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.

Nationwide Survey of Trauma Center Screening and Intervention Practices for Posttraumatic Stress Disorder, Firearm Violence, Mental Health, and Substance Use Disorders.

BACKGROUND: Posttraumatic stress disorder (PTSD) symptoms, firearm violence events, alcohol and drug use problems, and major depression and suicidal ideation are endemic among patients admitted to US trauma centers. Despite increasing policy importance, the current availability of screening and intervention services for this constellation of conditions in US trauma centers is unknown. STUDY DESIGN: Trauma program staff at all Level I and Level II trauma centers in the US. (N = 627) were contacted to complete a survey describing screening and intervention procedures for alcohol and drug use problems, PTSD symptoms, depression and suicidality, and firearm violence. Additional questions asked trauma centers about the delivery of peer interventions and information technology capacity for screening and intervention procedures. RESULTS: Fifty-one percent of trauma centers (n = 322) responded to the survey. More than 95% of responding sites endorsed routinely screening and/or intervening for alcohol use problems. Routine services addressing PTSD were less common, with 28% of centers reporting routine screening. More than 50% of sites that screened for PTSD used previously established trauma center alcohol use services. Programmatic screening and intervention for firearm injury sequelae was occurring at 30% of sites. CONCLUSION: Alcohol screening and intervention is occurring frequently at US trauma centers and appears to be responsive to American College of Surgeons Committee on Trauma verification requirements. Routine screening and intervention services for PTSD and firearm injury were occurring less frequently. Regular national surveys may be a key element of tracking progress in national mental health and substance use screening, intervention, and referral policy.

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.

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Pragmatic Quality Assessment of Brief Health Behavior Change Interventions: Evidence for Criterion-Related Validity of the Behavior Change Counseling Index.

BACKGROUND: Healthcare providers frequently engage patients in conversations about health behavior change and are encouraged to use patient-centered approaches, such as Motivational Interviewing. Training in and sustainment of these skills are known to require feedback based on actual or role-played patient encounters. The behavior change counseling index (BECCI) is a pragmatic measure to assess healthcare providers' patient-centered behavior change counseling skills that was developed as an alternative to resource-intensive "gold standard" measures, which are difficult to use in routine practice. We are not aware of any studies that examine the criterion-related validity of this measure using an alternative gold standard measure. We examined the criterion-related validity of the BECCI as rated by a simulated patient actor immediately after a brief behavior change intervention role-play using objective ratings on the motivational interviewing treatment integrity (MITI) scale. METHODS: We conducted a secondary analysis of data from a 25-site clinical trial of screening and intervention for posttraumatic stress disorder and comorbidities with patients at level I trauma centers in the USA. Participants were 64 providers representing diverse professional roles trained to deliver a multi-component intervention with study patients. As part of the training, providers role-played counseling a patient to reduce risky alcohol use with a simulated patient actor. These 20-min role-plays were conducted by telephone and audio recorded. Immediately after the role-play, the simulated patient actor rated the quality of the providers' patient-centered behavior change counseling skills using the BECCI. A third-party expert MITI rater later listened to the audio recordings of the role-plays and rated the quality of the providers' patient-centered behavior change counseling skills using the MITI 3.1.1. RESULTS: All correlations observed were statistically significant. The overall BECCI score correlated strongly (≥ 0.50) with five of the six MITI scores and moderately (0.33) with MITI percent complex reflections. CONCLUSIONS: This study provides evidence of criterion-related validity of the BECCI with a sample of healthcare providers representing a range of professional roles. Simulated patient actor rating using the BECCI is a pragmatic approach to assessing the quality of brief behavior change interventions delivered by healthcare providers.

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.

Task-shifting to improve the reach of mental health interventions for trauma patients: findings from a pilot study of trauma nurse training in patient-centered activity scheduling for PTSD and depression.

Despite high rates of posttraumatic stress disorder (PTSD) and depression among traumatically injured patients, engagement in session-based psychotherapy early after trauma is limited due to various service utilization and readiness barriers. Task-shifting brief mental health interventions to routine trauma center providers is an understudied but potentially critical part of the continuum of care. This pilot study assessed the feasibility of training trauma nurses to engage patients in patient-centered activity scheduling based on a Behavioral Activation paradigm, which is designed to counteract dysfunctional avoidance/withdrawal behavior common among patients after injury. Nurses (N = 4) and patients (N = 40) were recruited from two level II trauma centers. A portion of a one day in-person workshop included didactics, demonstrations, and experiential activities to teach brief intervention delivery. Nurses completed pre- and posttraining standardized patient role-plays prior to and two months after training, which were coded for adherence to the intervention. Nurses also completed exit interviews to assess their perspectives on the training and addressing patient mental health concerns. Findings support the feasibility of training trauma nurses in a brief mental health intervention. Task-shifting brief interventions holds promise for reaching more of the population in need of posttrauma mental health care.

Evaluation of a Level I trauma center provider training in patient-centered alcohol brief interventions using the Behavior Change Counseling Index rated by standardized patients.

BACKGROUND: Traumatic injury requiring hospitalization is common in the USA and frequently related to alcohol consumption. The American College of Surgeons requires that Level I and II verified trauma centers implement universal alcohol screening and brief intervention for injured patients. We examined whether Level I trauma center provider skill in patient-centered alcohol brief interventions improved after training and whether professional role (eg, nursing, social work) and education were associated with these skills. METHODS: We present evaluation data collected as part of training in alcohol brief interventions embedded within a larger clinical trial of a collaborative care intervention targeting posttraumatic stress disorder and related comorbidities. Sixty-five providers from 25 US Level I trauma centers engaged in a 1-day workshop, with 2 hours dedicated to training in patient-centered alcohol brief interventions followed by 6 months of weekly coaching in a collaborative care model. Providers completed standardized patient role-plays prior to and 6 months after the workshop training. The standardized patient actors rated provider quality of alcohol brief interventions immediately after each role-play using the Behavior Change Counseling Index (BECCI), a pragmatic measure designed to assess the quality of behavior change counseling, an adaptation of motivational interviewing suitable for brief healthcare consultations about behavior change. RESULTS: Seventy-two percent of providers completed both standardized patient role-play assessments. A statistically significant improvement in overall BECCI scores (t(41)=-2.53, p=0.02, Cohen's d=-0.39) was observed among those providers with available pre-post data. Provider professional role was associated with BECCI scores at pre-training (F(3, 58)=11.25, p<0.01) and post-training (F(3, 41)=8.10, p<0.01). DISCUSSION: Findings underscore the need for training in patient-centered alcohol brief interventions and suggest that even a modest training helps providers engage in a more patient-centered way during a role-play assessment. LEVEL OF EVIDENCE: Level V, therapeutic/care management.

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.

Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder.

OBJECTIVE: This investigation comprehensively assessed the technology use, preferences, and capacity of diverse injured trauma survivors with posttraumatic stress disorder (PTSD) symptoms. METHOD: A total of 121 patients participating in a randomized clinical trial (RCT) of stepped collaborative care targeting PTSD symptoms were administered baseline one-, three-, and six-month interviews that assessed technology use. Longitudinal data about the instability of patient cell phone ownership and phone numbers were collected from follow-up interviews. PTSD symptoms were also assessed over the course of the six months after injury. Regression analyses explored the associations between cell phone instability and PTSD symptoms. RESULTS: At baseline, 71.9% (n = 87) of patients reported current cell phone ownership, and over half (58.2%, n = 46) of these patients possessed basic cell phones. Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury. In regression models that adjusted for relevant clinical and demographic characteristics, cell phone instability was associated with higher six-month postinjury PTSD symptom levels (p < 0.001). CONCLUSIONS: Diverse injured patients at risk for the development of PTSD have unique technology use patterns, including high rates of cell phone instability. These observations should be strongly considered when developing technology-supported interventions for injured patients with PTSD.