Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants.

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team's experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.

Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial.

OBJECTIVE: The investigation aimed to compare two approaches to the delivery of care for hospitalized injury survivors, a patient-centered care transition intervention versus enhanced usual care. METHOD: This pragmatic comparative effectiveness trial randomized 171 acutely injured trauma survivors with three or more early postinjury concerns and high levels of emotional distress to intervention (I; n = 85) and enhanced usual care control (C; n = 86) conditions. The care transition intervention components included care management that elicited and targeted improvement in patients' postinjury concerns, 24/7 study team cell phone accessibility, and stepped-up care. Posttraumatic concerns, symptomatic distress, functional status, and statewide emergency department (ED) service utilization were assessed at baseline and over the course of the 12 months after injury. Regression analyses assessed intervention and control group outcome differences over time. RESULTS: Over 80% patient follow-up was attained at each time point. Intervention patients demonstrated clinically and statistically significant reductions in the percentage of any severe postinjury concerns expressed when compared to controls longitudinally (Wald chi-square = 11.29, p = 0.01) and at the six-month study time point (C = 74%, I = 53%; Fisher's exact test, p = 0.02). Comparisons of ED utilization data yielded clinically significant cross-sectional differences (one or more three- to six-month ED visits; C = 30.2%, I = 16.5%, [relative risk (95% confidence interval] C versus I = 2.00 (1.09, 3.70), p = 0.03) that did not achieve longitudinal statistical significance (F (3, 507) = 2.24, p = 0.08). The intervention did not significantly impact symptomatic or functional outcomes. CONCLUSIONS: Orchestrated investigative and policy efforts should continue to evaluate patient-centered care transition interventions to inform American College of Surgeons' clinical guidelines for U.S. trauma care systems.

The Cumulative Burden of Mental, Substance Use, and General Medical Disorders and Rehospitalization and Mortality After an Injury.

OBJECTIVE: Each year in the United States, 1.5-2.5 million individuals require hospitalization for an injury. Multiple mental, substance use, and chronic general medical disorders are endemic among injury survivors with and without traumatic brain injury (TBI), yet few studies have assessed the association between the cumulative burden of these conditions and health care outcomes. This study of patients hospitalized for an injury assessed associations between comorbid mental, substance use, and general medical disorders, TBI, and violent events or suicide attempts and the postinjury outcomes of recurrent hospitalization and death. METHODS: Recurrent hospitalization and all-cause mortality were examined in this population-based retrospective cohort study. A total of 76,942 patients hospitalized for an injury in Washington State during 2006-2007 were followed for five years. ICD-9-CM codes identified conditions prior to or at the index injury admission. Index admissions related to injuries from firearms, assaultive violence, suicide attempts, and overdoses were identified through E-codes. RESULTS: Adjusted regression analyses demonstrated a significant, dose-response relationship between an increasing cumulative burden of disorders and an increasing risk of recurrent hospitalization (four or more conditions, relative risk=3.89, 95% confidence interval [CI]=3.66-4.14). Adjusted Cox proportional hazard regression demonstrated a similar relationship between increasing cumulative burden of disorders and all-cause mortality (four or more conditions, hazard ratio=5.33, CI=4.71-6.04). CONCLUSIONS: Increasing cumulative burden of disorders was associated with greater postinjury risk of recurrent hospitalization and death. Orchestrated investigative and policy efforts could introduce screening and intervention procedures that target this spectrum of comorbidity.

Enhancing the Reach of Cognitive-Behavioral Therapy Targeting Posttraumatic Stress in Acute Care Medical Settings.

OBJECTIVE: Injured patients presenting to acute care medical settings have high rates of posttraumatic stress disorder (PTSD) and comorbidities, such as depression and substance use disorders. Integrating behavioral interventions that target symptoms of PTSD and comorbidities into the acute care setting can overcome common barriers to obtaining mental health care. This study examined the feasibility and acceptability of embedding elements of cognitive-behavioral therapy (CBT) in the delivery of routine postinjury care management. The investigation also explored the potential effectiveness of completion of CBT element homework that targeted PTSD symptom reduction. METHODS: This study was a secondary analysis of data from a U.S. clinical trial of the effectiveness of a stepped collaborative care intervention versus usual care for injured inpatients. The investigation examined patients' willingness at baseline (prerandomization) to engage in CBT and pre- and postrandomization mental health service utilization among 115 patients enrolled in the clinical trial. Among intervention patients (N=56), the investigation examined acceptability of the intervention and used multiple linear regression to examine the association between homework completion as reported by the care manager and six-month PTSD symptom reduction as assessed by the PTSD Checklist-Civilian DSM-IV Version. RESULTS: Patients in the intervention condition reported obtaining significantly more psychotherapy or counseling than patients in the control group during the six-month follow-up, as well as a high degree of intervention acceptability. Completion of CBT element homework assignments was associated with improvement in PTSD symptoms. CONCLUSIONS: Integrating behavioral interventions into routine acute care service delivery may improve the reach of evidence-based mental health care targeting PTSD.

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.

A Randomized Evaluation of Motivational Interviewing Training for Mandated Implementation of Alcohol Screening and Brief Intervention in Trauma Centers.

The American College of Surgeons has mandated that level I and level II trauma centers implement universal alcohol screening and brief intervention (SBI) for injured patients. This study was a secondary analysis of a national, 20-hospital, cluster-randomized implementation trial focusing on practical issues of training and supervising alcohol SBI providers in motivational interviewing (MI). The purpose of this study was to examine whether real-world trauma center providers can be trained to provide higher quality counseling using MI as part of brief interventions for alcohol and whether MI skills can be maintained over time. Sites were randomly assigned to receive a 1day workshop training in MI for alcohol SBI or not, and all providers regardless of training completed up to seven standardized patient assessments of MI fidelity over 27months. Six domains on the Motivational Interviewing Treatment Integrity (MITI) coding system were assessed and compared to proficiency criteria. Providers in the intervention training group showed substantially improved MITI scores over the course of the 27-month time period. Domains that had particularly strong improvement were MI spirit and empathy; however, despite the overall improvement in the intervention group scores, expert-derived proficiency criteria were attained only for the global scores. Routine trauma center providers who receive MI training can deliver higher quality counseling in alcohol brief interventions, but may not, however, attain previously derived proficiency standards. Future implementation efforts in real-world acute care medical settings could further elucidate provider characteristics that predict training response and also strive to demonstrate that higher quality alcohol SBI implementation is associated with improved patient-level outcomes.

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury.

Traumatic Life Events Prior to Alcohol-Related Admission of Injured Acute Care Inpatients: A Brief Report.

OBJECTIVE: Approximately 30 million Americans present to acute care medical settings annually after incurring traumatic injuries. Posttraumatic stress disorder (PTSD) and depressive symptoms are endemic among injury survivors. Our article is a replication and extension of a previous report documenting a pattern of multiple traumatic life events across patients admitted to Level I trauma centers for an alcohol-related injury. METHOD: This study is a secondary analysis of a nationwide 20-site randomized trial of an alcohol brief intervention with 660 traumatically injured inpatients. Pre-injury trauma history was assessed using the National Comorbidity Survey trauma history screen at the six-month time point. RESULTS: Most common traumatic events experienced by our population of alcohol-positive trauma survivors were having had someone close unexpectedly die, followed by having seen someone badly beaten or injured. Of particular note, there is high reported prevalence of rape/sexual assault, and childhood abuse and neglect among physically injured trauma survivors. Additional trauma histories are increasingly common among alcohol-positive patients admitted for a traumatic injury. CONCLUSIONS: Due to the high rate of experienced multiple traumatic events among acutely injured inpatients, the trauma history screen could be productively integrated into screening and brief intervention procedures developed for acute care settings.

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.