User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial.

OBJECTIVE: To determine the effect of a user centered clinical decision support tool versus usual care on rates of initiation of buprenorphine in the routine emergency care of individuals with opioid use disorder. DESIGN: Pragmatic cluster randomized controlled trial (EMBED). SETTING: 18 emergency department clusters across five healthcare systems in five states representing the north east, south east, and western regions of the US, ranging from community hospitals to tertiary care centers, using either the Epic or Cerner electronic health record platform. PARTICIPANTS: 599 attending emergency physicians caring for 5047 adult patients presenting with opioid use disorder. INTERVENTION: A user centered, physician facing clinical decision support system seamlessly integrated into user workflows in the electronic health record to support initiating buprenorphine in the emergency department by helping clinicians to diagnose opioid use disorder, assess the severity of withdrawal, motivate patients to accept treatment, and complete electronic health record tasks by automating clinical and after visit documentation, order entry, prescribing, and referral. MAIN OUTCOME MEASURES: Rate of initiation of buprenorphine (administration or prescription of buprenorphine) in the emergency department among patients with opioid use disorder. Secondary implementation outcomes were measured with the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. RESULTS: 1 413 693 visits to the emergency department (775 873 in the intervention arm and 637 820 in the usual care arm) from November 2019 to May 2021 were assessed for eligibility, resulting in 5047 patients with opioid use disorder (2787 intervention arm, 2260 usual care arm) under the care of 599 attending physicians (340 intervention arm, 259 usual care arm) for analysis. Buprenorphine was initiated in 347 (12.5%) patients in the intervention arm and in 271 (12.0%) patients in the usual care arm (adjusted generalized estimating equations odds ratio 1.22, 95% confidence interval 0.61 to 2.43, P=0.58). Buprenorphine was initiated at least once by 151 (44.4%) physicians in the intervention arm and by 88 (34.0%) in the usual care arm (1.83, 1.16 to 2.89, P=0.01). CONCLUSIONS: User centered clinical decision support did not increase patient level rates of initiating buprenorphine in the emergency department. Although streamlining and automating electronic health record workflows can potentially increase adoption of complex, unfamiliar evidence based practices, more interventions are needed to look at other barriers to the treatment of addiction and increase the rate of initiating buprenorphine in the emergency department in patients with opioid use disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658642.

Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial.

BACKGROUND: This update describes changes to the Brief Educational Tool to Enhance Recovery (BETTER) trial in response to the COVID-19 pandemic. METHODS/DESIGN: The original protocol was published in Trials. Due to the COVID-19 pandemic, the BETTER trial converted to remote recruitment in April 2020. All recruitment, consent, enrollment, and randomization now occur by phone within 24 h of the acute care visit. Other changes to the original protocol include an expansion of inclusion criteria and addition of new recruitment sites. To increase recruitment numbers, eligibility criteria were expanded to include individuals with chronic pain, non-daily opioid use within 2 weeks of enrollment, presenting musculoskeletal pain (MSP) symptoms for more than 1 week, hospitalization in past 30 days, and not the first time seeking medical treatment for presenting MSP pain. In addition, recruitment sites were expanded to other emergency departments and an orthopedic urgent care clinic. CONCLUSIONS: Recruiting from an orthopedic urgent care clinic and transitioning to remote operations not only allowed for continued participant enrollment during the pandemic but also resulted in some favorable outcomes, including operational efficiencies, increased enrollment, and broader generalizability. TRIAL REGISTRATION: ClinicalTrials.gov NCT04118595 . Registered on October 8, 2019.

Advance Care Planning for Emergency Department Patients With COVID-19 Infection: An Assessment of a Physician Training Program.

OBJECTIVE: Coronavirus Disease 2019 (COVID-19) has heightened the importance of advance care planning (ACP), particularly in the emergency department (ED). The objective of this study was to determine the effect of an educational program for emergency physicians on ACP conversations in the ED during the COVID-19 pandemic. DESIGN: This was an observational pre-/post-interventional study. SETTING: This study was conducted at a Southeastern U.S. academic ED. PARTICIPANTS: 143 patients with confirmed COVID-19 infection in the 2 weeks up to and including the ED encounter of interest (between March 26 and May 25, 2020) were included. INTERVENTIONS: The primary intervention was an ACP training toolkit with three components: (1) an evidence-based guide to COVID-19 risk stratification, (2) education on language to initiate ACP conversations, and (3) modification of the electronic health record (EHR) to facilitate ACP documentation. Palliative care physicians also delivered a 60-minute ACP educational session for emergency medicine physicians. OUTCOME MEASURES: The primary outcome was a composite of ACP activities including: (1) identification of a healthcare decision-maker (HCDM), (2) an order for a code status, or (3) a documented goals of care conversation. RESULTS: There was a 25.4% (95% CI: 7.0-43.9) increase in the composite outcome of ED-based ACP. After adjustment for patient demographics and triage score, there was a non-statistically significant increase in ACP activity (OR = 2.71, 95% CI: 0.93-8.64; P = .08). CONCLUSION: A rapid and simple physician-facing educational intervention demonstrated a trend, though lacking in statistical significance, towards increased ED-based ACP activities for patients with COVID-19.

Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis.

OBJECTIVES: To characterise current COVID-19-related research activities. DESIGN: Cross-sectional analysis. SETTING: Clinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19. DATA SOURCES: ClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic. MAIN OUTCOME MEASURES: We classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date. RESULTS: Of the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020. CONCLUSIONS: These findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.

Trends in Emergency Department Visits and Hospital Admissions in Health Care Systems in 5 States in the First Months of the COVID-19 Pandemic in the US.

Importance: As coronavirus disease 2019 (COVID-19) spread throughout the US in the early months of 2020, acute care delivery changed to accommodate an influx of patients with a highly contagious infection about which little was known. Objective: To examine trends in emergency department (ED) visits and visits that led to hospitalizations covering a 4-month period leading up to and during the COVID-19 outbreak in the US. Design, Setting, and Participants: This retrospective, observational, cross-sectional study of 24 EDs in 5 large health care systems in Colorado (n = 4), Connecticut (n = 5), Massachusetts (n = 5), New York (n = 5), and North Carolina (n = 5) examined daily ED visit and hospital admission rates from January 1 to April 30, 2020, in relation to national and the 5 states' COVID-19 case counts. Exposures: Time (day) as a continuous variable. Main Outcomes and Measures: Daily counts of ED visits, hospital admissions, and COVID-19 cases. Results: A total of 24 EDs were studied. The annual ED volume before the COVID-19 pandemic ranged from 13 000 to 115 000 visits per year; the decrease in ED visits ranged from 41.5% in Colorado to 63.5% in New York. The weeks with the most rapid rates of decrease in visits were in March 2020, which corresponded with national public health messaging about COVID-19. Hospital admission rates from the ED were stable until new COVID-19 case rates began to increase locally; the largest relative increase in admission rates was 149.0% in New York, followed by 51.7% in Massachusetts, 36.2% in Connecticut, 29.4% in Colorado, and 22.0% in North Carolina. Conclusions and Relevance: From January through April 2020, as the COVID-19 pandemic intensified in the US, temporal associations were observed with a decrease in ED visits and an increase in hospital admission rates in 5 health care systems in 5 states. These findings suggest that practitioners and public health officials should emphasize the importance of visiting the ED during the COVID-19 pandemic for serious symptoms, illnesses, and injuries that cannot be managed in other settings.