Successful Optimization of Tobacco Dependence Treatment in the Emergency Department: A Randomized Controlled Trial Using the Multiphase Optimization Strategy.

STUDY OBJECTIVE: Tobacco dependence treatment initiated in the hospital emergency department (ED) is effective. However, trials typically use multicomponent interventions, making it difficult to distinguish specific components that are effective. In addition, interactions between components cannot be assessed. The Multiphase Optimization Strategy allows investigators to identify these effects. METHODS: We conducted a full-factorial, 24 or 16-condition optimization trial in a busy hospital ED to examine the performance of 4 tobacco dependence interventions: a brief negotiation interview; 6 weeks of nicotine replacement therapy with the first dose delivered in the ED; active referral to a telephone quitline; and enrollment in SmokefreeTXT, a free short-messaging service program. Study data were analyzed with a novel mixed methods approach to assess clinical efficacy, cost-effectiveness, and qualitative participant feedback. The primary endpoint was tobacco abstinence at 3 months, verified by exhaled carbon monoxide using a Bedfont Micro+ Smokerlyzer. RESULTS: Between February 2017 and May 2019, we enrolled 1,056 adult smokers visiting the ED. Odd ratios (95% confidence intervals) from the primary analysis of biochemically confirmed abstinence rates at 3 months for each intervention, versus control, were: brief negotiation interview, 1.8 (1.1, 2.8); nicotine replacement therapy, 2.1 (1.3, 3.2); quitline, 1.4 (0.9, 2.2); SmokefreeTXT, 1.1 (0.7, 1.7). There were no statistically significant interactions among components. Economic and qualitative analyses are in progress. CONCLUSION: The brief negotiation interview and nicotine replacement therapy were efficacious. This study is the first to identify components of ED-initiated tobacco dependence treatment that are individually effective. Future work will address the scalability of the brief negotiation interview and nicotine replacement therapy by offering provider-delivered brief negotiation interviews and nicotine replacement therapy prescriptions.

Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults.

AIMS: To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures. DESIGN: Group-randomized longitudinal pilot study. METHODS: In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews. RESULTS: Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (ß = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; ß = 0.71; SE[0.16]; p ≤ 0.0001; ß = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (ß = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs. CONCLUSION: BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population. IMPACT: The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.

Shared decision-making in the BREATHE asthma intervention trial: A research protocol.

AIM: To evaluate the preliminary effectiveness of the BRief Evaluation of Asthma THerapy intervention, a 7-min primary care provider-delivered shared decision-making protocol that uses motivational interviewing to address erroneous asthma disease and medication beliefs. DESIGN: A multi-centre masked two-arm group-randomized clinical trial. METHODS: This 2-year pilot study is funded (September 2016) by the National Institute of Nursing Research. Eight providers will be randomized to one of two arms: the active intervention (N = 4) or a dose-matched attention control (N = 4). Providers will deliver the intervention to which they were randomized to 10 Black adult patients with uncontrolled asthma (N = 80). Patients will be followed three months postintervention to test the preliminary intervention effects on asthma control (primary outcome) and on medication adherence, lung function, and asthma-related quality of life (secondary outcomes). DISCUSSION: This study will evaluate the preliminary impact of a novel shared decision-making intervention delivered in a real world setting to address erroneous disease and medication beliefs as a means of improving asthma control in Black adults. Results will inform a future, large-scale randomized trial with sufficient power to test the intervention's effectiveness. IMPACT: Shared decision-making is an evidence-based intervention with proven effectiveness when implemented in the context of labour- and time-intensive research protocols. Medication adherence is linked with the marked disparities evident in poor and minority adults with asthma. Addressing this requires a novel multifactorial approach as we have proposed. To ensure sustainability, shared decision-making interventions must be adapted to and integrated into real-world settings. TRIAL REGISTRATION: Registered at clincialtrials.gov as NCT03036267 and NCT03300752.

Use of non-face-to-face modalities for emergency department screening, brief intervention, and referral to treatment (ED-SBIRT) for high-risk alcohol use: A scoping review.

Background: The purpose of this review was to examine and chart the "scope" of strategies reported in ED-SBIRT (emergency department-based screening, brief intervention and referral to treatment) studies that employ non-face-to-face (nFtF) modalities for high-risk alcohol use (i.e., risk for alcohol-related injury, medical condition, use disorder) and to identify research gaps in the scientific literature. Methods: The scoping review population included study participants with high-risk alcohol use patterns as well as study participants targeted for primary public health prevention (e.g., adolescent ED patients). Core concepts included SBIRT components among intervention studies that incorporated some form of nFtF modality (e.g., computer-assisted brief intervention). The context encompassed ED-based studies or trauma center studies, regardless of geographic location. After screening a total of 1526 unique references, reviewers independently assessed 58 full-text articles for eligibility. Results: A total of 30 full-text articles were included. Articles covered a period of 14 years (2003-2016) and 19 journal titles. Authors reported the use of a wide range of nFtF modalities across all 3 ED-SBIRT components: "screening" (e.g., computer tablet screening), "brief intervention" (e.g., text message-based brief interventions), and "referral to treatment" (e.g., computer-generated feedback with information about alcohol treatment services). The most frequently used nFtF modality was computerized screening and/or baseline assessment. The main results were mixed with respect to showing evidence of ED-SBIRT intervention effects. Conclusions: There is an opportunity for substance use disorder researchers to explore the specific needs of several populations (e.g., ED patients with co-occurring problems such as substance use disorder and violence victimization) and on several methodological issues (e.g., ED-SBIRT theory of change). Substance use disorder researchers should take the lead on establishing guidelines for the reporting of ED-SBIRT studies-including categorization schemes for various nFtF modalities. This would facilitate both secondary research (e.g., meta-analyses) and primary research design.

Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention.

BACKGROUND: Emergency department (ED)-initiated buprenorphine/naloxone with continuation in primary care was found to increase engagement in addiction treatment and reduce illicit opioid use at 30 days compared to referral only or a brief intervention with referral. OBJECTIVE: To evaluate the long-term outcomes at 2, 6 and 12 months following ED interventions. DESIGN: Evaluation of treatment engagement, drug use, and HIV risk among a cohort of patients from a randomized trial who completed at least one long-term follow-up assessment. PARTICIPANTS: A total of 290/329 patients (88% of the randomized sample) were included. The followed cohort did not differ significantly from the randomized sample. INTERVENTIONS: ED-initiated buprenorphine with 10-week continuation in primary care, referral, or brief intervention were provided in the ED at study entry. MAIN MEASURES: Self-reported engagement in formal addiction treatment, days of illicit opioid use, and HIV risk (2, 6, 12 months); urine toxicology (2, 6 months). KEY RESULTS: A greater number of patients in the buprenorphine group were engaged in addiction treatment at 2 months [68/92 (74%), 95% CI 65-83] compared with referral [42/79 (53%), 95% CI 42-64] and brief intervention [39/83 (47%), 95% CI 37-58; p < 0.001]. The differences were not significant at 6 months [51/92 (55%), 95% CI 45-65; 46/70 (66%) 95% CI 54-76; 43/76 (57%) 95% CI 45-67; p = 0.37] or 12 months [42/86 (49%) 95% CI 39-59; 37/73 (51%) 95% CI 39-62; 49/78 (63%) 95% CI 52-73; p = 0.16]. At 2 months, the buprenorphine group reported fewer days of illicit opioid use [1.1 (95% CI 0.6-1.6)] versus referral [1.8 (95% CI 1.2-2.3)] and brief intervention [2.0 (95% CI 1.5-2.6), p = 0.04]. No significant differences in illicit opioid use were observed at 6 or 12 months. There were no significant differences in HIV risk or rates of opioid-negative urine results at any time. CONCLUSIONS: ED-initiated buprenorphine was associated with increased engagement in addiction treatment and reduced illicit opioid use during the 2-month interval when buprenorphine was continued in primary care. Outcomes at 6 and 12 months were comparable across all groups.

An interventionist adherence scale for a specialized brief negotiation interview focused on treatment engagement for opioid use disorders.

BACKGROUND: No psychometrically validated instrument for evaluating the extent to which interventionists correctly implement brief interventions designed to motivate treatment engagement for opioid use disorders has been reported in the literature. The objective of this study was to develop and examine the psychometric properties of the Brief Negotiation Interview (BNI) Adherence Scale for Opioid Use Disorders (BAS-O). METHODS: In the context of a randomized controlled trial evaluating the efficacy of 3 models of emergency department care for opioid use disorders, the authors developed and subsequently examined the psychometric properties of the BAS-O, a 38-item scale that required raters to answer whether or not ("Yes" or "No") each of the critical actions of the BNI was correctly implemented by the research interventionist. BAS-O items pertained to the BNI's 4 steps: (1) Raise the Subject, (2) Provide Feedback, (3) Enhance Motivation, and (4) Negotiate and Advise. A total of 215 audio-recorded BNI and 88 control encounters were rated by 3 trained raters who were independent of the study team and blind to study hypotheses, treatment, and assignment. RESULTS: The results indicated the BAS-O has fair to excellent psychometric properties, in terms of good internal consistency, excellent interrater reliability, discriminant validity, and construct validity, and fair predictive validity. A 13-item, 2-factor solution accounted for nearly 80% of the variance, where factor 1 addressed "Autonomy and Planning" (7 items) and factor 2 addressed "Motivation and Problems" (6 items). However, predictive validity was found for only one of the BAS-O factor items (i.e., Telling patients that treatment will address a range of issues related to their opioid use disorder). CONCLUSIONS: This study suggests that the BAS-O is a psychometrically valid measure of adherence to the specialized BNI for motivating treatment engagement in patients with opioid use disorders, thus providing a brief (13-item), objective method of evaluating BNI skill performance.

Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial.

STUDY OBJECTIVE: Tobacco use is common among emergency department (ED) patients, many of whom have low income. Our objective is to study the efficacy of an intervention incorporating motivational interviewing, nicotine replacement, and quitline referral for adult smokers in an ED. METHODS: This was a 2-arm randomized clinical trial conducted from October 2010 to December 2012 in a northeastern urban US ED with 90,000 visits per year. Eligible subjects were aged 18 years or older, smoked, and were self-pay or had Medicaid insurance. Intervention subjects received a motivational interview by a trained research assistant, 6 weeks' worth of nicotine patches and gum initiated in the ED, a faxed referral to the state smokers' quitline, a booster call, and a brochure. Control subjects received the brochure, which provided quitline information. The primary outcome was biochemically confirmed tobacco abstinence at 3 months. Secondary endpoints included quitline use. RESULTS: Of 778 enrolled subjects, 774 (99.5%) were alive at 3 months. The prevalence of biochemically confirmed abstinence was 12.2% (47/386) in the intervention arm versus 4.9% (19/388) in the control arm, for a difference in quit rates of 7.3% (95% confidence interval 3.2% to 11.5%). In multivariable logistic modeling controlling for age, sex, and race or ethnicity, study subjects remained more likely to be abstinent than controls (odds ratio 2.72; 95% confidence interval 1.55 to 4.75). CONCLUSION: An intensive intervention improved tobacco abstinence rates in low-income ED smokers. Because approximately 20 million smokers, many of whom have low income, visit US EDs annually, these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers.

Inhaled corticosteroid beliefs, complementary and alternative medicine, and uncontrolled asthma in urban minority adults.

BACKGROUND: Many factors contribute to uncontrolled asthma; negative inhaled corticosteroid (ICS) beliefs and complementary and alternative medicine (CAM) endorsement are 2 that are more prevalent in black compared with white adults. OBJECTIVES: This mixed-methods study (1) developed and psychometrically tested a brief self-administered tool with low literacy demands to identify negative ICS beliefs and CAM endorsement and (2) evaluated the clinical utility of the tool as a communication prompt in primary care. METHODS: Comprehensive literature reviews and content experts identified candidate items for our instrument that were distributed to 304 subjects for psychometric testing. In the second phase content analysis of 33 audio-recorded primary care visits provided a preliminary evaluation of the instrument's clinical utility. RESULTS: Psychometric testing of the instrument identified 17 items representing ICS beliefs (α = .59) and CAM endorsement (α = .68). Test-retest analysis demonstrated a high level of reliability (intraclass correlation coefficient = 0.77 for CAM items and 0.79 for ICS items). We found high rates of CAM endorsement (93%), negative ICS beliefs (68%), and uncontrolled asthma (69%). CAM endorsement was significantly associated with uncontrolled asthma (P = .04). Qualitative data analysis provided preliminary evidence for the instrument's clinical utility in that knowledge of ICS beliefs and CAM endorsement prompted providers to initiate discussions with patients. CONCLUSION: Negative ICS beliefs and CAM endorsement were common and associated with uncontrolled asthma. A brief self-administered instrument that identifies beliefs and behaviors that likely undermine ICS adherence might be a leveraging tool to change the content of communications during clinic visits.

Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial.

IMPORTANCE: Opioid-dependent patients often use the emergency department (ED) for medical care. OBJECTIVE: To test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine). DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013. INTERVENTIONS: After screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group. MAIN OUTCOMES AND MEASURES: Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes. RESULTS: Seventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P < .001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P < .001 for both time and intervention effects; P = .02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P = .17). There were no statistically significant differences in HIV risk across groups (P = .66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P < .001). CONCLUSIONS AND RELEVANCE: Among opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00913770.

Predictors and moderators of aftercare appointment-keeping following brief motivational interviewing among patients with psychiatric disorders or dual diagnosis.

OBJECTIVE: Non-adherence to psychiatric and substance abuse treatment recommendations, especially with regard to aftercare outpatient appointment-keeping following hospitalizations, exacts a high cost on mental health spending and prevents patients from receiving therapeutic doses of treatment. Our primary objective was to evaluate the relationship between potential predictors and moderators of aftercare appointment-keeping among a group of adult patients immediately following hospitalization for severe psychiatric disorders or dual diagnosis. METHODS: Candidate predictors and moderator variables included demographics, psychiatric status, psychiatric symptom severity, and inpatient group adherence, while aftercare appointment-keeping was defined as attendance at the first aftercare appointment. Participants were 121 adult inpatients with a psychiatric disorder or dual diagnosis originally enrolled in an earlier randomized controlled trial comparing standard treatment with standard treatment plus brief motivational interviewing for increasing adherence. RESULTS: RESULTS indicated that, across treatment conditions, those who were female, did not have dual diagnosis, were older (older than 33 years), and were less educated (

Screening for problematic opioid use in the emergency department: Comparison of two screening measures.

Study objective: Earlier intervention for opioid use disorder (OUD) may reduce long-term health implications. Emergency departments (EDs) in the United States treat millions with OUD annually who may not seek care elsewhere. Our objectives were (1) to compare two screening measures for OUD characterization in the ED and (2) to determine the proportion of ED patients screening positive for OUD and those who endorse other substance use to guide future screening programs. Methods: A cross-sectional study of randomly selected adult patients presenting to three Midwestern US EDs were enrolled, with duplicate patients excluded. Surveys were administered via research assistant and documented on tablet devices. Demographics were self-reported, and OUD positivity was assessed by the DSM 5 checklist and the WHO ASSIST 3.1. The primary outcome was the concordance between two screening measures for OUD. Our secondary outcome was the proportion of ED patients meeting OUD criteria and endorsed co-occurring substance use disorder (SUD) criteria. Results: We enrolled 1305 participants; median age of participants was 46 years (range 18-84), with 639 (49.0%) Non-Hispanic, White, and 693 (53.1%) female. Current OUD positivity was identified in 17% (222 out of 1305) of the participants via either DSM-5 (two or more criteria) or ASSIST (score of 4 or greater). We found moderate agreement between the measures (kappa = 0.56; Phi coefficient = 0.57). Of individuals screening positive for OUD, 182 (82%) endorsed criteria for co-occurring SUD. Conclusions: OUD is remarkably prevalent in ED populations, with one in six ED patients screening positive. We found a high prevalence of persons identified with OUD and co-occurring SUD, with moderate agreement between measures. Developing and implementing clinically feasible OUD screening in the ED is essential to enable intervention.

Cost-Effectiveness of Smoking Cessation Approaches in Emergency Departments.

INTRODUCTION: Americans of lower SES use tobacco products at disproportionately high rates and are over-represented as patients of emergency departments. Accordingly, emergency department visits are an ideal time to initiate tobacco treatment and aftercare for this vulnerable and understudied population. This research estimates the costs per quit of emergency department smoking-cessation interventions and compares them with those of other approaches. METHODS: Previously published research described the effectiveness of 2 multicomponent smoking cessation interventions, including brief negotiated interviewing, nicotine replacement therapy, quitline referral, and follow-up communication. Study 1 (collected in 2010-2012) only analyzed the combined interventions. Study 2 (collected in 2017-2019) analyzed the intervention components independently. Costs per participant and per quit were estimated separately, under distinct intervention with dedicated staff and intervention with repurposed staff assumptions. The distinction concerns whether the intervention used dedicated staff for delivery or whether time from existing staff was repurposed for intervention if available. RESULTS: Data were analyzed in 2021-2022. In the first study, the cost per participant was $860 (2018 dollars), and the cost per quit was $11,814 (95% CI=$7,641, $25,423) (dedicated) and $227 per participant and $3,121 per quit (95% CI=$1,910, $7,012) (repurposed). In Study 2, the combined effect of brief negotiated interviewing, nicotine replacement therapy, and quitline cost $808 per participant and $6,100 per quit (dedicated) (95% CI=$4,043, $12,274) and $221 per participant and $1,669 per quit (95% CI=$1,052, $3,531) (repurposed). CONCLUSIONS: Costs varied considerably per method used but were comparable with those of other smoking cessation interventions.

Genetic Variants Associated With Opioid Use Disorder.

Genetics are presumed to contribute 30-40% to opioid use disorder (OUD), allowing for the possibility that genetic markers could be used to identify personal risk for developing OUD. We aimed to test the potential association among 180 candidate single nucleotide polymorphisms (SNPs), 120 of which were related to the dopamine reward pathway and 60 related to pharmacokinetics. Participants were randomly recruited in 2020-2021 in a cross-sectional genetic association study. Self-reported health history including Diagnostic and Statistical Manual of Mental Disorders (DSM-5) OUD criteria and buccal swabs were collected. A total of 1,301 participants were included in the analyses for this study. Of included participants, 250 met the DSM-5 criteria for ever having OUD. Logistic regression, adjusting for age and biologic sex, was used to characterize the association between each SNP and DSM-5 criteria consistent with OUD. Six SNPs found in four genes were associated with OUD: increased odds with CYP3A5 (rs15524 and rs776746) and DRD3 (rs324029 and rs2654754), and decreased odds with CYP3A4 (rs2740574) and CYP1A2 (rs2069514). Homozygotic CYP3A5 (rs15524 and rs776746) had the highest adjusted odds ratio of 2.812 (95% confidence interval (CI) 1.737, 4.798) and 2.495 (95% CI 1.670, 3.835), respectively. Variants within the dopamine reward and opioid metabolism pathways have significant positive (DRD3 and CYP3A5) and negative (CYP3A4 and CYP1A2) associations with OUD. Identification of these variants provides promising possibilities for genetic prognostic and therapeutic targets for future investigation.

Implementation Facilitation to Promote Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.

Importance: Emergency department (ED)-initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused. Objective: To evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy. Design, Setting, and Participants: This multisite hybrid type 3 effectiveness-implementation nonrandomized trial compared grand rounds with IF, with pre-post 12-month baseline and IF evaluation periods, at 4 academic EDs. The study was conducted from April 1, 2017, to November 30, 2020. Participants were ED and community clinicians treating patients with OUD and observational cohorts of ED patients with untreated OUD. Data were analyzed from July 16, 2021, to July 14, 2022. Exposure: A 60-minute in-person grand rounds was compared with IF, a multicomponent facilitation strategy that engaged local champions, developed protocols, and provided learning collaboratives and performance feedback. Main Outcomes and Measures: The primary outcomes were the rate of patients in the observational cohorts who received ED-initiated buprenorphine with referral for OUD treatment (primary implementation outcome) and the rate of patients engaged in OUD treatment at 30 days after enrollment (effectiveness outcome). Additional implementation outcomes included the numbers of ED clinicians with an X-waiver to prescribe buprenorphine and ED visits with buprenorphine administered or prescribed and naloxone dispensed or prescribed. Results: A total of 394 patients were enrolled during the baseline evaluation period and 362 patients were enrolled during the IF evaluation period across all sites, for a total of 756 patients (540 [71.4%] male; mean [SD] age, 39.3 [11.7] years), with 223 Black patients (29.5%) and 394 White patients (52.1%). The cohort included 420 patients (55.6%) who were unemployed, and 431 patients (57.0%) reported unstable housing. Two patients (0.5%) received ED-initiated buprenorphine during the baseline period, compared with 53 patients (14.6%) during the IF evaluation period (P < .001). Forty patients (10.2%) were engaged with OUD treatment during the baseline period, compared with 59 patients (16.3%) during the IF evaluation period (P = .01). Patients in the IF evaluation period who received ED-initiated buprenorphine were more likely to be in treatment at 30 days (19 of 53 patients [35.8%]) than those who did not 40 of 309 patients (12.9%; P < .001). Additionally, there were increases in the numbers of ED clinicians with an X-waiver (from 11 to 196 clinicians) and ED visits with provision of buprenorphine (from 259 to 1256 visits) and naloxone (from 535 to 1091 visits). Conclusions and Relevance: In this multicenter effectiveness-implementation nonrandomized trial, rates of ED-initiated buprenorphine and engagement in OUD treatment were higher in the IF period, especially among patients who received ED-initiated buprenorphine. Trial Registration: ClinicalTrials.gov Identifier: NCT03023930.

A brief intervention reduces hazardous and harmful drinking in emergency department patients.

STUDY OBJECTIVE: Brief interventions have been shown to reduce alcohol use and improve outcomes in hazardous and harmful drinkers, but evidence to support their use in emergency department (ED) patients is limited. The use of research assessments in studies of brief interventions may contribute to uncertainty about their effectiveness. Therefore we seek to determine (1) if an emergency practitioner-performed Brief Negotiation Interview or a Brief Negotiation Interview with a booster reduces alcohol consumption compared with standard care; and (2) the impact of research assessments on drinking outcomes using a standard care-no-assessment group. METHODS: We randomized 889 adult ED patients with hazardous and harmful drinking. A total of 740 received an emergency practitioner-performed Brief Negotiation Interview (n=297), a Brief Negotiation Interview with a 1-month follow-up telephone booster (Brief Negotiation Interview with booster) (n=295), or standard care (n=148). We also included a standard care with no assessments (n=149) group to examine the effect of assessments on drinking outcomes. Primary outcomes analyzed with mixed-models procedures included past 7-day alcohol consumption and 28-day binge episodes at 6 and 12 months, collected by interactive voice response. Secondary outcomes included negative health behaviors and consequences collected by telephone surveys. RESULTS: The reduction in mean number of drinks in the past 7 days from baseline to 6 and 12 months was significantly greater in the Brief Negotiation Interview with booster (from 20.4 [95% confidence interval {CI} 18.8 to 22.0] to 11.6 [95% CI 9.7 to 13.5] to 13.0 [95% CI 10.5 to 15.5]) and Brief Negotiation Interview (from 19.8 [95% CI 18.3 to 21.4] to 12.7 [95% CI 10.8 to 14.6] to 14.3 [95% CI 11.9 to 16.8]) than in standard care (from 20.9 [95% CI 18.7 to 23.2] to 14.2 [95% CI 11.2 to 17.1] to 17.6 [95% CI 14.1 to 21.2]). The reduction in 28-day binge episodes was also greater in the Brief Negotiation Interview with booster (from 7.5 [95% CI 6.8 to 8.2] to 4.4 [95% CI 3.6 to 5.2] to 4.7 [95% CI 3.9 to 5.6]) and Brief Negotiation Interview (from 7.2 [95% CI 6.5 to 7.9] to 4.8 [95% CI 4.0 to 5.6] to 5.1 [95% CI 4.2 to 5.9]) than in standard care (from 7.2 [95% CI 6.2 to 8.2] to 5.7 [95% CI 4.5 to 6.9] to 5.8 [95% CI 4.6 to 7.0]). The Brief Negotiation Interview with booster offered no significant benefit over the Brief Negotiation Interview alone. There were no differences in drinking outcomes between the standard care and standard care-no assessment groups. The reductions in rates of driving after drinking more than 3 drinks from baseline to 12 months were greater in the Brief Negotiation Interview (38% to 29%) and Brief Negotiation Interview with booster (39% to 31%) groups than in the standard care group (43% to 42%). CONCLUSION: Emergency practitioner-performed brief interventions can reduce alcohol consumption and episodes of driving after drinking in hazardous and harmful drinkers. These results support the use of brief interventions in ED settings.

Developing and implementing a multispecialty graduate medical education curriculum on Screening, Brief Intervention, and Referral to Treatment (SBIRT).

The authors sought to evaluate the feasibility and acceptability of initiating a Screening, Brief Intervention, and Referral to Treatment (SBIRT) for alcohol and other drug use curriculum across multiple residency programs. SBIRT project faculty in the internal medicine (traditional, primary care internal medicine, medicine/pediatrics), psychiatry, obstetrics and gynecology, emergency medicine, and pediatrics programs were trained in performing and teaching SBIRT. The SBIRT project faculty trained the residents in their respective disciplines, accommodating discipline-specific implementation issues and developed a SBIRT training Web site. Post-training, residents were observed performing SBIRT with a standardized patient. Measurements included number of residents trained, performance of SBIRT in clinical practice, and training satisfaction. One hundred and ninety-nine residents were trained in SBIRT: 98 internal medicine, 35 psychiatry, 18 obstetrics and gynecology, 21 emergency medicine, and 27 pediatrics residents. To date, 338 self-reported SBIRT clinical encounters have occurred. Of the 196 satisfaction surveys completed, the mean satisfaction score for the training was 1.60 (1 = very satisfied to 5 = very dissatisfied). Standardized patient sessions with SBIRT project faculty supervision were the most positive aspect of the training and length of training was a noted weakness. Implementation of a graduate medical education SBIRT curriculum in a multispecialty format is feasible and acceptable. Future efforts focusing on evaluation of resident SBIRT performance and sustainability of SBIRT are needed.

Perspectives About Emergency Department Care Encounters Among Adults With Opioid Use Disorder.

Importance: Emergency departments (EDs) are increasingly initiating treatment for patients with untreated opioid use disorder (OUD) and linking them to ongoing addiction care. To our knowledge, patient perspectives related to their ED visit have not been characterized and may influence their access to and interest in OUD treatment. Objective: To assess the experiences and perspectives regarding ED-initiated health care and OUD treatment among US patients with untreated OUD seen in the ED. Design, Setting, and Participants: This qualitative study, conducted as part of 2 studies (Project ED Health and ED-CONNECT), included individuals with untreated OUD who were recruited during an ED visit in EDs at 4 urban academic centers, 1 public safety net hospital, and 1 rural critical access hospital in 5 disparate US regions. Focus groups were conducted between June 2018 and January 2019. Main Outcomes and Measures: Data collection and thematic analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework with evidence (perspectives on ED care), context (ED), and facilitation (what is needed to promote change) elements. Results: A total of 31 individuals (mean [SD] age, 43.4 [11.0] years) participated in 6 focus groups. Twenty participants (64.5%) identified as male and most 13 (41.9%) as White; 17 (54.8%) reported being unemployed. Themes related to evidence included patients' experience of stigma and perceived minimization of their pain and medical problems by ED staff. Themes about context included the ED not being seen as a source of OUD treatment initiation and patient readiness to initiate treatment being multifaceted, time sensitive, and related to internal and external patient factors. Themes related to facilitation of improved care of patients with OUD seen in the ED included a need for on-demand treatment and ED staff training. Conclusions and Relevance: In this qualitative study, patients with OUD reported feeling stigmatized and minimized when accessing care in the ED and identified several opportunities to improve care. The findings suggest that strategies to address stigma, acknowledge and treat pain, and provide ED staff training should be implemented to improve ED care for patients with OUD and enhance access to life-saving treatment.

Development and usability evaluation of VOICES: A digital health tool to identify elder mistreatment.

BACKGROUND/OBJECTIVES: A major barrier for society in overcoming elder mistreatment is an inability to accurately identify victims. There are several barriers to self-reporting elder mistreatment, including fear of nursing home placement or losing autonomy or a caregiver. Existing strategies to identify elder mistreatment neglect to empower those who experience it with tools for self-reporting. In this project, we developed and evaluated the usability of VOICES, a self-administrated digital health tool that screens, educates, and motivates older adults to self-report elder mistreatment. DESIGN: Cross-sectional study with User-Centered Design (UCD) approach. SETTING: Yale School of Medicine and the Agency on Aging of South-Central Connecticut. PARTICIPANTS: Thirty eight community-dwelling and cognitively intact older adults aged 60 years and older, caregivers, clinicians, and social workers. INTERVENTION: A tablet-based self-administrated digital health tool that screens, educates, and motivates older adults to self-report elder mistreatment. MEASUREMENTS: Qualitative and quantitative data were obtained from: (1) focus groups participants including: feedback from open-ended discussion, demographics, and a post-session survey; (2) usability evaluation including: demographics, usability measures, comfortability with technology, emotional state, and open-ended feedback. RESULTS: Focus group participants (n = 24) generally favored using a tablet-based tool to screen for elder mistreatment and expressed comfort answering questions on elder mistreatment using tablets. Usability evaluation participants (n = 14) overall scored VOICES a mean System Usability Scale (SUS) score of 86.6 (median = 88.8), higher than the benchmark SUS score of 68, indicating excellent ease of use. In addition, 93% stated that they would recommend the VOICES tool to others and 100% indicated understanding of VOICES' information and content. CONCLUSION: Our findings show that older adults are capable, willing, and comfortable with using the innovative and self-administrated digital tool for elder mistreatment screening. Our future plan is to conduct a feasibility study to evaluate the use of VOICES in identifying suspicion of mistreatment.

A Brief Negotiation Interview Adherence Scale for Smoking Cessation: A psychometric evaluation.

Practitioner adherence to the Brief Negotiation Interview (BNI) for high-risk alcohol consumption and opioid use disorder can be measured using the BNI Adherence Scale, for alcohol (BAS-A) and opioids (BAS-O), respectively. However, no psychometrically validated brief intervention adherence scale for smoking cessation has been reported in the literature. Our objective was to develop and examine the psychometric properties of a BAS for smoking cessation (BASS). In the context of a clinical trial of the BNI in an emergency department (ED)-which incorporates motivational interviewing (MI), feedback, and behavioral contracting-plus nicotine replacement therapy (NRT), and a Smokers' Quitline referral and brochure (BNI), compared with brochure-only (control), we developed and examined the psychometric properties of the BAS-S, a scale that requires raters to answer whether each critical action of the BNI was implemented. Three independent raters rated three hundred and eighty-eight audio-recorded BNI sessions. The results indicated that the BAS-S had excellent internal consistency, and discriminant validity, inter-rater reliability, and construct validity. The following 3-factor (10-item) solution accounted for 43% of the variance: factor 1, "Feedback,", factor 2, "NRT Motivation," and factor 3, "Plan Negotiation." The study found predictive validity for the Feedback factor, suggesting that patients who were provided feedback on the harms of their smoking were significantly less likely to achieve biologically confirmed 7-day tobacco abstinence at their 3-month follow-up than those who were not provided such feedback (p < 0.03). The BAS-S is a psychometrically valid measure of adherence to the BNI for smoking cessation.

The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation.

ED-INNOVATION (Emergency Department-INitiated bupreNOrphine VAlidaTION) is a Hybrid Type-1 Implementation-Effectiveness multisite emergency department (ED) study funded through The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM efforts to increase access to medications for opioid use disorder (OUD). We use components of Implementation Facilitation to enhance adoption of ED-initiated buprenorphine (BUP) at approximately 30 sites. Subsequently we compare the effectiveness of two BUP formulations, sublingual (SL-BUP) and 7-day extended-release injectable (CAM2038, XR-BUP) in a randomized clinical trial (RCT) of approximately 2000 patients with OUD on the primary outcome of engagement in formal addiction treatment at 7 days. Secondary outcomes assessed at 7 and 30 days include self-reported opioid use, craving and satisfaction, health service utilization, overdose events, and engagement in formal addiction treatment (30 days) and receipt of medications for OUD (at 7 and 30 days). A sample size of 1000 per group provides 90% power at the 2-sided significance level to detect a difference in the primary outcome of 8% and accommodates a 15% dropout rate. We will compare the cost effectiveness of the two treatments on the primary outcome using the incremental cost-effectiveness ratio. We will also conduct an ancillary study in approximately 75 patients experiencing minimal to no opioid withdrawal who will undergo XR-BUP initiation. If the ancillary study demonstrates safety, we will expand the eligibility criteria for the RCT to include individuals with minimal to no opioid withdrawal. The results of these studies will inform implementation of ED-initiated BUP in diverse EDs which has the potential to improve treatment access.