreement on Measures
“The Social Security Administration figures its annual budget in terms of U.S. dollars,
not Quality Adjusted Life Years.”
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Step 4
Conduct study
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■ Phase-specific specialty care for First Episode Psychosis vs. TAU ■ Representative patients (N=404) and community clinics (N=34) ■ Focus on clinical and functional recovery, cost of care, societal benefits
TX
UT
MT
CA
AZ
ID
NV
OR
IA
CO KS
WY
NM
MO
MN
NE
OK
SD
WA
AR
ND
LA
IL OH
FL
GA AL
WI
VA
IN
MI
MS
KY
TN
PA
NC
SC
WV
NJ
ME
NY
VT
MD
NH
DE
MA RI
RAISE Clinical Trial
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State Officials as Research Partners
“Turn Key” Solutions for State Administrators
RAISE Implementation Study
NYS Office of Mental Health MD Mental Hygiene Administration
Training and supervising existing staff Assertive outreach and client engagement
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Step 5
Maintain stakeholder support, promote accountability
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Instill productive urgency
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Early Data from Clinical Trial
<5% of FEP patients with cardio-metabolic risk factors receive appropriate medical care Correll et al., 2014, JAMA Psychiatry
Median duration of untreated psychosis is 74 weeks in community clinic settings Addington et al., 2015, Psychiatric Services
Only 61% of FEP patients receive medications in line with PORT recommendations Robinson et al., 2014, American Journal of Psychiatry
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Engineer accountability
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NIMH Engagement Activities SAMHSA
SSA
NIDA ASPE
CMS
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2008 - 2010
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NIMH Engagement Activities SAMHSA
ASPE
CMS/CMMI
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
SSA
2011 - 2012
Center for Medicare & Medicaid Innovation NIDA
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NIMH Engagement Activities SAMHSA
NIDA ASPE
CMS/CMMI
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
SSA
2011 - 2012
Sandy Hook Elementary
School Shooting
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NIMH Engagement Activities SAMHSA
SSA
NIDA ASPE
CMS/CMMI
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2013 - 2014
Post-Sandy Hook Interest in Early SMI
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NIMH Engagement Activities SAMHSA
SSA
NIDA ASPE
CMS/CMMI
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2013 - 2014
U.S. Congress
Mental Health Advocacy Groups
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Step 6
Use data to inform policy decisions
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Early Actions from Implementation Study
RAISE OnTrackNY
RAISE Maryland Early Intervention Program
NYS Office of Mental Health 4 new clinics for FEP June 2013
MD Mental Hygiene Administration 4 new clinics for FEP/CHR October 2013
■ In both cases, state officials accepted feasibility data before articles were accepted for publication!
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■ Phase-specific specialty care for First Episode Psychosis vs. TAU ■ Representative patients (N=404) and community clinics (N=34) ■ Focus on clinical and functional recovery, cost of care, societal benefits
TX
UT
MT
CA
AZ
ID
NV
OR
IA
CO KS
WY
NM
MO
MN
NE
OK
SD
WA
AR
ND
LA
IL OH
FL
GA AL
WI
VA
IN
MI
MS
KY
TN
PA
NC
SC
WV
NJ
ME
NY
VT
MD
NH
DE
MA RI
RAISE Clinical Trial
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Impact of Coordinated Specialty Care
CSC participants remain in treatment longer
CSC improves outcomes over 24 months
─ overall quality of life ─ measures of symptoms ─ interpersonal relations ─ involvement in work or school
Participants with shorter duration of untreated psychosis derive substantially more benefit from CSC
Kane et al., in press, American Journal of Psychiatry
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Do the right things, at the right time.
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Congressional Action
2008 2009 2010 2011 2012 2013 2014
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2013 - 2014
U.S. Congress
Consolidated Appropriations Act of 2014
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H.R. 3547, 113th Congress
37
■ Increased Community Mental Health Block Grant (CMHBG) program by $24.8M
■Funds allocated for first episode psychosis (FEP) programs
■NIMH and SAMHSA to develop guidance for States regarding effective programs for FEP
January 17, 2014
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• Evidence-based Treatments for First Episode Psychosis: Components of Coordinated Specialty Care
• RAISE Coordinated Specialty Care for First Episode Psychosis Manuals
• RAISE Early Treatment Program Manuals and Program Resources
• OnTrackNY Manuals & Program Resources • Voices of Recovery Video Series
http://www.nimh.nih.gov/health/topics/schizophrenia/raise/coordinated-specialty-care-for-first-episode-psychosis-resources.shtml
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Corey – Another Door Opens
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Potential Impact of H.R. 3547
TX
UT
MT
CA
AZ
ID
NV
OR
IA
CO KS
WY
NM
MO
MN
NE
OK
SD
WA
AR
ND
LA
IL OH
FL
GA AL
WI
VA
IN
MI
MS
KY
TN
PA
NC
SC
WV
NJ
ME
NY
VT
MD
NH
DE
MA RI
AK
HI
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Innovators and Early Adopters, 2013
TX
UT
MT
CA
AZ
ID
NV
OR
IA
CO KS
WY
NM
MO
MN
NE
OK
SD
WA
AR
ND
LA
IL OH
FL
GA AL
WI
VA
IN
MI
MS
KY
TN
PA
NC
SC
WV
NJ
ME
NY
VT
MD
NH
DE
MA RI
AK
HI
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Early Majority, 2015
TX
UT
MT
CA
AZ
ID
NV
OR
IA
CO KS
WY
NM
MO
MN
NE
OK
SD
WA
AR
ND
LA
IL OH
FL
GA AL
WI
VA
IN
MI
MS
KY
TN
PA
NC
SC
WV
NJ
ME
NY
VT
MD
NH
DE
MA RI
AK
HI
32 States ~120 Clinics
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Early Services S-Curve
0
10
20
30
40
50
2000 2003 2005 2008 2010 2013 2015 2018 2020 2023 2025 2030
States with CSC Plans
How do we sustain momentum?
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Beyond RAISE:
Creating an early psychosis learning community in the United States
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Early Psychosis Intervention Network (EPINET)
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Practice-based research model
Common data elements, data sharing, big data analytics
Feedback loops for ongoing system improvement
Culture of continuous learning
Clinical data drive scientific discovery
FY2015
Strategic Objective 4 – Learning Healthcare Systems
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EPINET Goals
Establish a national learning healthcare network among early psychosis clinics
Standardize measures of clinical characteristics, interventions, and early psychosis outcomes
A Adopt a unified informatics approach to study variations in treatment quality, clinical impact, and value
Cultivate a culture of collaborative research participation in academic and community early psychosis clinics
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How can EPINET improve treatment?
• Fidelity to CSC model
• Monitor key outcomes
• Continuous quality improvement
• Evaluate rare events with statistical power
• Rapid piloting or fielding of new approaches
http://nhqrnet.ahrq.gov/snaps11/dashboard.jsp?menuId=4&level=0&state=FL
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Who has a stake in EPINET?
8,000 Clients 5,000 Relatives
500 Clinicians
50 State MHPDs
SAMHSA NIMH CMS
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CA Early Psychosis Research Programs
2001
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Early Psychosis Research Clinics
2005
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Research-Informed EP Community Clinics
2012-2014
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EPIC-CAL??
(Early Psychosis Intervention Consortium of California)
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1 Brownson et al., 2006, American Journal of Preventive Medicine
Take Home Messages • Scientists and policymakers often travel in “parallel
universes1”
• Bridging this gap requires active engagement to find common interests, shared goals, and meaningful outcome measures
• Time matters – convey “productive urgency” to scientists; help policy makers see beyond immediate needs
• Recognize that stakeholders come and go, so talk to everyone, all the time.
• Big data may help us to improve the quality of care and drive scientific discoveries