Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH)

Gail D'Onofrio, E Jennifer Edelman, Kathryn F Hawk, Michael V Pantalon, Marek C Chawarski, Patricia H Owens, Shara H Martel, Paul VanVeldhuisen, Neal Oden, Sean M Murphy, Kristen Huntley, Patrick G O'Connor, David A Fiellin, Gail D'Onofrio, E Jennifer Edelman, Kathryn F Hawk, Michael V Pantalon, Marek C Chawarski, Patricia H Owens, Shara H Martel, Paul VanVeldhuisen, Neal Oden, Sean M Murphy, Kristen Huntley, Patrick G O'Connor, David A Fiellin

Abstract

Background: Patients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for general medical conditions, their addiction, withdrawal symptoms, or complications of 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 challenge, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice.

Methods: This protocol describes a study that is being conducted through the National Institute on Drug Abuse's Center for the Clinical Trials Network. A hybrid type III effectiveness-implementation study design is 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-min "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 work with local stakeholders to tailor and refine a bundle of activities to meet the site's needs. The primary analyses 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, we will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs.

Discussion: Results will generate novel information regarding the impact of IF as a strategy to promote ED-initiated buprenorphine.

Trial registration: ClinicalTrials.gov NCT03023930 first posted 1/10/2017, https://ichgcp.net/clinical-trials-registry/NCT03023930?term=0069&rank=1.

Keywords: Buprenorphine; Emergency service, hospital; Hybrid design; Implementation science; Opioid-related disorders.

Conflict of interest statement

Ethics approval and consent to participate

The protocol was approved by Western Institutional Review Board (WIRB) [PROTOCOL NUMBER: 20162913], and reliance agreements were obtained locally at each site. A waiver of informed consent was granted for ED and community provider surveys and focus groups. Written consent is obtained for all patient participants.

Consent for publication

Not applicable.

Competing interests

SM consulted with Sandoz Inc. on an unrelated project. Aetna provided funding for filming and production of videos displayed on our websites.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study activities overview
Fig. 2
Fig. 2
Timeline

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