A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD & Comorbidity (UH2 MH )
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1 A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD & Comorbidity (UH2 MH ) Douglas Zatzick, MD Professor, Department of Psychiatry and Behavioral Sciences Harborview Level I Trauma Center University of Washington School of Medicine, Seattle
2 Trauma Survivors Outcomes & Support (TSOS) Trauma Surgery Policy Core Gregory Jurkovich Ron Maier David Hoyt
3 Trauma Survivors Outcomes & Support (TSOS) Bioinformatics Core Erik Van Eaton Cory Kelly Firoozeh Mehri-Kalandari
4 Trauma Survivors Outcomes & Support (TSOS) Biostatistics Core Patrick Heagerty Bryan Comstock Joan Russo Jin Wang
5 Trauma Survivors Outcomes & Support (TSOS) Other Collaborators Doyanne Darnell (Behavioral Interventions) Larry Palinkas (Implementation Science) Anurban Basu (Health Economics) Lauren Whiteside (Emergency Medicine) Jeff Love (Project Coordination)
6 Trauma Survivors Outcomes & Support (TSOS): Overview Background: US Trauma Care Systems Background: PTSD & Comorbidity Background: Policy Relevance UH3 Study Design & Implementation Dissemination Plan Questions & Discussion
7 Background: US Trauma Health Care Systems
8 Background: Injury Events & Trauma Care Systems 30 million US injury visits annually million injury admissions Over 1000 US trauma centers Level I trauma centers set standards nationally
9 US Trauma Care Systems: Care Coordination Paramedic/ Pre-Hospital Emergency & Trauma Center Primary Care and Community
10 US Trauma Care Systems: Unique Service Delivery Context Open entry of injured patients - Diverse health plans - No single administrative database Remarkable heterogeneity - Patient SES & ethnocultural diversity - Providers (MD, RN, MSW) - Information technology capacity
11 Background: Posttraumatic Stress Disorder (PTSD ) & Comorbidity Multiple Chronic Condition Framework
12 PTSD & Other Mental Health/Substance Disorders Among Randomly Selected Harborview Emergency/Trauma Surgery Patients (N=878) Zatzick Donovan Dunn Russo Wang Jurkovich et al JSAT 2012
13 PTSD & Comorbidity and the Multiple Chronic Condition Framework Mental health comorbidity: PTSD, depression and occult suicidal ideation (25-40%) Alcohol use problems (25%) Other substance use problems: Stimulants, opiates, benzodiazepines, MJ (20%) Chronic pain and somatic symptom amplification (10-20%) Traumatic Brain Injury (40-50%) Pre-injury chronic medical conditions (>50%)
14 Chronic Medical Condition Heterogeneity Among Admitted Injury Survivors (N = 76,942) Condition/System Percentage Hypertension 33% Heart Disease 24% Pulmonary 16% Diabetes 14% Renal 6% Hepatic 5% Obesity 5% Neoplasm 4%
15 Background: Prior Collaborative Care Trials Successfully Targeting PTSD & Comorbidity Alcohol use & recurrent injury (Annals of Surgery 1999) Alcohol use - 20 trauma center sites (Addiction 2014) Injury risk/weapon carrying (JAMA Pediatrics 2014) PTSD symptoms & Alcohol use (JAMA Psychiatry 2004) PTSD symptoms with IT enhanced collaborative care (Under revision) PTSD symptoms & improved physical function (Annals of Surgery 2013)
16 Background: Collaboratory Pragmatic Trial Methods - Research Partnerships
17 Implementation Science: Make It Happen Research to Policy Partnership with The American College of Surgeons (Greenhalgh et al 2004, Milbank Quarterly)
18 PTSD PTSD screening & intervention best practice guideline recommendation
19 US Trauma Care System Pragmatic Trial Generalizability Patient Provider Site (Trauma Center)
20 UH3 Research Plan
21 Trauma Survivors Outcomes & Support (TSOS) UH3 Aims 1) Conduct pragmatic trial 2) Understand trial implementation 3) Dissemination of results through Amer. College of Surgeons policy
22 UH3 Study Design Cluster randomized trial 24 US trauma centers Stepped wedge design All sites begin recruiting controls Intervention turned on at each site 40 patients per site (960 patients total) Baseline PTSD & comorbidity assessment 3, 6 and 12 month follow-up interviews
23 UH2-UH3 Hypotheses: Aim 1 The intervention group when compared to the control group will demonstrate: 1) PTSD symptoms (primary hypothesis) 2) Depressive symptoms 3) Alcohol use problems 4) Improved post-injury physical function Exploration of intervention effects in patients with/without chronic medical conditions & TBI Exploration of intervention effects on other conditions (e.g., chronic pain, drugs of abuse)
24 US Trauma Centers
25 Trauma Center Site Selection Criteria Exclude child trauma centers (age < 18) RFA: No research network Not currently routinely screening or intervening for PTSD (Exclude Innovators < 10% of US sites) Availability of Champions: - Trauma surgery - PTSD intervention - Information technology
26 CONSORT: Trauma Center Recruitment 225 US Level I Trauma Centers Contacted Excluded 19 Children s Hospitals 12 Prior Pragmatic Trial 105 Declined Assessment 89 Assessed for Participation 24 Enrolled 19 Declined After Assessment 13 Excluded PTSD Innovator 33 Waitlisted
27 TSOS US Level I Trauma Center Sites (N =24)
28 Comparison of Trauma Centers Participating in the Trial with Those Not Participating TSOS (n = 24) Others (n = 221) P US Region 0.16 Midwest 28.0% 32.5% South/SE 24.0% 14.2% Northeast/East 16.0% 32.5% West 16.0% 14.2% Central 16.0% 6.6% Rural 12.0% 12.2% 1.0 Teaching hospital 92% 82%% 0.27 Population served 0.02 Adult 28.0% 46.7% Adult & pediatrics 72.0% 41.1% Pediatrics 0.0% 11.7% Hospital beds (median)
29 Variability in TSOS Trauma Center Characteristics (N =24) PTSD prevalence - Violent injury admissions - ICU Recruitment rates - Trauma center admit volume Follow-up rates - Substance use - Homelessness
30 Stepped Wedge Design Sites recruit control & intervention 24 sites randomized to 4 waves Begin with control recruitment Turn on intervention midway
31 Stepped Wedge Cluster Randomized Design Patients Unexposed to intervention (n = 480) Patients Exposed to intervention (n= 480) Follow-up Period Wave 1 Wave 2 Wave 3 Wave 4 Accrual period n=8 n=32 n=16 n=24 n=24 n=16 n=32 n=8 Period 0 Period 1 Period 2 Period 3 Period 4 6 centers/wave x 40 patients = 960 patients Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Yr 1 Yr 2 Yr 3 Yr 4 Yr 5
32 Patient Flow Through UH3 Protocol Injury Admissions Age 18 Medical Record 10 Domain PTSD Risk Screen Exclude Acute Psychiatric Prisoners Non-English Speaking Postpone Cognitive Impairment Consent Administer PTSD Checklist PTSD Checklist 35 Exclude < 3 PTSD Risk Factors Exclude PTSD Checklist < 35 Cohort Definition PTSD Checklist 35
33 Medical Record 10 risk domain PTSD Evaluation
34 Cohort Definition: Patient Reported Outcome PTSD Checklist: 17 item DSM PTSD PTSD Checklist score 35 included All comorbidities included
35 Control Condition Usual trauma center care Infrequent PTSD intervention Poor trauma center to community linkage fragmented care common Inconsistent attention to comorbidity
36 Evidenced-based Intervention: Stepped Collaborative Care (6 mo.) Combined disease management - Care management - Pharmacotherapy - Motivational interview & CBT elements Multidisciplinary teams - Care management (MSW, RN) - Mental health providers (e.g., PhD) - Medical & surgical providers (MD)
37 Stepped Collaborative Care: Readily Implementable Elements Step I Empathic Engagement Care Coordination Trauma Center Outpatient Primary Care Linkage Time
38 Stepped Collaborative Care: Readily Implementable Elements Step II Medications PTSD & Comorbidity Step I Empathic Engagement Care Coordination Trauma Center Outpatient Primary Care Linkage Time
39 Stepped Collaborative Care: Readily Implementable Elements Step III Behavioral Intervention: Motivational Interview & Cognitive Behavioral Therapy Elements Step II Medications PTSD & Comorbidity Step I Empathic Engagement Care Coordination Trauma Center Outpatient Primary Care Linkage Time
40 Stepped Collaborative Care: Readily Implementable Elements Step IV Specialty Referral Step III Behavioral Intervention: Motivational Interview & Cognitive Behavioral Therapy Elements Step II Medications PTSD & Comorbidity Step I Empathic Engagement Care Coordination Trauma Center Outpatient Primary Care Linkage Time
41 Stepped Collaborative Care: Readily Implementable Elements Step V Community Integration Step IV Specialty Referral Step III Behavioral Intervention: Motivational Interview & Cognitive Behavioral Therapy Elements Step II Medications PTSD & Comorbidity Step I Empathic Engagement Care Coordination Trauma Center Outpatient Primary Care Linkage Time
42 Intervention Training Front-line trauma providers 1 day on-site trauma center training Ongoing feedback and coaching using TSOS decision support tool
43 Trauma Center IT Considerations
44 The Informatics Goal Leverage site IT capacity for trauma patient data extraction
45 The Informatics Goal Provide a real-time, workflowintegrated decision support tool
46 The Informatics Goal Align to existing methods for distributed research networking
47 The Informatics Challenge: Infrastructure Variability
48 Solution: Flexibility, and
49 Structure
50 Structure
51 Blinded Assessments 3-, 6- & 12-months Post-injury: Patient Reported Outcomes PTSD (PTSD Checklist) Depression (PHQ-9) Alcohol use problem (AUDIT) Physical function (SF-36 PCS) Anticipated 75-80% 12-month f/u
52 Analyses Intervention vs. Control Comparisons - PTSD (Primary) - Alcohol - Depression - Physical function - Pre-injury Medical Conditions (ICD) - Traumatic brain injury (ICD) Health economic assessment RE-AIM assessment of implementation and sustainability
53 Dissemination Year 5 American College of Surgeons Policy Summit
54 PTSD PTSD screening & intervention best practice guideline recommendation
55 PTSD PTSD screening & intervention best practice guideline recommendation Patient Reported Outcome 17 item PTSD Checklist Recommended
56 Next Steps The incorporation of routine trauma center based screening and intervention for PTSD and depression is an area that could benefit from the ongoing integration of emerging data and evolving expert opinion
57 Questions & Discussion
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