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Objectives: To identify and value resources required to implement and sustain the Massachusetts model of office-based addiction treatment (MA Model) in the Primary Care Opioid Use Disorders Treatment trial (NCT03407638) using a nurse care manager (NCM) to support medication for opioid use disorder in primary care settings.

Study design: A site-specific microcosting analysis was conducted via activity-based costing. Guided by a structured costing instrument, we conducted semistructured interviews with relevant personnel and assigned nationally representative costs.

Methods: Data came from 6 health care systems. Costs were categorized as fixed start-up, time dependent, or variable and estimated as annual per-clinic and per-patient costs for implementation and sustainment phases.

Results: Mean implementation cost (ie, year 1 fixed start-up, time-dependent, and variable) was $238,888 per clinic ($3185 per patient); each subsequent year cost $229,676 ($3062 per patient), assuming 75 patients per month and 29% new patient case mix. Mean onetime fixed start-up costs were $9212 per clinic and included supplies and training. Time-dependent costs were $70,446 per clinic and included rent and meetings. Variable costs were $159,229 per clinic and included NCMs’ and prescribers’ clinical duties. On average, NCMs spent 1967.6 hours on MA Model-related work per year (26.2 hours per patient). In sensitivity analyses, costs varied drastically with patient caseload, provider mix, and new patient case mix.

Conclusions: Fixed start-up and time-dependent costs were minimal. Variable costs were 66.7% of implementation costs and 69.3% of costs annually afterward. The primary cost driver was NCM time conducting MA Model-related work. The additional value of the model will depend on associated downstream outcomes. These results may be helpful to health care systems considering implementing the MA Model.

Related protocols: CTN-0074

Background: Stigma toward people with substance use disorders (SUD) remains a major barrier to care. There have been multiple calls to action to address SUD stigma in healthcare settings and other reviews have clarified the need for more rigorous effectiveness research. In addition to attention to effectiveness research, there is a need to attend to the implementation strategies used to deliver SUD stigma reduction interventions. Delineating discrete implementation strategies that have been used to address stigma will support future research efforts to arrive at the most optimal interventions to address SUD stigma.

Methods: We searched three databases and extracted data to identify interventions tested to reduce SUD stigma. We used the adapted Expert Recommendations for Implementing Change (ERIC) taxonomy to characterize the discrete implementation strategies used to support the adoption, implementation, sustainment, and scale-up (or spread) of each intervention.

Results: This scoping review synthesized 108 peer-reviewed studies reporting on interventions which to address SUD stigma among healthcare professionals. Most interventions were implemented in training environments, including higher education and continuing education settings, and focused on providing basic education on SUD broadly or opioid use disorder. Within interventions, educational and training implementation strategies were most prominent with 74% of studies using educational meetings and 39% distributing training materials. Far fewer studies used implementation strategies that used experiential approaches such interactive assistance, simulation, case-based learning, or contact with people with lived experience. Most studies (73%) reported reductions in stigmatizing attitudes, most often immediately post-intervention, though the need for higher study quality was notable.

Conclusions: Existing stigma-reduction interventions are overwhelmingly education-focused and primarily implemented in academic settings, with limited use of strategies that promote reflective learning, contact-based engagement, or organizational change. Future work should employ more rigorous designs that systematically test implementation strategies to create packaged SUD stigma reduction interventions optimized for effectiveness and implementation.

Importance: Hospital-based opioid treatment (HBOT) can improve outcomes for patients with opioid use disorder, but little is known about specific attributes and supports needed for clinical champions to successfully implement HBOT.

Objective: To identify characteristics and supports of effective clinical champions implementing HBOT in US hospitals.

Design, setting, and participants: Qualitative study using postimplementation semistructured interviews conducted with individuals highly involved in HBOT implementation, including champions and hospital staff at 12 US community hospitals randomized to the high-intensity group of the Exemplar Hospital Initiation Trial to Enhance Treatment Engagement, a national implementation trial comparing low- and high-intensity HBOT implementation strategies. Interviews explored implementation experiences over 24 months from December 2021 to December 2023. Interviews were audio recorded, transcribed, and coded. The framework method and in-depth thematic analysis were used to explore the role of champions.

Interventions: All hospitals received a best-practices manual, video webinar series, and hub team support for questions, while hospitals randomized to the high-intensity group also received monthly practice facilitation, telementoring, and 10% effort funding for a local champion. Champions led HBOT implementation with support from regional hubs with HBOT expertise.

Measures: Effective champions were defined as those perceived by staff to successfully lead HBOT implementation. Open-ended questions and thematic analysis explored participants’ perspectives on attributes of effective champions and how they overcame implementation barriers.

Results: A total of 31 hospital staff (15 physicians, 5 executives, 5 pharmacists, 2 nurse practitioners, 2 social workers, 1 nurse, and 1 addiction counselor) were interviewed. Effective champions were perceived as respected hospital “insiders” with institutional influence, persistence, and systems change skills. They built multidisciplinary teams, developed standard workflows, and used emotionally resonant strategies (eg, patient narratives) to overcome stigma and engage hospital leadership. Champions could be effective without addiction medicine expertise, particularly when provided with protected time, hospital leadership support, and external practice facilitation from addiction experts.

Conclusions and relevance: This multisite qualitative study underscores the vital role of champions in expanding hospital-based opioid care. To ensure HBOT expansion, hospitals should invest in champions, protected time, leadership backing, and external supports that legitimize and routinize evidence-based addiction care.

Related protocols: CTN-0098

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

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

In this session at the 2025 Quarterly CTN Steering Committee Meeting on March 11, 2025, presenters Mark McGovern, Joe Glass, and Sophia Gonzalez provided updates from the CTN T&I SIG, including:

• An overview of the history and purpose of the SIG
• Some background on the purpose of implementation science
• A description of the two T&I SIG workgroups: Implementation Strategies and Implementation Outcomes
• A detailed presentation on the results of a systematic review by the Implementations Outcomes workgroup on implementation outcomes included in NIDA CTN studies over 20 years of research.

In this webinar for the CTN Translation & Implementation SIG, Danny Almirall, a statistician and effectiveness implementation intervention scientist, discussed the need for multilevel, multicomponent implementation strategies from the perspective of implementation support professionals; and multilevel adaptive implementation strategies (MAISYs) as a potential solution. He also described 14 different types of scientific questions that an Optimization Implementation Scientist might ask about MAISYs, as well as how best to match these optimization scientific questions with the appropriate randomized trial design.

This presentation reviews the role of Community-Based Participatory Research (CBPR) principles and practices in the implementation of evidence-based and/or community-informed practices. It will include illustrations from current and recent studies of community engagement in identification of barriers and facilitators, co-design of implementation strategies, and conduct of formative evaluations of implementation process and outcomes using the RAPICE (Rapid Assessment Procedures-Informed Community Ethnography) methodology.

This presentation focuses on barriers faced by youth involved in the legal system to access treatment, ongoing efforts going across Indiana to improve training in evidence-based treatment, as well as implementation strategies to improve treatment.

This presentation discusses the field of human-centered design (HCD), its alignment with implementation science, and ways that HCD can be leveraged to advance the goals of contemporary implementation science, especially surrounding the strategic adaptation of complex psychosocial interventions and implementation strategies.

In this presentation, Dr. Curran discusses ways to integrate implementation-focused research concepts and questions into clinical trials. He will cover concepts and approaches such as “design for dissemination/implementation,” “implementability,” and effectiveness-implementation hybrid designs. He will share examples from his own work and from others who combine their efficacy/effectiveness and implementation research.

This presentation from Leopoldo J. Cabassa, PhD, MSW (Center for Mental Health Services Research, Brown School of Social work, Washington University) presents strategies and ways to infuse equity approaches into implementation science studies to proactively address healthcare inequities in historically marginalized populations.

This presentation describes a program of research focused on increasing the uptake of effective services for youth with or at risk of substance use disorders. The presentation introduces both patient-focused dissemination (e.g., technology-assisted interventions, direct-to-consumer marketing) and provider- and organization-focused (e.g., multi-level implementation strategy) strategies. Fundamentals of dissemination and implementation science, as well as priorities for future research, are also discussed.

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The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies.

This study aimed to summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting, CTN-0037, the Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) trial.

Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. The authors propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN.

Conclusions: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available.

Related protocols: CTN-0037

Patients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for medical conditions, their addiction, withdrawal symptoms, or complications from injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation change, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice.

This article describes a study that is being conducted through the NIDA Clinical Trials Network (CTN-0099). A hybrid type III effectiveness-implementation study design is being used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-minute “Grand Rounds” educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine, followed by a 1-year baseline evaluation period.

Using a modified stepped wedge design, sites are randomly assigned to the IF intervention, which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine.

During the 6 months of IF through the 1-year IF evaluation period, external facilitators will work with local stakeholders to tailor and refine a bundle of activities to meet the site’s needs. The primary analyses will compare the baseline evaluation period to the IF evaluation period (n=120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, researchers will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs.

Conclusions: The ED is rapidly being identified as a “24/7/365” site to combat the opioid crisis by offering access to medications for opioid use disorder treatment. Sustainable, evidence-based practice implementation is a complex and challenging process. This study has the potential to identify an implementation strategy that can be translated to other EDs, thereby increasing the adoption of ED-initiated buprenorphine into practice, narrowing the gap between OUD identification and treatment.

Related protocols: CTN-0099