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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.

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; PPP=.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 CONCLUSIONS Our findings add to the growing literature showing the benefits of technology-mediated psychotherapy over a relatively brief period (16 weeks).

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 DERR1-10.2196/33695

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. J Clin Med Res. 2019;11(11):764-768 doi: https://doi.org/10.14740/jocmr4018

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.

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; P10 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 Conclusions Our findings add to the growing literature showing the benefits of technology-mediated psychotherapy over a relatively brief period (16 weeks).

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 post-training 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 post-trauma mental health care.

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.

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

Background The recent growth in organized efforts to advance dissemination and implementation (D & I) science suggests a rapidly expanding community focused on the adoption and sustainment of evidence-based practices (EBPs). Although promising for the D & I of EBPs, the proliferation of initiatives is difficult for any one individual to navigate and summarize. Such proliferation may also result in redundant efforts or missed opportunities for participation and advancement. A review of existing D & I science resource initiatives and their unique merits would be a significant step for the field. The present study aimed to describe the global landscape of these organized efforts to advance D & I science. Methods We conducted a content analysis between October 2015 and March 2016 to examine resources and characteristics of D & I science resource initiatives using public, web-based information. Included resource initiatives must have engaged in multiple efforts to advance D & I science beyond conferences, offered D & I science resources, and provided content in English. The sampling method included an Internet search using D & I terms and inquiry among internationally representative D & I science experts. Using a coding scheme based on a priori and grounded approaches, two authors consensus coded website information including interactive and non-interactive resources and information regarding accessibility (membership, cost, competitive application, and location). Results The vast majority (83%) of resource initiatives offered at least one of seven interactive resources (consultation/technical assistance, mentorship, workshops, workgroups, networking, conferences, and social media) and one of six non-interactive resources (resource library, news and updates from the field, archived talks or slides, links pages, grant writing resources, and funding opportunities). Non-interactive resources were most common, with some appearing frequently across resource initiatives (e.g., news and updates from the field). Conclusion Findings generated by this study offer insight into what types of D & I science resources exist and what new resources may have the greatest potential to make a unique and needed contribution to the field. Additional interactive resources may benefit the field, particularly mentorship opportunities and resources that can be accessed virtually. Moving forward, it may be useful to consider strategic attention to the core tenets of D & I science put forth by Glasgow and colleagues to most efficiently and effectively advance the field.

Collaborative Care is a comprehensive longitudinal care management strategy. The purpose of this pilot effectiveness-implementation hybrid study was to determine the feasibility of a Collaborative Care intervention initiated from the Emergency Department and proceeding longitudinally for six months for injured patients with prescription drug misuse (PDM). Adult patients presenting to an urban ED with an injury were screened for eligibility from 2/2015-8/2015. Eligible participants with a positive screen for PDM were enrolled in the ‘ED-LINC’ intervention which included the following elements: 1) active care coordination and linkage, 2) medication safety and utilization of opioid guidelines 3) longitudinal care management and 4) utilization of Electronic Medical Record (EMR) innovations such as the statewide Emergency Department Information Exchange (EDIE) and statewide prescription monitoring program information for assessment and follow-up. Baseline characteristics of the sample were assessed and regression models were used to evaluate longitudinal trajectories of risk for PDM. A total of 36 participants (56% of patients approached) had PDM and 30 participants were enrolled. Of those enrolled, 37% had prescription stimulant misuse, 20% with prescription sedative misuse and 97% had prescription opioid misuse. Follow-up rates at all time points were ≥ 83%. Baseline levels of comorbidity were high; 57% endorsed recent heroin use and 70% endorsed symptoms consistent with major depression. Over 50% had five or more statewide ED visits and 53% had used three or more different ED‘s in the past year. On average, participants received a total of 85 minutes of ED-LINC over six months with 90% of participants receiving all four intervention elements. All patients had care coordinated with new or existing primary care providers (PCP’s) and 23% were linked to a new PCP. A majority of patients (≥ 80%) reported receiving high quality, desired intervention services. There was no significant change in PDM over time. Collaborative Care initiated from the ED is feasible and acceptable to patients with trauma and PDM. Future directions could include effectiveness-implementation hybrid trials to study implementation barriers and strategies as well as patient-level outcomes of this intervention for this complex patient population.

ImportanceTo date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms.ObjectiveTo simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity.Design, Setting, and ParticipantsA 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 2019. Data analysis was performed from November 4, 2019, to December 8, 2020.InterventionsThe 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 MeasuresThe 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.ResultsA 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 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 RelevanceA 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 RegistrationClinicalTrials.gov Identifier: NCT02655354

The American College of Surgeons requires Level I and II trauma centers to provide brief intervention services to traumatically injured patients who screen positive for alcohol. Despite evidence supporting substantial cost savings and reduced re-injury associated with these services, brief interventions may not be uniformly delivered owing to a variety of demographic, clinical and operational characteristics. To inform service adjustments that may improve the reach of such services, we compared trauma patients who did and did not receive brief alcohol intervention services during their hospitalizations. Electronic medical records of injured patients admitted to a Level I trauma center between September 27, 2013 and March 11, 2014 with a positive blood alcohol concentration (N = 189) were coded for demographic and clinical variables. Records of those who did not receive a brief intervention during their admission were reviewed for possible reasons why interventions were not delivered. Of the total sample, 115 patients (60.8%) received brief interventions. Patients who did and did not receive brief interventions did not differ on age, sex, race, blood alcohol concentration at admission, or mechanism of injury, indicating that patient characteristics were unlikely to bias service delivery. Instead, common features of patients who were referred but did not receive SBIRT interventions included admissions lasting fewer than two working days (12.7%) and persistent cognitive impairment following injury (9.0%). These findings align with previous studies suggesting that service reach could be improved by promoting dedicated and flexible staffing and adapting services to allow for SBIRT delivery in follow-up care settings.

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, assau...

The aim of this randomized comparative effectiveness trial was to compare 2 approaches to the delivery of patient‐centered care for hospitalized injured trauma survivors: a novel patient‐centered care transition service delivery model versus enhanced usual care that included notifications to nurses of trauma survivors’ postinjury concerns.

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.

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 (β = .31, p < .01) and PTSD symptoms (β = .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).

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.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.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.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.

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.

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.

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.

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.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.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.Integrating behavioral interventions into routine acute care service delivery may improve the reach of evidence-based mental health care targeting PTSD.

Introduction to the 3rd Biennial Conference of the Society for Implementation Research Collaboration: advancing efficient methodologies through team science and community partnerships

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. 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. 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. ClinicalTrials.gov NCT02655354 . Registered 27 July 2015.