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A rapid ethnographic assessment of delivery of mental health services to patients at a Level I trauma center in a major metropolitan hospital undergoing a COVID-19 surge was conducted to assess the challenges involved in services delivery and to compare the experience of delivering services across time. Study participants were patients and providers who interacted with or otherwise were observed by three clinicians engaged in the delivery of care within the Emergency Department (ED) and Trauma Center at Harborview Medical Center from the COVID-19-related "surge" in April to the end of July 2020. Data were collected and analyzed in accordance with the Rapid Assessment Procedures-Informed Clinical Ethnography (RAPICE) protocol. Community and institutional efforts to control the spread of the coronavirus created several challenges to providing mental health services in an acute care setting during the April surge. Most of these challenges were successfully addressed by standardization of infection control protocols, but new challenges emerged including an increase in expenses for infection control and reduction in clinical revenues due to fewer patients, furloughs of mental health services providers and peer specialists in the ED, services not provided or delayed, increased stress due to fear of furloughs or increased workload of those not furloughed, and increases in patients seen with injuries due to risky behavior, violence, and substance use. These findings illustrate the rapidly shifting nature of the pandemic, its impacts on mental health services, and the mitigation efforts of communities and healthcare systems.

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

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=0.53). 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

Background The expedient translation of research findings into sustainable intervention procedures is a longstanding health care system priority. The Patient-Centered Outcomes Research Institute (PCORI) has facilitated the development of "research done differently," with a central tenet that key stakeholders can be productively engaged throughout the research process. Literature review revealed few examples of whether, as originally posited, PCORI's innovative stakeholder-driven approach could catalyze the expedient translation of research results into practice. Objectives This narrative review traces the historical development of an American College of Surgeons Committee on Trauma (ACS/COT) policy guidance, facilitated by evidence supplied by the PCORI-funded studies evaluating the delivery of patient-centered care transitions. Key elements catalyzing the guidance are reviewed, including the sustained engagement of ACS/COT policy stakeholders who have the capacity to invoke system-level implementation strategies, such as regulatory mandates linked to verification site visits. Other key elements, including the encouragement of patient stakeholder voice in policy decisions and the incorporation of end-of-study policy summits in pragmatic comparative effectiveness trial design, are discussed. Conclusions Informed by comparative effectiveness trials, ACS/COT policy has expedited introduction of the patient-centered care construct into US trauma care systems. A comparative health care systems conceptual framework for transitional care which incorporates Research Lifecycle, pragmatic clinical trial and implementation science models is articulated. When combined with Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE), employed as a targeted implementation strategy, this approach may accelerate the sustainable delivery of high-quality patient-centered care transitions for US trauma care systems.

OBJECTIVE To describe the demographic, injury-related, and mental health characteristics of firearm injury patients and trace firearm weapon carriage and PTSD symptoms over the year after injury. SUMMARY AND BACKGROUND DATA Based on the increasing incidence of firearm injury and need for novel injury prevention strategies, hospital-based violence intervention programs are being implemented in US trauma centers. There is limited data on the long-term outcomes and risk behaviors of firearm injury survivors to guide this work. METHODS We conducted a secondary analysis of a pragmatic 25-trauma center randomized trial (N = 635). Baseline characteristics of firearm-injured patients (N = 128) were compared with other trauma patients. Mixed model regression was used to identify risk factors for postinjury firearm weapon carriage and PTSD symptoms. RESULTS Firearm injury patients were younger and more likely to be black, male and of lower socioeconomic status, and more likely to carry a firearm in the year before injury. Relative to preinjury, there was a significant drop in firearm weapon carriage at 3- and 6-months postinjury, followed by a return to preinjury levels at 12-months. Firearm injury was significantly and independently associated with an increased risk of postinjury firearm weapon carriage [relative risk = 2.08, 95% confidence interval (1.34, 3.22), P < 0.01] and higher PTSD symptom levels [Beta = 3.82, 95% confidence interval (1.29, 6.35), P < 0.01]. CONCLUSIONS Firearm injury survivors are at risk for firearm carriage and high PTSD symptom levels postinjury. The significant decrease in the high-risk behavior of firearm weapon carriage at 3-6 months postinjury suggests that there is an important postinjury "teachable moment" that should be targeted with preventive interventions. TRIAL REGISTRATION ClinicalTrials.gov NCT02655354.

ObjectivesAssess the impacts of the COVID-19 pandemic on service delivery by frontline healthcare providers in acute care medical and emergency department settings and identify strategies used to cope with pandemic-related physical and mental health demands.DesignRapid clinical ethnography of patient–provider encounters during an initial pandemic ‘surge’ conducted by a team of clinician–researchers using a structured protocol for qualitative data collection and analysis.SettingLevel 1 trauma centre at Harborview Hospital in Seattle Washington in April 2020.ParticipantsFrontline clinical providers serving as participant observers during performance of their clinical duties recorded observations and summaries of conversations with other providers and patients.ResultsWe identified four different kinds of impacts: procedural, provider, patient and overall. Each impact highlighted two or more levels of a socioecological model of services delivery: (1) the epidemiology of COVID-19, (2) outer setting, (3) inner or organisational setting and (4) individual patient and provider. Despite significant changes in procedures that included COVID-19 screening of all admitted patients, social distancing and use of personal protective equipment, as well as changes in patient and provider behaviour, the overall impact of the pandemic on the emergency department and acute care service delivery was minimal. This is attributed to having a smaller surge than expected, a quick response by the healthcare system to anticipated demands for service delivery and protection of patients and providers, adequate supplies and high provider morale.ConclusionsAlthough limited to one setting in one healthcare system in one community, the findings offer some important lessons for healthcare systems that have yet to be impacted as well as systems that have been more severely impacted. Each of the socioecological framework levels was found to impact service delivery to patients, and variations at each of these levels account for variations in that quality of care globally.

ObjectiveThe Coronavirus disease (COVID-19) outbreak has evolved into a pandemic crisis, with King County in Washington State emerging as the early US epicenter. A literature review revealed few reports providing front-line clinical and research teams guidance related to multilevel, rapidly evolving COVID-19 directives.MethodThe Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method was used to develop a clinical case series and conduct participant observation during an ongoing comparative effectiveness trial of peer-integrated, patient-centered interventions after traumatic injury. Participants were patients enrolled in the intervention arm of the ongoing trial, as well as front-line clinicians, patient peer interventionists, and clinical research team members implementing the trial. All participants were exposed to the Washington State COVID-19 outbreak.ResultsPrimary and secondary COVID-19 prevention strategies were feasibly integrated into ongoing care coordination and behavioral interventions for at-risk patients. Beyond the compilation of case studies, as an iterative method, RAPICE data collection naturalistically evolved to include observations of intervention team activity occurring within the larger pandemic epicenter context. A daily clinical research team huddle that flexibly accommodated virtual participation was also feasibly implemented.ConclusionsPrimary and secondary COVID-19 prevention strategies can be feasibly integrated into ongoing clinical interventions during the pandemic. Routine, proactive clinical and research team communication that transparently addresses ethical tensions and health-sustaining activities may promote well-being for providers grappling with rapidly evolving pandemic directives. Proactive assessments of individual provider vulnerabilities for severe COVID-19 related respiratory illness may also be a crucial element of the health care system pandemic responses.

Annually approximately 2–3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: ( Clinicaltrials.gov NCT03569878 ).

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

Venlafaxine is a structurally novel, nontricyclic compound that is being evaluated for the treatment of various depressive disorders. A randomized three-period crossover study was conducted to obtain pharmacokinetic and dose proportionality data on the drug and its active metabolite, O-desmethylvenlafaxine. Eighteen healthy young men received single doses of venlafaxine 25, 75, and 150 mg followed by 3 days of administration every 8 hours (q8h). Steady-state elimination half-life was 3 to 4 hours for venlafaxine and 10 hours for O-desmethylvenlafaxine; both were independent of dose. Venlafaxine had a high oral-dose clearance, ranging from 0.58 to 2.63 L/hr/kg across doses with the lowest mean clearance, 0.98 L/hr/kg, at the highest dose. The apparent clearance of O-desmethylvenlafaxine was lower than venlafaxine, ranging from 0.21 to 0.66 L/hr/kg, and the lowest mean clearance, 0.33 L/hr/kg, occurred at the lowest dose. The area under the metabolite curve was two to three times greater than that for venlafaxine. Each compound had linear dose proportionality up to 75 mg q8h. A composite parameter incorporating venlafaxine plus O-desmethylvenlafaxine was introduced (i.e., AUC [area under the curve] + activity factor.AUCm), which extended linearity to 150 mg q8h. In summary, venlafaxine is a high-clearance drug that forms a metabolite with almost equal activity and demonstrates linear dose-proportionality.