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Abstract: Background: Adoption of ED-initiated buprenorphine for opioid use disorder has been slow despite evidence of its effectiveness. Implementation facilitation (IF) is an evidence-based implementation strategy to promote adoption of new practices within clinical settings. The Clinical Trials Network (CTN)-0069 Project ED Health” study evaluated whether provision of ED-initiated buprenorphine with referral for community-based medication for opioid use disorder (MOUD) increased after IF. We identified the health system resources required to conduct IF and sustain ED-initiated buprenorphine with referral for community-based MOUD and then calculated the financial costs associated with using those resources. Methods: We estimated costs using nationally representative employee values of the formative evaluation and other IF-related resources (e.g., focus groups, clinician education, and academic detailing), using microcosting analysis to capture quantitative data and assign nationally-representative costs based on Drug Abuse Treatment Cost Analysis Program (DATCAP). The study data was collected from 2017 to 2020 from four sites. We calculated costs per site for three distinct phases: pre-implementation, IF, and sustainment. Results: The mean, per-site, costs were: pre-implementation = $27,753 (range: $25,859$27,821), IF = $53,558 (range: $48,417-$59,468) and annual sustainment = $226,822(range: $104,871-$339,100), which resulted in a mean per-patient cost of $115 assuming an average of 195 patients identified with untreated OUD, per-month, across sites. Conclusions: The microcosting analysis revealed the resources and costs involved in implementing ED-initiated buprenorphine programs at various sites. Understanding the different ways each site customized the IF strategy can improve adoption to this initiative. Interpreting the costs during the intervention and what it takes to sustain it will help decision makers address uncertainty and promote increased acceptance of implementing these practices in the context of potential benefits that this approach can provide. Related protocols: CTN-0069

Abstract:

Background: The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has supported clinical trials of substance use disorder (SUD) interventions for 25 years. This review describes the use of implementation outcomes across CTN trials, characterizes outcomes included, and identifies gaps and potential opportunities to strengthen implementation research within the CTN and the field of SUD treatment.

Methods: This systematic review included active or completed studies listed on the CTN Dissemination Library webpage as of August 18, 2021, and approved by the CTN for development by January 1, 2022. Study summaries and protocols were reviewed if they: 1) measured at least one implementation outcome and 2) examined a practice change, intervention, or process. Extracted data elements included trial design characteristics, implementation frameworks, and outcome assessment domains informed by the RE-AIM and Proctor Implementation Outcomes Frameworks.

Results: 114 protocols were considered, 42 full-text protocols were screened, and 25 were included for data extraction. Start dates of trials spanned a 20-year period (2004–2024) with latter studies including more implementation outcomes. Fidelity (n = 29) and reach/penetration (n = 26) were the most included implementation outcomes. Equity was not identified in any protocols. Methods of defining, capturing, and evaluating outcomes data varied across trials and outcomes.

Conclusions: The inclusion of implementation outcomes increased over time, perhaps reflecting a growing emphasis on implementation research. Incorporating measures of equity could advance knowledge about differential receipt or effectiveness of SUD interventions. Future research should seek to improve the consistency and comprehensiveness in descriptions of implementation science elements.

Related protocols: CTN-0016, CTN-0056, CTN-0062-Ot, CTN-0064, CTN-0065, CTN-0069, CTN-0074, CTN-0074-A-1, CTN-0075, CTN-0076-Ot, CTN-0079, CTN-0079-A-1, CTN-0088, CTN-0090, CTN-0091, CTN-0095, CTN-0096, CTN-0097, CTN-0098, CTN-0099, CTN-0102, CTN-0103, CTN-0107, CTN-0116, CTN-0121

Abstract:

In this webinar for the CTN Translation & Implementation SIG, Gail D’Onofrio, MD, MS, and David A. Fiellin, MD, shared their study approach and results for CTN-0069: Opioid Use Disorder in the ED (Project ED Health), as well as considerations for integrating implementation outcome evaluations in efficacy/effectiveness protocols.

Abstract:

Study objective(s): To evaluate the cost-effectiveness of implementation facilitation compared with a standard educational strategy to promote emergency department (ED)-initiated buprenorphine with linkage to ongoing opioid use disorder care in the community, from a health care-sector perspective.

Methods: A prospective cost-effectiveness analysis was conducted alongside “Project ED Health” (CTN-0069), a hybrid type 3 implementation-effectiveness study conducted at 4 academic EDs. Resources were gathered and valued according to the health care-sector perspective. Three effectiveness measures were evaluated: quality-adjusted life-years, opioid-free years, and patient engagement in community-based opioid use disorder care on the 30th day following the index ED visit. An incremental cost-effectiveness ratio was calculated for each measure of effectiveness. Likelihood of cost-effectiveness was evaluated across a wide range of “value” thresholds through cost-effectiveness acceptability curves.

Results: The mean, per-person, health care-sector cost associated with ED-administered buprenorphine following implementation facilitation did not differ significantly from that of standard education ($3,239 versus $4,904), whereas the mean effectiveness for all 3 measures significantly favored the implementation facilitation strategy. Implementation facilitation has a 74% to 75% probability of being considered cost-effective from a health care-sector perspective at the recommended value range of $100,000 to $200,000 per quality-adjusted life-year. Incremental cost-effectiveness ratios estimated using secondary effectiveness measures had a 75% probability of being considered cost-effective at $25,000 per opioid-free year and $38,000 per engagement.

Conclusion: Implementation facilitation, relative to a standard educational strategy, has a moderate-to-high likelihood of being considered cost-effective from a health care-sector perspective, depending on decisionmakers’ willingness to pay for units of effectiveness.

Related protocols: CTN-0069

Abstract:

There has been a significant increase in methamphetamine use and methamphetamine use disorder (Meth UD) in the United States, with evolving racial and ethnic differences. This secondary analysis of data from CTN-0069 (ADAPT-2) explored racial and ethnic differences in baseline sociodemographic and clinical characteristics as well as treatment effects on a measure of substance use recovery, depression symptoms, and methamphetamine craving among participants in a pharmacotherapy trial for Meth UD.

The ADAPT-2 trial (ClinicalTrials.gov number, NCT03078075; N=403; 69% male) was a multisite, 12-week randomized, double-blind, trial that employed a two-stage sequential parallel design to evaluate the efficacy of combination naltrexone (NTX) and oral bupropion (BUP) vs. placebo for Meth UD. Treatment effect was calculated as the weighted mean change in outcomes in the NTX-BUP minus placebo group across the two stages of treatment.

Of the 403 participants in the ADAPT-2 trial, the majority (65%) reported non-Hispanic White, while 14%, 11% and 10% reported Hispanic, non-Hispanic Black, and non-Hispanic other racial and ethnic categories respectively. At baseline non-Hispanic Black participants reported less severe indicators of methamphetamine use than non-Hispanic White. Treatment effects for recovery, depression symptoms and methamphetamine cravings did not significantly differ by race and ethnicity.

Conclusions: Although we found racial and ethnic differences at baseline, our findings did not show racial and ethnic differences in treatment effects of NTX-BUP on recovery, depression symptoms and methamphetamine cravings. However, our findings also highlight the need to expand representation of racial and ethnic minority groups in future trials.

Related protocols: CTN-0068

Abstract:

An increasing number of emergency departments (EDs) are initiating buprenorphine for opioid use disorder (OUD) and linking patients to ongoing community-based treatment, yet community-based clinician and staff perspectives regarding this practice have not been characterized. This study aimed to explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions.

This qualitative study reports findings from Project ED Health (NIDA-CTN-0069), a hybrid type 3 effectiveness-implementation study designed to evaluate the impact of implementation facilitation on ED-initiated buprenorphine with referral to ongoing medication treatment. Clinicians and staff from community-based treatment programs were identified by urban academic EDs as potential referral sites for ongoing OUD treatment in 4 cities across the US in a formative evaluation as having the capability to continue medication treatment. Focus groups were held from April 1, 2018, to January 11, 2019, to examine community OUD treatment clinician and staff perspectives on accepting patients who have received ED-initiated buprenorphine. Data were analyzed from August 2020 to August 2022. Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework, focusing on domains including evidence, context, and facilitation.

A total of 103 individuals (mean [SD] age, 45.3 [12.0] years; 76 female and 64 White) participated in 14 focus groups (groups ranged from 3-22 participants). Participants shared negative attitudes toward buprenorphine and variable attitudes toward ED-initiated buprenorphine. Prominent barriers included the community site treatment capacity and structure as well as payment and regulatory barriers. Perceived factors that could facilitate this model included additional substance use disorder training for ED staff, referrals and communication, greater inclusion of peer navigators, and addressing sociostructural marginalization that patients faced.

Conclusions: In this study of community-based clinicians and staff positioned to deliver OUD treatment, participants reported many barriers to successful linkages for patients who received ED-initiated buprenorphine. Strategies to improve these linkages included educating communities and programs, modeling low-barrier philosophies, and using additional staff trained in addiction as resources to improve transitions from EDs to community partners.

Related protocols: CTN-0069

Abstract:

There has been a substantial rise in the number of publications and training opportunities on the care and treatment of emergency department (ED) patients with opioid use disorder over the past several years. The American College of Emergency Physicians recently published recommendations for providing buprenorphine to patients with opioid use disorder, but barriers to implementing this clinical practice remain. This paper describes models for implementing ED-initiated buprenorphine at 4 diverse urban, academic medical centers across the country as part of a federally funded effort termed “Project ED Health” (protocol CTN-0069). These 4 sites successfully implemented unique ED-initiated buprenorphine programs as part of a comparison of implementation facilities to traditional educational dissemination on the uptake of ED-initiated buprenorphine. Each site describes the elements central to the ED process, including screening, treatment initiation, referral, and follow-up, while harnessing organizational characteristics, including ED culture. Finally, the paper discusses common facilitators to program success, including information technology and electronic medical record integration, hospital-level support, strong connections with outpatient partners, and quality improvement processes.

Related protocols: CTN-0069

Abstract:

For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. The prevailing culture of the ED has been that substance use disorders are non-emergent conditions better addressed outside the ED where resources are less constrained. This study, its rapid funding mechanism, and accelerated timeline originated out of the urgent need to learn whether ED-initiated buprenorphine (BUP) with referral for treatment of OUD is generalizable, as well as to develop strategies to facilitate its adoption across a variety of ED settings and under real-world conditions. It both complements and uses methods adapted from Project ED Health (CTN-0069), a hybrid type 3 implementation-effectiveness study of using Implementation Facilitation (IF) to integrate ED-initiated BUP and referral programs.

ED-CONNECT (CTN 0079) was a three-site implementation study exploring the feasibility, acceptability, and impact of introducing ED-initiated BUP in rural and urban settings with high-need, limited resources, and different staffing structures. Researchers used a multi-faceted approach to develop, introduce and iteratively refine site-specific ED clinical protocols and implementation plans for opioid use disorder (OUD) screening, ED-initiated BUP, and referral for treatment. They employed a participatory action research approach and use mixed methods incorporating data derived from abstraction of medical records and administrative data, assessments of recruited ED patient-participants, and both qualitative and quantitative inquiry involving staff from the ED and community, patients, and other stakeholders.

Discussion: This study was designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs previously not providing ED-initiated BUP, in communities in which this intervention is most needed: high need, low resource settings.

Related protocols: CTN-0069

Abstract:

Little is known regarding the sociodemographic and clinical characteristics of emergency department (ED) patients with untreated opioid use disorder (OUD) and the relationship of those characteristics with whether they were seeking a referral to substance use treatment at the time of their ED visit.

Using data collected from 2/2017 – 1/2019 from participants enrolled in CTN Project ED Health (CTN-0069), researchers conducted a cross-sectional analysis of patients with untreated moderate to severe OUD presenting to one of four EDs in Baltimore, New York City, Cincinnati, or Seattle. Sociodemographic and clinical correlates, and International Classification of Diseases Tenth Revision (ICD-10) diagnosis codes related to opioid withdrawal, injection-related infection, other substance use, overdose, and OUD of those seeking and not seeking a referral to substance use treatment on presentation were compared using univariate analyses.

Among 394 study participants, 15.2% came to the ED seeking a referral to substance use treatment. No differences in age, gender, education, health insurance status, or housing stability were detected between those seeking and not seeking referral to substance use treatment. Those seeking a referral were less likely to have urine toxicology testing positive for amphetamine (17% vs. 31%) and methamphetamine (23% vs. 40%), but more likely to test positive for cocaine (56.7% vs. 42.5%), fentanyl (65% vs. 48.8%), and morphine (93.3% vs. 81.4%), compared to those not seeking a referral.

Conclusions: Most patients with untreated OUD seen in the ED are not there to seek a referral to substance use treatment. Those seeking a referral were less likely to have a urine toxicology test positive for amphetamines/methamphetamines and to be white; they were more likely to have urine toxicology testing positive for cocaine, fentanyl, or morphine. Study findings also suggest a disparity between the presence of OUD and the incorporation of ICD diagnoses for OUD into the electronic medical record in ED patients. Active motivational enhancement, treatment initiation, and coding may improve ED efforts to address untreated OUT and expand access to effective medication for OUD treatment.

Related protocols: CTN-0069

Abstract:

Concurrent use of amphetamine-type stimulants among individuals with opioid use disorder can exacerbate social and medical harms, including overdose risk. This study evaluated rates of amphetamine-type stimulant use among patients with untreated opioid use disorder presenting at emergency departments in Baltimore, MD; New York, NY; Cincinnati, OH; and Seattle, WA.

Emergency department (ED) patients with untreated opioid use disorder (N=396) and enrolled between February 2017 and January 2019 in a multisite hybrid type III implementation science study (CTN-0069, Opioid Use Disorder in the Emergency Department) were evaluated for concurrent amphetamine-type stimulant use. Individuals with urine tests positive for methamphetamine, amphetamine, or both were compared with amphetamine-type stimulant-negative patients.

Overall, 38% of patients (150/396) were amphetamine-type stimulant positive; none reported receiving prescribed amphetamine or methamphetamine medications. Amphetamine-type stimulant-positive versus -negative patients were younger: mean age was 36 years versus 40 years. Other differences: 69% versus 46% were white, 65% versus 54% were unemployed, 67% versus 49% had unstable housing, 47% versus 25% reported an incarceration during 1 year before study admissions, 60% versus 45% were hepatitis C positive, 79% versus 47% reported drug injection during 1 month before study admission, and 42% versus 29% presented to the ED for an injury. Lower proportions of amphetamine-type stimulant-positive patients had cocaine-positive urine test results (33% versus 52%) and reported seeking treatment for substance use problems as a reason for their ED visit (10% versus 19%). All comparisons were statistically significant.

Conclusions: Amphetamine-type stimulant use among ED patients with untreated opioid use disorder was associated with distinct sociodemographic, social, and health factors. Improved ED-based screening, intervention, and referral protocols for patients with opioid use disorder and amphetamine-type stimulant use are needed.

Related protocols: CTN-0069