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

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 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. 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.

Exploring the longitudinal trajectories of posttraumatic stress disorder in injured trauma survivors.

OBJECTIVE: The goal of this study was to examine the longitudinal trajectories of posttraumatic stress disorder (PTSD) symptoms in a sample of acutely injured hospitalized civilian trauma survivors who participated in a randomized clinical trial. Prior longitudinal descriptive research has shown that there are distinct trajectories of PTSD symptoms over time in trauma survivors. Limited clinical trial research exists that describes the patterns of the trajectories as well as the risk factors that influence the trajectories for seriously injured trauma-exposed patients. METHOD: Semiparametric, group-based approach trajectory modeling was used to examine four group trajectories of a subset of data obtained from a previous longitudinal clinical trial. Trajectories examined included resilience, recovery, relapsing/remitting, and chronic symptom patterns. One hundred and ninety-four patients who participated in the randomized clinical trial were assessed at baseline in the days and weeks after injury and then randomized. The associations between previously identified PTSD risk factors and the four trajectories were examined. RESULTS: The risk factors of ethnocultural minority status, psychiatric history, additional life stressors, and depressive symptoms, as well as intervention versus control group status, were found to significantly affect the probability of trajectory group membership for PTSD symptom severity. CONCLUSIONS: These findings suggest that there is a need for early PTSD interventions that anticipate differences in injured patients' PTSD trajectory profiles. Stepped care intervention procedures may optimally address the diverse PTSD trajectory patterns observed in injured trauma survivors through the tailoring of intervention timing and dosing.