Acute and intensive care nurses' perspectives on suicide prevention with medically hospitalized patients: Exploring barriers, facilitators, interests, and training opportunities.

AIMS: To explore opportunities for acute and intensive care nurses to engage in suicide prevention activities with patients hospitalized for medical, surgical or traumatic injury reasons. DESIGN: A qualitative descriptive study. METHODS: We conducted two studies consisting of 1-h focus groups with nurses. Study 1 occurred prior to the onset of the COVID-19 pandemic during January and February of 2020 and identified barriers and facilitators of engaging in an eLearning training in suicide safety planning and engaging patients on their units in suicide safety planning. Study 2 occurred in December of 2020 and explored nurses' perspectives on their role in suicide prevention with patients on their units and training needs related to this. The research took place at an urban level 1 trauma center and safety net hospital where nurses universally screen all admitted patients for suicide risk. We conducted a rapid analysis of the focus group transcripts using a top-down, framework-driven approach to identify barriers, facilitators, strategies around barriers, and training interests mentioned. RESULTS: Twenty-seven registered nurses participated. Nurses indicated they serve a population in need of suicide prevention and that the nursing role is an important part of suicide care. A primary barrier was having adequate uninterrupted time for suicide prevention activities and training; however, nurses identified various strategies around barriers and offered suggestions to make training successful. CONCLUSION: Findings suggest training in suicide prevention is important for nurses in this context and there are opportunities for nurses to engage patients in interventions beyond initial screening; however, implementation will require tailoring interventions and training to accommodate nurses' workload in the hospital context. IMPACT: Acute and intensive care nurses play a key role in the public health approach to suicide prevention. Understanding perspectives of bedside nurses is critical for guiding development and deployment of effective brief interventions. NO PUBLIC OR PATIENT INVOLVEMENT: This study is focused on eliciting and exploring perspectives of acute and intensive care nurses.

Understanding Psychological Distress and Protective Factors Amongst Older Adults During the COVID-19 Pandemic.

OBJECTIVES: This study examined the emotional distress and loneliness during COVID-19 and the roles of resiliency and activities. DESIGN: A cross-sectional national survey. SETTING: Amazon Mechanical Turk (mTurk) and Prolific Research Platforms. PARTICIPANTS: Five hundred and one U.S. dwelling English-speaking adults 60 years old and older. MEASUREMENTS: Participants completed an online survey with the PHQ-9; GAD-7; Short Health Anxiety Inventory; 3-item UCLA Loneliness scale; PROMIS measures of global health, instrumental, and emotional support; 10-item Connor-Davidson Resilience Scale; and COVID-19 needs assessment. RESULTS: Across the sample 13% reported moderate depressive symptoms, 9% reported moderate anxiety symptoms, and 26% endorsed being "lonely." The emotionally distressed group endorsed more loneliness, lower resiliency, less physical exercise, and worse physical health. The low Socio-Economic Status group endorsed less loneliness, less likely to engage in physical exercise and worse physical health.The lonely group endorsed less resilience, less physical exercise, and worse physical health. A multiple logistic regression found that resilience, socioeconomic status, and physical health were significant predictors of loneliness, whereas global health was the best predictor of emotional distress. CONCLUSIONS: Even after prolonged social distancing, older adults in this study did not report greater psychological distress compared to earlier studies of older adults during COVID-19. Older adults with lower SES, worse physical health, and less resiliency, were more likely to report more loneliness. It is this group that should be the focus of intervention.

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.

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.

Resilience in community: a social ecological development model for young adult sexual minority women.

Family support and rejection are associated with health outcomes among sexual minority women (SMW). We examined a social ecological development model among young adult SMW, testing whether identity risk factors or outness to family interacted with family rejection to predict community connectedness and collective self-esteem. Lesbian and bisexual women (N = 843; 57% bisexual) between the ages of 18-25 (M = 21.4; SD = 2.1) completed baseline and 12-month online surveys. The sample identified as White (54.2%), multiple racial backgrounds (16.6%), African American (9.6%) and Asian/Asian American (3.1%); 10.2% endorsed a Hispanic/Latina ethnicity. Rejection ranged from 18 to 41% across family relationships. Longitudinal regression indicated that when outness to family increased, SMW in highly rejecting families demonstrated resilience by finding connections and esteem in sexual minority communities to a greater extent than did non-rejected peers. But, when stigma concerns, concealment motivation, and other identity risk factors increased over the year, high family rejection did not impact community connectedness and SMW reported lower collective self-esteem. Racial minority SMW reported lower community connectedness, but not lower collective self-esteem. Families likely buffer or exacerbate societal risks for ill health. Findings highlight the protective role of LGBTQ communities and normative resilience among SMW and their families.

Caregiver-youth communication about sex in South Africa: the role of maternal child sexual abuse history.

Much of the research on child sexual abuse focuses on negative outcomes. This brief report explores a potentially protective parenting behavior among black South African female caregivers with and without a child sexual abuse history. Using cross-sectional baseline data, we hypothesized that caregiver child sexual abuse history would be positively associated with caregiver-youth sex communication and this relationship would be strongest for girls. Youth whose caregiver experienced child sexual abuse were more likely to report communicating with their caregiver about sex than youth whose caregivers did not experience child sexual abuse; however, this relation did not hold for caregiver reported communication. Child sexual abuse survivors' ability and decision to discuss sex with their youth has the potential to protect youth from sexual risk and demonstrates resilience among a group rarely acknowledged for positive parenting practices.

Harnessing Innovative Technologies to Train Nurses in Suicide Safety Planning With Hospital Patients: Formative Acceptability Evaluation of an eLearning Continuing Education Training.

BACKGROUND: Suicide is the 12th leading cause of death in the United States. Health care provider training is a top research priority identified by the National Action Alliance for Suicide Prevention; however, evidence-based approaches that target skill building are resource intensive and difficult to implement. Novel computer technologies harnessing artificial intelligence are now available, which hold promise for increasing the feasibility of providing trainees opportunities across a range of continuing education contexts to engage in skills practice with constructive feedback on performance. OBJECTIVE: This pilot study aims to evaluate the feasibility and acceptability of an eLearning training in suicide safety planning among nurses serving patients admitted to a US level 1 trauma center for acute or intensive care. The training included a didactic portion with demonstration, practice of microcounseling skills with a web-based virtual patient (Client Bot Emily), role-play with a patient actor, and automated coding and feedback on general counseling skills based on the role-play via a web-based platform (Lyssn Advisor). Secondarily, we examined learning outcomes of knowledge, confidence, and skills in suicide safety planning descriptively. METHODS: Acute and intensive care nurses were recruited between November 1, 2021, and May 31, 2022, to participate in a formative evaluation using pretraining, posttraining, and 6-month follow-up surveys, as well as observation of the nurses' performance in delivering suicide safety planning via standardized patient role-plays over 6 months and rated using the Safety Plan Intervention Rating Scale. Nurses completed the System Usability Scale after interacting with Client Bot Emily and reviewing general counseling scores based on their role-play via Lyssn Advisor. RESULTS: A total of 18 nurses participated in the study; the majority identified as female (n=17, 94%) and White (n=13, 72%). Of the 17 nurses who started the training, 82% (n=14) completed it. On average, the System Usability Scale score for Client Bot Emily was 70.3 (SD 19.7) and for Lyssn Advisor was 65.4 (SD 16.3). On average, nurses endorsed a good bit of knowledge (mean 3.1, SD 0.5) and confidence (mean 2.9, SD 0.5) after the training. After completing the training, none of the nurses scored above the expert-derived cutoff for proficiency on the Safety Plan Intervention Rating Scale (≥14); however, on average, nurses were above the cutoffs for general counseling skills per Lyssn Advisor (empathy: mean 4.1, SD 0.6; collaboration: mean 3.6, SD 0.7). CONCLUSIONS: Findings suggest the completion of the training activities and use of novel technologies within this context are feasible. Technologic modifications may enhance the training acceptability and utility, such as increasing the virtual patient conversational abilities and adding automated coding capability for specific suicide safety planning skills. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33695.

Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial.

BACKGROUND: Depression, anxiety, post-traumatic stress, and alcohol/substance use disorders are prevalent among people with HIV (PWH), commonly co-occur, and predict worse HIV care outcomes. Transdiagnostic counseling approaches simultaneously address multiple co-occurring mental health disorders. METHODS: We conducted a pilot individually randomized trial of the Common Elements Treatment Approach adapted for people with HIV (CETA-PWH), a transdiagnostic counseling intervention, compared with usual care at a large academic medical center in the southern United States. Participants were adults with HIV; at risk for HIV care disengagement; and with elevated symptoms of depression, anxiety, post-traumatic stress, and/or alcohol/substance use. Mental health and HIV care engagement were assessed at 4 and 9 months. RESULTS: Among participants (n = 60), follow-up was high at 4 (92%) and 9 (85%) months. Intervention engagement was challenging: 93% attended ≥1 session, 43% attended ≥6 sessions in 3 months ("moderate dose"), and 30% completed treatment. Although not powered for effectiveness, mental health outcomes and HIV appointment attendance improved in CETA-PWH relative to usual care in intent-to-treat analyses; those receiving a moderate dose and completers showed progressively greater improvement. Viral load showed small differences between arms. The dose-response pattern was not explained by differences between those who did and did not complete treatment. CONCLUSIONS: This pilot trial provides preliminary evidence for the potential of CETA-PWH to simultaneously address co-occurring mental health comorbidities and support HIV appointment attendance among PWH. Additional strategies may be an important part of ensuring that clients can engage in the full course of treatment and realize its full benefits.

Understanding the impact of the COVID-19 pandemic on U.S. older adults: self-reported pandemic-related concerns and consequences in a cross-sectional survey study.

Background and objectives: The purpose of this study was to explore COVID-19 pandemic-related concerns among a racially and ethnically representative sample of older adults in the U.S. Research design and methods: Participants were 501 English-speaking adults 60 years and older recruited online nationally across the U.S. from Amazon Mechanical Turk (mTurk) and Prolific Research Platforms during June of 2020. Data comes from a larger cross-sectional survey. We content analyzed open-ended responses about pandemic-related concerns and observed responses to a checklist of items created by the research team to assess for specific physical, social, and financial consequences experienced due to the pandemic. Results: A majority of the sample (92%) reported at least one pandemic-related concern, with the highest percentage expressing concerns coded as Concern for Others (28%), Physical Health (27%), Socializing (24%), Finance (15%) and Socio-Political-Economic (14%). Participants reported high concern severity (M = 4.03, SD = 1.04) about their concerns mentioned in response to the open-ended concerns question. When prompted with a checklist of items, participants frequently endorsed disruption in social activities as a consequence of the pandemic (83%), disruptions that could impact physical health (45%), and concern over finances as a consequence of the pandemic (41%). Discussion and implications: Older adults most frequently mentioned concerns about the well-being and behavior of others, one's own physical health, and the impacts of the pandemic and social distancing policies on social activities. Findings align with the Socioemotional Selectivity Theory and point to the importance of supporting older adults to maintain meaningful social engagement under conditions of a pandemic and social distancing policies.

Using Principles of an Adaptation Framework to Adapt a Transdiagnostic Psychotherapy for People With HIV to Improve Mental Health and HIV Treatment Engagement: Focus Groups and Formative Research Study.

BACKGROUND: HIV treatment engagement is critical for people with HIV; however, behavioral health comorbidities and HIV-related stigma are key barriers to engagement. Treatments that address these barriers and can be readily implemented in HIV care settings are needed. OBJECTIVE: We presented the process for adapting transdiagnostic cognitive behavioral psychotherapy, the Common Elements Treatment Approach (CETA), for people with HIV receiving HIV treatment at a Southern US HIV clinic. Behavioral health targets included posttraumatic stress, depression, anxiety, substance use, and safety concerns (eg, suicidality). The adaptation also included ways to address HIV-related stigma and a component based on Life-Steps, a brief cognitive behavioral intervention to support patient HIV treatment engagement. METHODS: We applied principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing model, a framework for adapting evidence-based HIV interventions, and described our adaptation process, which included adapting the CETA manual based on expert input; conducting 3 focus groups, one with clinic social workers (n=3) and 2 with male (n=3) and female (n=4) patients to obtain stakeholder input for the adapted therapy; revising the manual according to this input; and training 2 counselors on the adapted protocol, including a workshop held over the internet followed by implementing the therapy with 3 clinic patients and receiving case-based consultation for them. For the focus groups, all clinic social workers were invited to participate, and patients were referred by clinic social workers if they were adults receiving services at the clinic and willing to provide written informed consent. Social worker focus group questions elicited reactions to the adapted therapy manual and content. Patient focus group questions elicited experiences with behavioral health conditions and HIV-related stigma and their impacts on HIV treatment engagement. Transcripts were reviewed by 3 team members to catalog participant commentary according to themes relevant to adapting CETA for people with HIV. Coauthors independently identified themes and met to discuss and reach a consensus on them. RESULTS: We successfully used principles of the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, Testing framework to adapt CETA for people with HIV. The focus group with social workers indicated that the adapted therapy made conceptual sense and addressed common behavioral health concerns and practical and cognitive behavioral barriers to HIV treatment engagement. Key considerations for CETA for people with HIV obtained from social worker and patient focus groups were related to stigma, socioeconomic stress, and instability experienced by the clinic population and some patients' substance use, which can thwart the stability needed to engage in care. CONCLUSIONS: The resulting brief, manualized therapy is designed to help patients build skills that promote HIV treatment engagement and reduce symptoms of common behavioral health conditions that are known to thwart HIV treatment engagement.

Predictors of Disengagement and Symptom Improvement Among Adults With Depression Enrolled in Talkspace, a Technology-Mediated Psychotherapy Platform: Naturalistic Observational Study.

BACKGROUND: Depression is a common psychiatric condition with an estimated lifetime prevalence for major depression of 16.6% in the US adult population and is effectively treated through psychotherapy. The widespread availability of the internet and personal devices such as smartphones are changing the landscape of delivery of psychotherapy; however, little is known about whether and for whom this type of therapy is beneficial, and whether having synchronous video-based sessions provides additional benefits to clients above and beyond messaging-based therapy. OBJECTIVE: This study examined the outcomes associated with the use of a digital platform (Talkspace) for technology-mediated psychotherapy. We examined the duration of client engagement in therapy and client depression score trajectories over 16 weeks. We explored the association of client characteristics, therapist characteristics, and service plan type with time-to-disengagement and trajectories of change in depression scores. METHODS: This naturalistic observational study assessed data collected routinely by the platform between January 2016 and January 2018 and examined psychotherapy outcomes among a large representative sample of adult clients with clinically significant depression. Treatment disengagement was defined as a lack of client-initiated communication for more than 4 weeks. Clients completed the Patient Health Questionnaire-8 item (PHQ-8) at intake and every 3 weeks via an in-app survey. Cox regression analysis was used to examine the time until and predictors of disengagement. Changes in depression scores and predictors of change over time were examined using mixed-effects regression. RESULTS: The study included 5890 clients and 1271 therapists. Client scores on the PHQ-8 declined over time, with the average client improving from a score of 15 to below the clinical cutoff of 10 by week 6. At the same time point, 37% of clients had disengaged from the therapy. When combined into a final Cox regression model, those who were more likely to disengage were clients aged 18 to 25 years versus those aged ≥50 years (odds ratio [OR] 0.82, 95% CI 0.74-0.9; P<.001), had higher education (OR 1.14, 95% CI 1.06-1.22; P<.001), had been in therapy before (OR 1.09, 95% CI 1.02-1.17; P=.01), and were living with a partner but unmarried versus single (OR 1.14, 95% CI 1.02-1.27; P=.02). Having a therapist with >10 years of experience was related to lower odds of disengagement (OR 0.87, 95% CI 0.8-0.94; P=.01). When combined into a final regression model predicting improvement in depression scores over time, clients showing more improvement were those with an associate's degree or higher (linear estimate=-0.07, P=.002) and higher intake PHQ-8 scores (estimate=3.73, P<.001). There were no differences based on the plan type. CONCLUSIONS: Our findings add to the growing literature showing the benefits of technology-mediated psychotherapy over a relatively brief period (16 weeks).

Harnessing Innovative Technologies to Train Nurses in Suicide Safety Planning With Hospitalized Patients: Protocol for Formative and Pilot Feasibility Research.

BACKGROUND: Suicide is the 10th leading cause of death in the United States, with >47,000 deaths in 2019. Most people who died by suicide had contact with the health care system in the year before their death. Health care provider training is a top research priority identified by the National Action Alliance for Suicide Prevention; however, evidence-based approaches that target skill-building are resource intensive and difficult to implement. Advances in artificial intelligence technology hold promise for improving the scalability and sustainability of training methods, as it is now possible for computers to assess the intervention delivery skills of trainees and provide feedback to guide skill improvements. Much remains to be known about how best to integrate these novel technologies into continuing education for health care providers. OBJECTIVE: In Project WISE (Workplace Integrated Support and Education), we aim to develop e-learning training in suicide safety planning, enhanced with novel skill-building technologies that can be integrated into the routine workflow of nurses serving patients hospitalized for medical or surgical reasons or traumatic injury. The research aims include identifying strategies for the implementation and workflow integration of both the training and safety planning with patients, adapting 2 existing technologies to enhance general counseling skills for use in suicide safety planning (a conversational agent and an artificial intelligence-based feedback system), observing training acceptability and nurse engagement with the training components, and assessing the feasibility of recruitment, retention, and collection of longitudinal self-report and electronic health record data for patients identified as at risk of suicide. METHODS: Our developmental research includes qualitative and observational methods to explore the implementation context and technology usability, formative evaluation of the training paradigm, and pilot research to assess the feasibility of conducting a future cluster randomized pragmatic trial. The trial will examine whether patients hospitalized for medical or surgical reasons or traumatic injury who are at risk of suicide have better suicide-related postdischarge outcomes when admitted to a unit with nurses trained using the skill-building technology than those admitted to a unit with untrained nurses. The research takes place at a level 1 trauma center, which is also a safety-net hospital and academic medical center. RESULTS: Project WISE was funded in July 2019. As of September 2021, we have completed focus groups and usability testing with 27 acute care and 3 acute and intensive care nurses. We began data collection for research aims 3 and 4 in November 2021. All research has been approved by the University of Washington institutional review board. CONCLUSIONS: Project WISE aims to further the national agenda to improve suicide prevention in health care settings by training nurses in suicide prevention with medically hospitalized patients using novel e-learning technologies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33695.

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.

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.

Adolescent clinical populations and associations between trauma and behavioral and emotional problems.

OBJECTIVE: Trauma exposure is common during childhood and adolescence and is associated with youth emotional and behavioral problems. The present study adds to the current literature on trauma exposure among adolescent clinical populations by examining the association between trauma exposure and adolescent self-report of emotional and behavioral problems broadly, including internalizing and externalizing symptoms, in addition to the trauma-specific symptoms of posttraumatic stress disorder (PTSD). METHOD: This study included 94 female (64%) and male (36%) adolescents, ages 13-19, representing 4 clinical populations: those seeking inpatient psychiatry, outpatient psychiatry, residential substance abuse, and outpatient medical services. Adolescents self-reported trauma history and internalizing, externalizing, and PTSD symptoms. RESULTS: Most adolescents reported experiencing at least 1 traumatic event (83%; M = 2.28, SD = 1.83). Multiple regression analyses controlling for age, race/ethnicity, gender, and treatment setting indicated a greater number of types of trauma are associated with externalizing symptoms (ß = .31, p < .01) and PTSD symptoms (ß = .35, p < .01). CONCLUSION: Trauma is a common experience among adolescents, particularly those presenting for behavioral health services, making trauma-informed care essential in these service delivery settings. Treatment that addresses adolescent risk behaviors and prevents recurrent trauma may be particularly important given the negative impact of multiple traumatic events on developing adolescents. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Implementing Transdiagnostic Cognitive Behavioral Psychotherapy in Adult Public Behavioral Health: A Pilot Evaluation of the Feasibility of the Common Elements Treatment Approach (CETA).

Few evidence-based psychotherapies are provided in adult public behavioral health (PBH), despite the need for such treatments. The common elements treatment approach (CETA) was developed for use by lay providers in low- and middle-income countries and may have relevance in PBH given its unique application with individuals with multiple diagnoses including PTSD, depression, and anxiety. This study utilized data collected as part of the implementation of CETA in 9 PBH agencies in Washington State with 58 providers, including a 2-day workshop and 6 months of consultation. Outcomes included provider-perceived skill in CETA delivery, training and consultation completion rates, and perceived appropriateness of CETA for clients. Thirty-nine (67%) providers completed requirements for training and consultation, and delivered CETA to a total of 56 clients. Perceived competence in delivering CETA improved over time, as well as client symptom scores. CETA shows promise for feasible and effective implementation within US-based PBH systems.

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.

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.