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 < .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 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 oral healthcare situation for elderly people today is so complex that theoretical education at the group level regarding different aspects of oral health is not sufficient. Individual hands-on guidance by dental hygienists on a regular basis in everyday care may be a new approach.

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.

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INTRODUCTION: Patients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS. METHODS: We published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected. RESULTS: A total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout. CONCLUSION: Our social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.