Publications by authors named "Timothy F Platts-Mills"

135 Publications

Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials.

BMC Med Res Methodol 2021 06 8;21(1):120. Epub 2021 Jun 8.

Quantworks, Inc, 202 S. Greensboro St, Carrboro, NC, 27510, USA.

Background: Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown.

Methods: This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO's established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results.

Results: Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16-76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9-34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%).

Conclusions: Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.
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http://dx.doi.org/10.1186/s12874-021-01324-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8185489PMC
June 2021

A hybrid model of acute unscheduled cancer care provided by a hospital-based acute care clinic and the emergency department: a descriptive study.

Support Care Cancer 2021 Jun 5. Epub 2021 Jun 5.

Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.

Purpose: Patients with cancer often experience medical events that require immediate evaluation. These evaluations typically occur in an emergency department (ED), but there is increasing interest in providing this care in other settings. We report on a novel care model whereby a nursing hotline is used to triage patients to the ED or to the North Carolina Cancer Hospital Infusion Center (NCCHIC).

Methods: A retrospective study of adult patients with a neoplasm diagnosis seeking acute care at a large academic hospital pre- and post-initiation of the novel care model in January of 2016. Patients were identified by querying the electronic medical record and clinic administrative data during matched 6 month pre- and post-periods.

Results: During the pre-initiation period, 1346 patients visited the ED on 1651 occasions (76.1% admission rate). In the post-initiation period, 1434 patients visited the ED on 1797 occasions (81.5% admission rate), and 246 patients visited the NCCHIC on 322 occasions (68.9% admission rate). The emergency severity index (ESI) in the pre-initiation ED group was primarily ESI 2 (30.6%) and ESI 3 (65.4%). In the post-initiation ED group, the ESI was similar (32.6% ESI 2 and 64.2% ESI 3). In contrast, the NCCHIC predominantly treated lower acuity patients (65.8% calculated ESI of 4/5).

Conclusions: This model demonstrates a multidisciplinary partnership to providing acute unscheduled care for patients with cancer. In the early implementation phase of this model, approximately 15% of patients, generally of lower acuity, were seen in the NCCHIC.
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http://dx.doi.org/10.1007/s00520-021-06327-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178031PMC
June 2021

Forecasting emergency department hourly occupancy using time series analysis.

Am J Emerg Med 2021 Apr 29;48:177-182. Epub 2021 Apr 29.

Department of Statistics and Operations Research, University of North Carolina at Chapel Hill (UNC), NC, USA. Electronic address:

Study Objective: To develop a novel predictive model for emergency department (ED) hourly occupancy using readily available data at time of prediction with a time series analysis methodology.

Methods: We performed a retrospective analysis of all ED visits from a large academic center during calendar year 2012 to predict ED hourly occupancy. Due to the time-of-day and day-of-week effects, a seasonal autoregressive integrated moving average with external regressor (SARIMAX) model was selected. For each hour of a day, a SARIMAX model was built to predict ED occupancy up to 4-h ahead. We compared the resulting model forecast accuracy and prediction intervals with previously studied time series forecasting methods.

Results: The study population included 65,132 ED visits at a large academic medical center during the year 2012. All adult ED visits during the first 265 days were used as a training dataset, while the remaining ED visits comprised the testing dataset. A SARIMAX model performed best with external regressors of current ED occupancy, average department-wide ESI, and ED boarding total at predicting up to 4-h-ahead ED occupancy (Mean Square Error (MSE) of 16.20, and 64.47 for 1-hr- and 4-h- ahead occupancy, respectively). Our 24-SARIMAX model outperformed other popular time series forecasting techniques, including a 60% improvement in MSE over the commonly used rolling average method, while maintaining similar prediction intervals.

Conclusion: Accounting for current ED occupancy, average department-wide ESI, and boarding total, a 24-SARIMAX model was able to provide up to 4 h ahead predictions of ED occupancy with improved performance characteristics compared to other forecasting methods, including the rolling average. The prediction intervals generated by this method used data readily available in most EDs and suggest a promising new technique to forecast ED occupancy in real time.
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http://dx.doi.org/10.1016/j.ajem.2021.04.075DOI Listing
April 2021

Using malnutrition and food insecurity screening to identify broader health-related social needs amongst older adults receiving emergency department care in the Southeastern United States: A cross-sectional study.

Health Soc Care Community 2021 Apr 6. Epub 2021 Apr 6.

Quantworks, Inc, Carrboro, NC, USA.

Unmet health-related social needs are common amongst older US adults and impact both quality of life and health outcomes. One of the ways that unmet health-related social needs impact health is through malnutrition, an imbalance in a person's intake of energy and/or nutrients. Lack of reliable access to a sufficient quantity of nutritious food is a specific health-related social need that can be assessed rapidly and, when unmet, is a direct risk factor for malnutrition and may be indicative of a broader range of unmet health-related social needs. We conducted a cross-sectional study to characterise malnutrition and food insecurity amongst older adults receiving emergency department (ED) care using brief, validated measures and to assess the burden of a broader range of health-related social needs amongst these patients. Patients were asked about their need for and willingness to receive a range of social services. The study was conducted in an academic ED serving a racially and socioeconomically diverse population in the Southeastern United States. A convenience sample of noncritically ill adults aged 60 years and older was approached between November 2018 and April 2019. Study patients (n = 127) were predominantly non-Hispanic white (67%), community dwelling (91%) and urban residents (66%) with 28% screening positive for malnutrition risk, 16% for food insecurity and 5% for both. Of those at risk for malnutrition, 25 (69%) reported ≥2 unmet health-related social needs and 14 (38%) were receptive to social services. Amongst food insecure patients, 18 (90%) reported additional unmet health-related social needs and 13 (65%) were receptive to receiving social services. In conclusion, a brief set of questions can identify subgroups of older ED patients who are food insecure or at risk for malnutrition. Individuals who screen positive for food insecurity have a high burden of unmet health-related social needs.
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http://dx.doi.org/10.1111/hsc.13367DOI Listing
April 2021

Research priorities for elder abuse screening and intervention: A Geriatric Emergency Care Applied Research (GEAR) network scoping review and consensus statement.

J Elder Abuse Negl 2021 Mar-May;33(2):123-144. Epub 2021 Apr 2.

Quantworks, Inc, Healthcare and Life Sciences, Carrboro, North Carolina, USA.

The Geriatric Emergency Care Applied Research (GEAR) Network (1) conducted a scoping review of the current literature on the identification of and interventions to address elder abuse among patients receiving care in emergency departments and (2) used this review to prioritize research questions for knowledge development. Two questions guided the scoping review: What is the effect of universal emergency department screening compared to targeted screening or usual practice on cases of elder abuse identified, safety outcomes, and health care utilization?; and What is the safety, health, legal, and psychosocial impact of emergency department-based interventions vs. usual care for patients experiencing elder abuse? We searched five article databases. Additional material was located through reference lists of identified publications, PsychInfo, and Google Scholar. The results were discussed in a consensus conference; and stakeholders voted to prioritize research questions. No studies were identified that directly addressed the first question regarding assessment strategies, but four instruments used for elder abuse screening in the emergency department were identified. For the second question, we located six articles on interventions for elder abuse in the emergency department; however, none directly addressed the question of comparative effectiveness. Based on these findings, GEAR participants identified five questions as priorities for future research - two related to screening, two related to intervention, and one encompassed both. In sum, research to identify best practices for elder abuse assessment and intervention in emergency departments is still needed. Although there are practical and ethical challenges, rigorous experimental studies are needed.
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http://dx.doi.org/10.1080/08946566.2021.1904313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204570PMC
April 2021

Characteristics, clinical care, and disposition barriers for mental health patients boarding in the emergency department.

Am J Emerg Med 2020 Nov 12. Epub 2020 Nov 12.

UNC School of Medicine, UNC Chapel Hill, Chapel Hill, NC, United States of America. Electronic address:

Background And Objectives: Lack of mental health resources, such as inpatient psychiatric beds, has increased frequency and duration of boarding for mental health patients presenting to U.S. emergency departments (EDs). The purpose of this study is to describe characteristics of mental health patients with an ED length of stay of one week or longer and to identify barriers to their disposition.

Methods: This study was conducted in an academic ED in which emergency psychiatric evaluations and care are provided by a Psychiatric Emergency Services (PES) team contained within the Department of Emergency Medicine. Prolonged boarding was defined as an ED length of stay of 7 days or more. Pediatric, adult, and geriatric mental health patients with prolonged ED boarding from January 1 to August 31, 2019 were included. This study includes prospective data collection of the boarding group and retrospective identification and data collection of a comparison group of non-barding patients over the same 8-month period to compare patient characteristics and outcomes for each group.

Results: Between January 1 and August 31, 2019, the PES team completed 2,745 new assessments of mental health patients, of whom 39 met criteria for prolonged ED boarding. The following characteristics were associated with boarding: child (8%), male (64%), having Medicaid (49%) or both Medicaid and Medicare (18%), and having either a neurodevelopmental (15%) or neurocognitive disorder (15%) with a median stay of 18 days. Barriers to discharge included being declined from all state inpatient psychiatric hospitals (69%), declined from community living environments (21%), or declined from both (10%). The most common ED non-boarding patients were: Caucasian (64%), have a diagnosis of unspecified mental disorder (including suicidal ideation) or other specified mental disorder (59%) and have private insurance (42%) with a median stay of 1 day.

Conclusion: In this study of mental health patients with prolonged ED stays, the primary barrier to disposition was the lack of patient acceptance to inpatient psychiatric hospitals, community settings, or other housing. Early identification of potential prolonged boarding, quality treatment and care for those patients, and effective case management, may resolve the ongoing challenges of boarding within the ED.
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http://dx.doi.org/10.1016/j.ajem.2020.11.021DOI Listing
November 2020

Identification and characterization of older emergency department patients with high-risk alcohol use.

J Am Coll Emerg Physicians Open 2020 Oct 17;1(5):804-811. Epub 2020 Jul 17.

Department of Emergency Medicine Yale School of Medicine New Haven Connecticut USA.

Background: High-risk alcohol use in the elderly is a common but underrecognized problem. We tested a brief screening instrument to identify high-risk individuals.

Methods: This was a prospective, cross-sectional study conducted at a single emergency department. High-risk alcohol use was defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines as >7 drinks/week or >3 drinks/occasion. We assessed alcohol use in patients aged ≥ 65 years using the timeline follow back (TLFB) method as a reference standard and a new, 2-question screener based on NIAAA guidelines. The Alcohol Use Disorders Identification Test (AUDIT) and Cut down, Annoyed, Guilty, Eye-opener (CAGE) screens were used for comparison. We collected demographic information from a convenience sample of high- and low-risk drinkers.

Results: We screened 2250 older adults and 180 (8%) met criteria for high-risk use. Ninety-eight high-risk and 124 low-risk individuals were enrolled. The 2-question screener had sensitivity of 98% (95% CI, 93%-100%) and specificity of 87% (95% CI, 80%-92%) using TLFB as the reference. It had higher sensitivity than the AUDIT or CAGE tools. The high-risk group was predominantly male (65% vs 35%, < 0.001). They drank a median of 14 drinks per week across all ages from 65 to 92. They had higher rates of prior substance use treatment (17% vs 2%, < 0.001) and current tobacco use (24% vs 9%, = 0.004).

Conclusion: A rapid, 2-question screener can identify high-risk drinkers with higher sensitivity than AUDIT or CAGE screening. It could be used in concert with more specific questionnaires to guide treatment.
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http://dx.doi.org/10.1002/emp2.12196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7593462PMC
October 2020

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

BMJ Open 2020 09 17;10(9):e041276. Epub 2020 Sep 17.

Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.

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.
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http://dx.doi.org/10.1136/bmjopen-2020-041276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7500290PMC
September 2020

Insurance instability and use of emergency and office-based care after gaining coverage: An observational cohort study.

PLoS One 2020 4;15(9):e0238100. Epub 2020 Sep 4.

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

Background: The Affordable Care Act led to improvements in reporting a usual source of care, but it is unclear whether patients are changing their usual source of care in response to coverage gains. We assess whether prior insurance instability is associated with changes in use of emergency and office-based care after the Marketplace and Medicaid expansion were introduced.

Methods: Our study draws from the 2013-14 Medical Expenditure Panel Survey, identifying a cohort of non-elderly adults with full-year health insurance coverage in 2014. We use linear and multinomial logistic regression to assess the relationship between insurance instability prior to 2014 (uninsured for 1-11 months, ≥12 months) and person-level changes in use of health care after gaining coverage (change in ED and office visits from 2013 to 2014) with continuously insured individuals serving as a comparison group.

Results: Being uninsured for at least one year prior to gaining full-year coverage in 2014 was associated with a 33% increase in ED visits (0.06 visits, p<0.01) and a 47% increase in office visits (1.10 visits, p<0.01), driven by those gaining public coverage. We found no evidence of substitution across settings in the short term, often a stated goal of expansion.

Conclusion: The long-term uninsured may have substantial health needs and pent-up demand for health care, seeing more physicians across multiple settings in the year after gaining coverage as they seek to get unmanaged conditions under control. Closing the gap in primary care use between the previously uninsured and those with health insurance coverage may help improve long-term health outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238100PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473517PMC
October 2020

Multicenter Validation of an Emergency Department-Based Screening Tool to Identify Elder Abuse.

Ann Emerg Med 2020 09;76(3):280-290

Department of Emergency Medicine, Cooper Medical School of Rowan University, Camden, NJ.

Study Objective: Emergency department (ED) visits provide an important opportunity for elder abuse identification. Our objective was to assess the accuracy of the ED Senior Abuse Identification (ED Senior AID) tool for the identification of elder abuse.

Methods: We conducted a study of the ED Senior AID tool in 3 US EDs. Participants were English-speaking patients 65 years old and older who provided consent or for whom a legally authorized representative provided consent. Research nurses administered the screening tool, which includes a brief mental status assessment, questions about elder abuse, and a physical examination for patients who lack the ability to report abuse or for whom the presence or absence of abuse was uncertain. The reference standard was based on the majority opinion of a longitudinal, expert, all data (LEAD) panel following review and discussion of medical records, clinical social worker notes, and a structured social and behavioral evaluation. For the reference standard, LEAD panel members were blinded to the results of the screening tool.

Results: Of 916 enrolled patients, 33 (3.6%) screened positive for elder abuse. The LEAD panel reviewed 125 cases: all 33 with positive screen results and a 10% random sample of negative screen results. Of these, the panel identified 17 cases as positive for elder abuse, including 16 of the 33 cases that screened positive. The ED Senior AID tool had a sensitivity of 94.1% (95% confidence interval [CI] 71.3% to 99.9%) and specificity of 84.3% (95% CI 76.0% to 90.6%).

Conclusion: This multicenter study found the ED Senior AID tool to have a high sensitivity and specificity as a screening tool for elder abuse, albeit with wide CIs.
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http://dx.doi.org/10.1016/j.annemergmed.2020.07.005DOI Listing
September 2020

Strengthening Our Intuition About Elder Abuse.

Ann Emerg Med 2020 09 23;76(3):277-279. Epub 2020 May 23.

Department of Emergency Medicine, University of North Carolina, Chapel Hill, NC.

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http://dx.doi.org/10.1016/j.annemergmed.2020.05.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245310PMC
September 2020

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.

JAMA Intern Med 2020 10;180(10):1328-1333

Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut.

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.
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http://dx.doi.org/10.1001/jamainternmed.2020.3288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400214PMC
October 2020

Self-Reported Opioid Use and Driving Outcomes among Older Adults: The AAA LongROAD Study.

J Am Board Fam Med 2020 Jul-Aug;33(4):521-528

From the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (MEB, JH); Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora (HH, CD); Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill (TFPM); Bassett Research Institute, Cooperstown, NY (DS); Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY (HFA); Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY (HFA); Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY (TJM, GI); Department of Family Medicine and Public Health, University of California-San Diego, La Jolla (LLH); Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD (VJ); University of Michigan Transportation Research Institute and the Center for Advancing Transportation Leadership and Safety (ATLAS Center), Ann Arbor (LJM, DWE); Department of Anesthesiology, Columbia University-Vagelos College of Physicians and Surgeons, New York, NY (GI).

Background: Opioid medications are important therapeutic options to mitigate the harmful effects of pain but can also impair driving ability. We sought to explore opioid use, pain levels, and driving experiences among older drivers.

Methods: Cognitively intact drivers ages 65 to 79 years were recruited for the multisite AAA Longitudinal Research on Aging Drivers (LongROAD) study (n = 2990). This cross-sectional analysis used data from the baseline questionnaire and "brown-bag" medication review.

Results: Among LongROAD participants (47% male, 88% white, 41% aged 65 to 69 years), 169 (5.7%) reported currently taking an opioid, with a median daily dose of 20 morphine milligram equivalents. Participants did not differ significantly in opioid use by age, gender, race, or ethnicity ( > .05). After adjustment for age, gender, race and ethnicity, participants who were taking opioids (vs not) were significantly more likely to report self-regulated driving reduction and reduced driving ability. However, these effects became nonsignificant when hospitalization, impaired physical function and other factors associated with opioid use were controlled.

Conclusions: In this study from a large, geographically diverse sample of older adults, there was an association between opioid use and several self-reported measures of driving behavior and ability. However, future work should clarify the effects on driving of opioid use from the effects of the painful medical conditions for which the opioids are being taken. Clinicians should continue to discuss the risks and benefits of opioid medications with patients, including risks related to driving safety.
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http://dx.doi.org/10.3122/jabfm.2020.04.190429DOI Listing
November 2019

Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial.

Trials 2020 Jul 6;21(1):615. Epub 2020 Jul 6.

Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.

Background: Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).

Methods: Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.

Discussion: This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.

Trial Registration: ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019.
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http://dx.doi.org/10.1186/s13063-020-04552-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336469PMC
July 2020

Screening for elder mistreatment in emergency departments: current progress and recommendations for next steps.

J Elder Abuse Negl 2020 06;32(3):295-315

The John A. Hartford Foundation , New York, NY, USA.

Emergency Department (ED) visits provide an important but seldom realized opportunity to identify elder mistreatment. Many screening tools exist, including several that are brief and may be effective, but few have been specifically designed for or tested in EDs. In addition to the absence of validated tools, other challenges with implementing ED elder mistreatment screening include difficulty integrating anything longer than a few questions into a busy clinical encounter and resources required to respond to positive screens. The Electronic Health Record (EHR) offers a critical tool to facilitate elder mistreatment screening through required data entry and real-time monitoring of compliance and results. We describe current work in the field and recommend next steps including design and testing of a two-step screening process, implementation research to accelerate adoption, development of ED-based interventions and referral protocols for positive cases, and consideration of the important role of pre-hospital providers in case identification.
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http://dx.doi.org/10.1080/08946566.2020.1768997DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520626PMC
June 2020

Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder.

J Psychiatr Brain Sci 2020 21;5. Epub 2020 Feb 21.

Department of Emergency Medicine, Yale University School of Medicine, New Haven, CT 06519, USA.

Buprenorphine (BUP) can safely and effectively reduce craving, overdose, and mortality rates in people with opioid use disorder (OUD). However, adoption of ED-initiation of BUP has been slow partly due to physician perception this practice is too complex and disruptive. We report progress of the ongoing EMBED ( project. This project is a five-year collaboration across five healthcare systems with the goal to develop, integrate, study, and disseminate user-centered Clinical Decision Support (CDS) to promote the adoption of Emergency Department (ED)-initiation of buprenorphine/naloxone (BUP) into routine emergency care. Soon to enter its third year, the project has already completed multiple milestones to achieve its goals including (1) user-centered design of the CDS prototype, (2) integration of the CDS into an automated electronic health record (EHR) workflow, (3) data coordination including derivation and validation of an EHR-based computable phenotype, (4) meeting all ethical and regulatory requirements to achieve a waiver of informed consent, (5) pilot testing of the intervention at a single site, and (6) launching a parallel group-randomized 18-month pragmatic trial in 20 EDs across 5 healthcare systems. Pilot testing of the intervention in a single ED was associated with increased rates of ED-initiated BUP and naloxone prescribing and a doubling of the number of unique physicians adopting the practice. The ongoing multi-center pragmatic trial will assess the intervention's effectiveness, scalability, and generalizability with a goal to shift the emergency care paradigm for OUD towards early identification and treatment.

Trial Registration: Clinicaltrials.gov # NCT03658642.
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http://dx.doi.org/10.20900/jpbs.20200003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7164817PMC
February 2020

Leveraging emergency department visits to connect older adults at risk for malnutrition and food insecurity to community resources: design and protocol development for the BRIDGE study.

Pilot Feasibility Stud 2020 3;6:36. Epub 2020 Mar 3.

2Department of Emergency Medicine, University of North Carolina, 170 Manning Drive CB #7594, Chapel Hill, NC 27599 USA.

Background: Malnutrition is a complex and costly condition that is common among older adults in the United States (US), with up to half at risk for malnutrition. Malnutrition is associated with several non-medical (i.e., social) factors, including food insecurity. Being at risk for both malnutrition and food insecurity likely identifies a subset of older adults with complex care needs and a high burden of social vulnerability (e.g., difficulty accessing or preparing meals, lack of transportation, and social isolation). US emergency departments (EDs) are a unique and important setting for identifying older patients who may benefit from the provision of health-related social services. This paper describes the protocol development for the Building Resilience and InDependence for Geriatric Patients in the Emergency Department (BRIDGE) study. BRIDGE was designed to assess the feasibility of an ED-based screening process to systematically identify older patients who are at risk for malnutrition and food insecurity and link them to health-related social services to address unmet social needs and support their health and well-being.

Methods: Phase 1 efforts will be formative and focused on identifying screening tools, establishing screening and referral workflows, and conducting initial feasibility testing with a cohort of older patients and ED staff. In phase 2, which includes process and outcome evaluation, the screening and referral process will be piloted in the ED. A partnership will be formed with an Area Agency on Aging (AAA) identified in phase 1, to assess resource needs and identify community-based social services for older ED patients who screen positive for both malnutrition risk and food insecurity. Data on screening, referrals, linkage to community-based social services, and patient-reported quality of life and healthcare utilization will be used to assess feasibility.

Discussion: The tools and workflows developed and tested in this study, as well as learnings related to forming and maintaining cross-sector partnerships, may serve as a model for future efforts to utilize EDs as a setting for bridging the gap between healthcare and social services for vulnerable patients.
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http://dx.doi.org/10.1186/s40814-020-00576-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055061PMC
March 2020

Modernizing Informed Consent During Emergency Care.

Ann Emerg Med 2020 09 17;76(3):350-352. Epub 2020 Jan 17.

Department of Emergency Medicine, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC.

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http://dx.doi.org/10.1016/j.annemergmed.2019.11.021DOI Listing
September 2020

Ability of Older Adults to Report Elder Abuse: An Emergency Department-Based Cross-Sectional Study.

J Am Geriatr Soc 2020 01;68(1):170-175

Department of Emergency Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Objectives: To characterize assessments of a patient's ability to report elder abuse within the context of an emergency department (ED)-based screen for elder abuse.

Design: Cross-sectional study in which participants were screened for elder abuse and neglect.

Setting: Academic ED in the United States.

Participants: Patients, aged 65 years and older, presenting to an ED for acute care were assessed by trained research assistants or nurses.

Measurements: All patients completed the four-item Abbreviated Mental Test 4 (AMT4), then completed a safety interview (using the Emergency Department Senior Abuse Identification tool) designed to detect multiple domains of elder abuse and received a physical examination. Based on the cognitive assessment and safety interview, assessors ranked their confidence in the patient's ability to report abuse as absolutely confident, confident, somewhat confident, or not confident. To assess interrater reliability, two assessors independently rated confidence for a subset of patients.

Results: Assessors suspected elder abuse in 18 of 276 patients (6.5%). Assessors were absolutely confident in the patient's ability to report abuse for 95.7% of patients, confident for 2.5%, somewhat confident for 1.5%, and not confident for 0.3%. Among patients with an AMT4 of 4 (n = 249), assessors were confident or absolutely confident in 100% of patients. Among patients with an AMT4 of less than 4 (n = 27), they were confident or absolutely confident in the patient's ability to report abuse for 81% of patients, including 11 of 12 patients with mild cognitive impairment and 7 of 11 patients with severe cognitive impairment. For patients receiving paired evaluations (n = 131), agreement between assessors regarding patient ability to report abuse was 97% (κ = 0.5).

Conclusions: In this sample of older adults receiving care in an ED, research assistants and nurses felt that the vast majority were able to report elder abuse, including many patients with cognitive impairment. J Am Geriatr Soc 68:170-175, 2019.
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http://dx.doi.org/10.1111/jgs.16211DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7110415PMC
January 2020

Tolerance of Uncertainty and the Practice of Emergency Medicine.

Ann Emerg Med 2020 06 23;75(6):715-720. Epub 2019 Dec 23.

Department of Emergency Medicine, Yale-New Haven Hospital, New Haven, CT.

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http://dx.doi.org/10.1016/j.annemergmed.2019.10.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294596PMC
June 2020

Feeling FAINT? Watch Out for the Grizzlies.

Ann Emerg Med 2020 02 19;75(2):159-161. Epub 2019 Dec 19.

Department of Emergency Medicine, University of North Carolina Chapel Hill, Chapel Hill, NC.

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http://dx.doi.org/10.1016/j.annemergmed.2019.10.008DOI Listing
February 2020

Prevalence and Economic Burden of Malnutrition Diagnosis Among Patients Presenting to United States Emergency Departments.

Acad Emerg Med 2021 03 31;28(3):325-335. Epub 2020 Aug 31.

and, Department of Emergency Medicine, University of North Carolina, Chapel Hill, NC.

Background: Malnutrition is a potentially remediable condition that when untreated contributes to poor health and economic outcomes. While assessment of malnutrition risk is improving, its identification rate and economic burden in emergency departments (EDs) is largely unknown. We sought to determine prevalence and economic burden of diagnosed malnutrition among patients presenting to U.S. EDs.

Methods: This is a retrospective analysis of Healthcare Cost and Utilization Project Nationwide Emergency Department Sample data. Malnutrition prevalence was confirmed via International Classification of Diseases, 9th Edition, diagnosis codes. The economic burden was assessed by comparing probability of hospitalization and the average total charges between propensity-score matched visits with and without a malnutrition diagnosis.

Results: Data from 238 million ED visits between 2006 and 2014 were analyzed. Over this period, the prevalence of diagnosed malnutrition increased for all demographic categories assessed. For older adults (≥65 years), the prevalence increased from 2.5% (2006) to 3.6% (2014). Older age, high-income community residence, Western region, urban areas, and Medicare coverage were associated with higher diagnosis prevalence. Malnutrition diagnosis was associated with a 4.23 (95% confidence interval [CI] = 3.93 to 4.55) times higher odds of hospitalization and $21,892 higher mean total charges (95% CI = $19,593 to $24,192).

Conclusions: While malnutrition is currently diagnosed at a low rate in U.S. EDs, the economic burden of malnutrition is substantial in this care setting. Given the potential for systematic malnutrition screening and treatment protocols to alleviate this burden, future research is warranted.
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http://dx.doi.org/10.1111/acem.13887DOI Listing
March 2021

Identifying Opioid Use Disorder in the Emergency Department: Multi-System Electronic Health Record-Based Computable Phenotype Derivation and Validation Study.

JMIR Med Inform 2019 Oct 31;7(4):e15794. Epub 2019 Oct 31.

Department of Emergency Medicine, Yale University School of Medicine, New Haven, CT, United States.

Background: Deploying accurate computable phenotypes in pragmatic trials requires a trade-off between precise and clinically sensical variable selection. In particular, evaluating the medical encounter to assess a pattern leading to clinically significant impairment or distress indicative of disease is a difficult modeling challenge for the emergency department.

Objective: This study aimed to derive and validate an electronic health record-based computable phenotype to identify emergency department patients with opioid use disorder using physician chart review as a reference standard.

Methods: A two-algorithm computable phenotype was developed and evaluated using structured clinical data across 13 emergency departments in two large health care systems. Algorithm 1 combined clinician and billing codes. Algorithm 2 used chief complaint structured data suggestive of opioid use disorder. To evaluate the algorithms in both internal and external validation phases, two emergency medicine physicians, with a third acting as adjudicator, reviewed a pragmatic sample of 231 charts: 125 internal validation (75 positive and 50 negative), 106 external validation (56 positive and 50 negative).

Results: Cohen kappa, measuring agreement between reviewers, for the internal and external validation cohorts was 0.95 and 0.93, respectively. In the internal validation phase, Algorithm 1 had a positive predictive value (PPV) of 0.96 (95% CI 0.863-0.995) and a negative predictive value (NPV) of 0.98 (95% CI 0.893-0.999), and Algorithm 2 had a PPV of 0.8 (95% CI 0.593-0.932) and an NPV of 1.0 (one-sided 97.5% CI 0.863-1). In the external validation phase, the phenotype had a PPV of 0.95 (95% CI 0.851-0.989) and an NPV of 0.92 (95% CI 0.807-0.978).

Conclusions: This phenotype detected emergency department patients with opioid use disorder with high predictive values and reliability. Its algorithms were transportable across health care systems and have potential value for both clinical and research purposes.
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http://dx.doi.org/10.2196/15794DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6913746PMC
October 2019

Patient health literacy and the receipt of opioids in the emergency department.

J Opioid Manag 2019 Jul/Aug;15(4):267-271

Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina.

Objective: Assess relationships between patient health literacy and formal education and use of opioids during and following an emergency department (ED) visit.

Design: Prospective, cross-sectional study.

Setting: Academic ED.

Participants: Adults aged ≥ 60 years presenting to the ED with musculoskeletal pain.

Main Outcome Measures: Opioid use during and after an ED visit.

Results: In a sample of 136 patients, patients with low health literacy were more likely to receive an opioid in the ED than patients with high health literacy (70 percent vs 52 percent; 18 percent difference, 95% confidence interval [CI]: -1 percent, 35 percent), receive an opioid prescription (63 percent vs 44 percent; 19 percent difference, 95% CI: 1 percent, 37 percent), and take opioids during the week following the ED visit (48 percent vs 29 percent; 18 percent difference, 95% CI: 0 percent, 36 percent).

Conclusions: A greater proportion of older adults receiving ED care for musculoskeletal pain with low health literacy receive and use opioids during and following an ED visit.
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http://dx.doi.org/10.5055/jom.2019.0511DOI Listing
October 2019

180-Day functional decline among older patients attending an emergency department after a fall.

Maturitas 2019 Nov 15;129:50-56. Epub 2019 Aug 15.

Emergency Department, Hospital Clínico San Carlos, Madrid, Spain; Complutense University, Madrid, Spain. Electronic address:

Objectives: To determine functional changes and factors affecting 180-day functional prognosis among older patients attending a hospital emergency department (ED) after a fall.

Study Design: Retrospective analysis from a prospective cohort study (FALL-ER Registry) spanning one year that included individuals aged ≥65 years attending four Spanish EDs after a fall. We collected 9 baseline and 6 fall-related factors.

Main Outcome Measures: Barthel Index (BI) was measured at baseline, discharge and 30, 90 and 180 days after the index fall. Absolute and relative BI changes were calculated. Absolute difference of ≥10 points between BI at baseline and at 180 days was considered a clinically significant functional decline.

Results: 452 patients (mean age 80 ± 8 years; 70.8% women) were included. Baseline BI was 79.3 ± 23.1 points. Compared with baseline, functional status was significantly lower at the 4 follow-up time points (-8.7% at discharge; and -6.9%, -7.9% and -9.5% at 30, 90 and 180 days; p < 0.001 for all comparisons in relation to baseline; p = 0.001 for change over time). One hundred and thirty-three (29.6%) patients had a clinically significant functional decline at 180 days. Age ≥85 years (OR = 2.24, 95%CI 1.23-4.08; p = 0.008), fall-related fracture (OR = 2.45, 95%CI 1.43-4.28; p = 0.001), hospitalization (OR = 1.91; 95%CI 1.11-3.29; p = 0.019) and post-fall syndrome (OR = 1.77, 95%CI 1.13-2.77; p = 0.013) were independently associated with 180-day clinically significant functional decline.

Conclusion: Patients ≥65 years attending EDs after a fall experience a consistent and persistent negative impact on their functional status. Several factors may help identify patients at increased risk of functional impairment.
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http://dx.doi.org/10.1016/j.maturitas.2019.08.008DOI Listing
November 2019

The Triage of Older Adults with Physiologic Markers of Serious Injury Using a State-Wide Prehospital Plan.

Prehosp Disaster Med 2019 Oct 13;34(5):497-505. Epub 2019 Sep 13.

Department of Emergency Medicine, University of North Carolina, Chapel Hill, North CarolinaUSA.

Introduction: In January of 2010, North Carolina (NC) USA implemented state-wide Trauma Triage Destination Plans (TTDPs) to provide standardized guidelines for Emergency Medical Services (EMS) decision making. No study exists to evaluate whether triage behavior has changed for geriatric trauma patients.

Hypothesis/problem: The impact of the NC TTDPs was investigated on EMS triage of geriatric trauma patients meeting physiologic criteria of serious injury, primarily based on whether these patients were transported to a trauma center.

Methods: This is a retrospective cohort study of geriatric trauma patients transported by EMS from March 1, 2009 through September 30, 2009 (pre-TTDP) and March 1, 2010 through September 30, 2010 (post-TTDP) meeting the following inclusion criteria: (1) age 50 years or older; (2) transported to a hospital by NC EMS; (3) experienced an injury; and (4) meeting one or more of the NC TTDP's physiologic criteria for trauma (n = 5,345). Data were obtained from the Prehospital Medical Information System (PreMIS). Data collected included proportions of patients transported to a trauma center categorized by specific physiologic criteria, age category, and distance from a trauma center.

Results: The proportion of patients transported to a trauma center pre-TTDP (24.4% [95% CI 22.7%-26.1%]; n = 604) was similar to the proportion post-TTDP (24.4% [95% CI 22.9%-26.0%]; n = 700). For patients meeting specific physiologic triage criteria, the proportions of patients transported to a trauma center were also similar pre- and post-TTDP: systolic blood pressure <90 mmHg (22.5% versus 23.5%); respiratory rate <10 or >29 (23.2% versus 22.6%); and Glascow Coma Scale (GCS) score <13 (26.0% versus 26.4%). Patients aged 80 years or older were less likely to be transported to a trauma center than younger patients in both the pre- and post-TTDP periods.

Conclusions: State-wide implementation of a TTDP had no discernible effect on the proportion of patients 50 years and older transported to a trauma center. Under-triage remained common and became increasingly prevalent among the oldest adults. Research to understand the uptake of guidelines and protocols into EMS practice is critical to improving care for older adults in the prehospital environment.
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http://dx.doi.org/10.1017/S1049023X19004825DOI Listing
October 2019

Increasing the Value of Emergency Visits for Long-term Care Patients: When Less is More and More is More.

J Am Med Dir Assoc 2019 08;20(8):927-928

Cecil G. Sheps Center for Health Services Research and Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.

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http://dx.doi.org/10.1016/j.jamda.2019.06.016DOI Listing
August 2019

Patient Versus Physician Perceptions of Frailty: A Comparison of Clinical Frailty Scale Scores of Older Adults in the Emergency Department.

Acad Emerg Med 2019 09 24;26(9):1089-1092. Epub 2019 Jul 24.

and the, Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO.

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http://dx.doi.org/10.1111/acem.13825DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6732012PMC
September 2019

Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial.

BMJ Open 2019 06 1;9(5):e028694. Epub 2019 Jun 1.

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA.

Introduction: Clinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.

Methods And Analysis: PRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study's trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.

Ethics And Dissemination: The Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.

Trial Registration Number: ISRCTN41225307; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-028694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549750PMC
June 2019

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial.

BMJ Open 2019 05 30;9(5):e028488. Epub 2019 May 30.

Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.

Introduction: The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).

Methods: A pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.

Ethics And Dissemination: The protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.

Trial Registration Number: NCT03658642; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-028488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6550013PMC
May 2019