An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity

Zatzick et al. Implementation Science (2016) 11:58 DOI 10.1186/s13012-016-0424-4 STUDY PROTOCOL Open Access An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity Douglas F. Zatzick1,5*, Joan Russo1, Doyanne Darnell1, David A. Chambers2, Lawrence Palinkas3, Erik Van Eaton4, Jin Wang5, Leah M. Ingraham1, Roxanne Guiney1, Patrick Heagerty6, Bryan Comstock6, Lauren K. Whiteside7 and Gregory Jurkovich8 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/design: 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 motivationalinterviewing 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. (Continued on next page) * Correspondence: 1 Department of Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Ave, Box 359911, Seattle, WA 98104, USA 5 Harborview Injury Prevention Research Center, University of Washington, 325 Ninth Ave, Box 359960, Seattle, WA 98104, USA Full list of author information is available at the end of the article © 2016 Zatzick et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Zatzick et al. Implementation Science (2016) 11:58 Page 2 of 16 (Continued from previous page) Discussion: 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. Trial registration: ClinicalTrials.gov NCT02655354. Registered 27 July 2015. Keywords: Traumatic injury, Multiple chronic conditions, Posttraumatic stress disorder, Depression, Suicidal ideation, Substance abuse, Effectiveness-implementation hybrid, Pragmatic clinical trial, American College of Surgeons, Policy Background The overarching goal of the trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid clinical trial is to develop and implement a large scale, cluster randomized pragmatic demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidity. Physical injury occurs frequently in the USA and constitutes both a substantial source of individual suffering and a significant public health burden. Each year in the USA, over 30 million individuals present to acute care medical trauma center and emergency department settings for the treatment of traumatic physical injury [1–5]. Injured trauma survivors present to acute care medical settings after both intentional (e.g., gunshots, stabbings, physical assaults) and unintentional (natural disasters, motor vehicle crashes) injury events [6]. Annually, 1.5–2.5 million Americans are so severely injured that they require inpatient hospitalization [1–5]. Estimates suggest that approximately 1.5 million American youth and adults experience traumatic brain injury (TBI) annually [7, 8]. Physical injury with and without TBI constitutes a major public health problem for both civilian and veteran patient populations [9, 10]. Globally, traumatic injury accounts for approximately 16 % of the world’s burden of disease [11–13]. Multiple chronic conditions appear to be endemic among physical trauma survivors treated in US trauma care systems [14–16]. Recent commentary has explicated chronic conditions as conditions that last 1 year or more and require ongoing medical attention and/or limit activities of daily living [17–19]. Highly prevalent comorbidities include enduring PTSD, depression, and associated suicidal ideation, alcohol, and drug use problems, TBI, and chronic medical conditions such as hypertension, coronary artery disease, diabetes, and pulmonary disease [14, 20, 21]. Evidence-based, collaborative care intervention models for PTSD and related comorbidities exist [16, 22–25]. Collaborative care treatment models however, have yet to be broadly implemented throughout US trauma care systems; prior investigation by members of the interdisciplinary study team suggest that less than 10 % of US trauma centers routinely provide post-injury screening or integrated care management treatment targeting the cluster of PTSD and related comorbidities [26]. The enduring challenges presented by the chronic disease cluster of PTSD and comorbidities aft (...truncated)