title: An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity.
abstract: BACKGROUND
  Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.
  
  
  METHODS
  The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.
  
  
  CONCLUSIONS
  The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02655354 . Registered 27 July 2015.
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA, 98104, USA. dzatzick@uw.edu.|Harborview Injury Prevention Research Center, University of Washington, 325 Ninth Ave, Box 359960, Seattle, WA, 98104, USA. dzatzick@uw.edu.
authors.forename: Douglas F
authors.initials: DF
authors.lastname: Zatzick
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA, 98104, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Russo
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA, 98104, USA.
authors.forename: Doyanne
authors.initials: D
authors.lastname: Darnell
authors.affiliation: Division of Cancer Control and Population Sciences, National Cancer Institute, BG 9609 MSC 9760, 9609 Medical Center Drive, Bethesda, MD, 20892-9760, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Chambers
authors.affiliation: School of Social Work, University of Southern California, Montgomery Ross Fisher Building, Room 339, Los Angeles, CA, 90089, USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Palinkas
authors.affiliation: Department of Surgery, University of Washington, 325 Ninth Ave, Box 359796, Seattle, WA, 98104, USA.
authors.forename: Erik
authors.initials: E
authors.lastname: Van Eaton
authors.affiliation: Harborview Injury Prevention Research Center, University of Washington, 325 Ninth Ave, Box 359960, Seattle, WA, 98104, USA.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA, 98104, USA.
authors.forename: Leah M
authors.initials: LM
authors.lastname: Ingraham
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA, 98104, USA.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Guiney
authors.affiliation: Department of Biostatistics, University of Washington, 1705 NE Pacific St, Box 357232, Seattle, WA, 98195, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.affiliation: Department of Biostatistics, University of Washington, 1705 NE Pacific St, Box 357232, Seattle, WA, 98195, USA.
authors.forename: Bryan
authors.initials: B
authors.lastname: Comstock
authors.affiliation: Division of Emergency Medicine, University of Washington, 25 Ninth Ave, Box 359702, Seattle, WA, 98104, USA.
authors.forename: Lauren K
authors.initials: LK
authors.lastname: Whiteside
authors.affiliation: Department of Surgery, University of California in Davis, 2221 Stockton Blvd, Cypress #3111, Sacramento, CA, 95817, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Jurkovich
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D015928:Cognitive Behavioral Therapy; D015897:Comorbidity; D003299:Cooperative Behavior; D005260:Female; D006284:Health Plan Implementation / Q000379:methods*; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000150:complications / Q000628:therapy; D062405:Motivational Interviewing; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome
keywords: American College of Surgeons; Depression; Effectiveness-implementation hybrid; Multiple chronic conditions; Policy; Posttraumatic stress disorder; Pragmatic clinical trial; Substance abuse; Suicidal ideation; Traumatic injury