Can Baseline Patient Clinical and Demographic Characteristics Predict Response to Early Posttraumatic Stress Disorder Interventions After Physical Injury?

OBJECTIVE: A growing evidence base supports stepped care interventions for the early treatment of posttraumatic stress disorder (PTSD) after physical injury. Few investigations have examined the characteristics of patients who do and do not respond to these interventions. METHOD: This investigation was a secondary analysis that used previously collected data from three randomized clinical trials of stepped care interventions (patient N = 498). The study hypothesized that a subgroup of patients would manifest persistent PTSD symptoms regardless of randomization to intervention or control conditions, and that characteristics present at the time of baseline injury hospitalization could distinguish patients who would develop persistent symptoms from potential treatment responders. Regression analyses identified baseline patient clinical and demographic characteristics that were associated with persistent PTSD symptoms over the 6-months post-injury. Additional analyses identified treatment attributes of intervention patients who were and were not likely to demonstrate persistent symptoms. RESULTS: A substantial subgroup of patients (n = 222, 44.6%) demonstrated persistent PTSD symptoms over time. Greater numbers of pre-injury trauma, pre-injury PTSD symptoms, elevated early post-injury PTSD symptoms, unemployment, and non-White race identified patients with persistent symptoms. Patients with ≥3 of these baseline risk characteristics demonstrated diminished treatment responses when compared to patients with <3 characteristics. Intervention patients with ≥3 risk characteristics were less likely to engage in treatment and required greater amounts of interventionist time. CONCLUSIONS: Injured trauma survivors have readily identifiable characteristics at the time of hospitalization that can distinguish responders to PTSD stepped care interventions versus patients who may be treatment refractory.

Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors?

Objectives: No large-scale randomized clinical trial investigations have evaluated the potential differential effectiveness of early interventions for post-traumatic stress disorder (PTSD) among injured patients from racial and ethnic minority backgrounds. The current investigation assessed whether a stepped collaborative care intervention trial conducted at 25 level I trauma centers differentially improved PTSD symptoms for racial and ethnic minority injury survivors. Methods: The investigation was a secondary analysis of a stepped wedge cluster randomized clinical trial. Patients endorsing high levels of distress on the PTSD Checklist (PCL-C) were randomized to enhanced usual care control or intervention conditions. Three hundred and fifty patients of the 635 randomized (55%) were from non-white and/or Hispanic backgrounds. The intervention included care management, cognitive behavioral therapy elements and, psychopharmacology addressing PTSD symptoms. The primary study outcome was PTSD symptoms assessed with the PCL-C at 3, 6, and 12 months postinjury. Mixed model regression analyses compared treatment effects for intervention and control group patients from non-white/Hispanic versus white/non-Hispanic backgrounds. Results: The investigation attained between 75% and 80% 3-month to 12-month follow-up. The intervention, on average, required 122 min (SD=132 min). Mixed model regression analyses revealed significant changes in PCL-C scores for non-white/Hispanic intervention patients at 6 months (adjusted difference -3.72 (95% CI -7.33 to -0.10) Effect Size =0.25, p<0.05) after the injury event. No significant differences were observed for white/non-Hispanic patients at the 6-month time point (adjusted difference -1.29 (95% CI -4.89 to 2.31) ES=0.10, p=ns). Conclusion: In this secondary analysis, a brief stepped collaborative care intervention was associated with greater 6-month reductions in PTSD symptoms for non-white/Hispanic patients when compared with white/non-Hispanic patients. If replicated, these findings could serve to inform future American College of Surgeon Committee on Trauma requirements for screening, intervention, and referral for PTSD and comorbidities. Level of evidence: Level II, secondary analysis of randomized clinical trial data reporting a significant difference. Trial registration number: NCT02655354.

A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study.

OBJECTIVE: Few investigations have comprehensively described methods for assessing and monitoring suicidal ideation in pragmatic clinical trials of mental health services interventions. This investigation's goal was to assess a collaborative care intervention's effectiveness in reducing suicidal ideation and describe suicide monitoring implementation in a nationwide protocol. METHOD: The investigation was a secondary analysis of a stepped wedge cluster randomized trial at 25-Level I trauma centers. Injury survivors (N = 635) were randomized to control (n = 370) and intervention (n = 265) conditions and assessed at baseline hospitalization and follow-up at 3-, 6- and 12-months post-injury. The Patient Health Questionnaire (PHQ-9) item-9 was used to evaluate patients for suicidal ideation. Mixed model regression was used to assess intervention versus control group changes in PHQ-9 item-9 scores over time and associations between baseline characteristics and development of suicidal ideation longitudinally. As part of the study implementation process assessment, suicide outreach call logs were also reviewed. RESULTS: Over 50% of patients endorsed suicidal ideation at ≥1 assessment. Intervention patients relative to control patients demonstrated reductions in endorsements of suicidal ideation that did not achieve statistical significance (F[3,1461] = 0.74, P = .53). The study team completed outreach phone calls, texts or voice messages to 268 patients with PHQ-9 item-9 scores ≥1 (n = 161 control, n = 107 intervention). CONCLUSIONS: Suicide assessment and monitoring can be feasibly implemented in large-scale pragmatic clinical trials. Intervention patients demonstrated less suicidal ideation over time; however, these comparisons did not achieve statistical significance. Intensive pragmatic trial monitoring may mask treatment effects by providing control patients a supportive intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354.

Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial.

Importance: To date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms. Objective: To simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity. Design, Setting, and Participants: A stepped-wedge cluster randomized clinical trial was conducted at 25 US level I trauma centers. Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms. Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N = 635) per the stepped-wedge protocol to enhanced usual care control (n = 370) or intervention (n = 265) conditions. The study was conducted from January 4, 2016, through November 2018. Data analysis was performed from November 4, 2019, to December 8, 2020. Interventions: The Trauma Survivors Outcomes and Support collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings. The intervention also integrated evidence-based pharmacotherapy and psychotherapeutic elements targeting PTSD symptoms and comorbidity. Main Outcomes and Measures: The primary study outcome was PTSD symptoms assessed with the PCL-C at baseline in the surgical ward and at 3, 6, and 12 months postinjury. Secondary outcomes included depressive symptoms, alcohol use, and physical function. Subgroup analyses examined the effect of baseline risk factors for enduring PTSD and quality of protocol implementation on study outcomes. Primary statistical analyses were conducted using the intent-to-treat sample. Results: A total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years. The investigation attained follow-up of 75% to 80% of the participants at 3 to 12 months. The intervention lasted a mean (SD) of 122 (132) minutes. Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35). Subgroup analyses revealed larger PTSD treatment effects for patients with 3 or more baseline risk factors for enduring PTSD and for patients, including firearm injury survivors, treated at trauma centers with good or excellent protocol implementation. Intervention effects for secondary outcomes did not attain statistical significance. Conclusions and Relevance: A brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions. Greater baseline PTSD risk and good or excellent trauma center protocol implementation were associated with larger PTSD treatment effects. Orchestrated efforts targeting policy and funding should systematically incorporate the study findings into national trauma center requirements and verification criteria. Trial Registration: ClinicalTrials.gov Identifier: NCT02655354.

Jail and Emergency Department Utilization in the Context of Harm Reduction Treatment for People Experiencing Homelessness and Alcohol Use Disorder.

People experiencing homelessness are disproportionately affected by alcohol use disorder (AUD). Abstinence-based treatment, however, does not optimally engage or treat this population. Thus, Harm Reduction Treatment for Alcohol (HaRT-A) was developed together with people with the lived experience of homelessness and AUD and community-based agencies that serve them. HaRT-A is a compassionate and pragmatic approach that aims to help people reduce alcohol-related harm and improve quality of life (QoL) without requiring abstinence or use reduction. The parent RCT showed that HaRT-A precipitated statistically significant reductions in alcohol use, alcohol-related harm, AUD symptoms, and positive urine toxicology tests. This secondary study tested HaRT-A effects on more distal, 6-month pre-to-posttreatment changes on jail and emergency department (ED) utilization. People experiencing homelessness and AUD (N = 168; 24% women) were recruited in community-based clinical and social services settings. Participants were randomized to receive HaRT-A or services as usual. Over four sessions, HaRT-A interventionists delivered three components: (a) collaborative tracking of participant-preferred alcohol metrics, (b) elicitation of harm-reduction and QoL goals, and (c) discussion of safer-drinking strategies. Administrative data on jail and ED utilization were extracted for 6 months pre- and posttreatment. Findings indicated no statistically significant treatment group differences on 6-month changes in jail or ED utilization (ps > .23). Exploratory analyses showed that 2-week frequency of alcohol use was positively correlated with number of jail bookings in the 12 months surrounding their study participation. Additionally, self-reported alcohol-related harm, importance of reducing alcohol-related harm, and perceived physical functioning predicted more ED visits. Future studies are needed to further assess how harm-reduction treatment may be enhanced to move the needle in criminal justice and healthcare utilization in the context of larger samples, longer follow-up timeframes, and more intensive interventions.

A Pragmatic Approach to Psychometric Comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in Acutely Injured Trauma Patients.

Objective: Prior investigations suggest the relative equivalence of the DSM-IV and DSM-5 versions of the Posttraumatic Stress Disorders (PTSD) Checklist, yet no investigations have assessed the psychometric properties of the scales in pragmatic trials of acutely injured trauma survivors. Method: DSM-IV and DSM-5 versions of the PTSD Checklist were included in follow-up interviews of physically injured patients enrolled longitudinally in a pragmatic clinical trial; pragmatic trials aim to efficiently implement research procedures to inform healthcare system policy changes. Psychometric comparisons of the DSM-IV, DSM-5, and a 20-item blended version of the scale included evaluations of internal consistency, correlational assessments, evaluation of item level agreements, and estimation of DSM-5 cutoffs that optimize electronic health record screening protocols. Results: 128 patients were included in the pragmatic psychometric study. Cronbach's alphas for the 3 versions of the PTSD Checklist ranged from 0.93 to 0.95. Correlations between the 3 scales ranged from 0.79 to 0.99. All 3 measures demonstrated excellent convergent and discriminant properties. Item level agreement ranged from 70-80%. For the DSM-5 and blended versions of the scale, a score of 30 and 24, respectively, best approximated the DSM-IV cutoff of ≥35 that had previously optimized PTSD detection in conjunction with EHR screening. Conclusions: Among injured trauma survivors, the psychometric performance of the DSM-IV PTSD Checklist with the addition of the 4 new DSM-5 PTSD Checklist items is nearly equivalent to the DSM-5 PTSD Checklist. The investigation also suggests that pragmatic psychometric methods can catalyze the rapid translation of research findings into real-world practice settings.

A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol.

Annually approximately 2-3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: (Clinicaltrials.govNCT03569878).