Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial

Todd Molfenter, Hannah K Knudsen, Randy Brown, Nora Jacobson, Julie Horst, Mark Van Etten, Jee-Seon Kim, Eric Haram, Elizabeth Collier, Sanford Starr, Alexander Toy, Lynn Madden, Todd Molfenter, Hannah K Knudsen, Randy Brown, Nora Jacobson, Julie Horst, Mark Van Etten, Jee-Seon Kim, Eric Haram, Elizabeth Collier, Sanford Starr, Alexander Toy, Lynn Madden

Abstract

Background: Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the USA. Buprenorphine and extended-release naltrexone are key evidence-based pharmacotherapies available to addiction treatment providers to address opioid use disorder (OUD) and prevent overdose deaths. Treatment organizations' efforts to provide these pharmacotherapies have, however, been stymied by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe these medications. Historically, the addiction treatment field has not attracted physicians, and many barriers to implementing OUD pharmacotherapy exist, ranging from lack of confidence in treating OUD patients to concerns regarding reimbursement. Throughout the USA, the prevalence of OUD far exceeds the capacity of the OUD pharmacotherapy treatment system. Poor access to OUD pharmacotherapy prescribers has become a workforce development need for the addiction treatment field and a significant health issue.

Methods: This cluster randomized controlled trial (RCT) is designed to increase buprenorphine and extended-release naltrexone treatment capacity for OUD. The implementation intervention to be tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB), which was developed and piloted in a previous statewide buprenorphine implementation study. For this cluster RCT, organizational sites will be recruited and then randomized into one of two arms: (1) control, with treatment as usual and access to a website with PRB resources, or (2) intervention, with organizations implementing the PRB using the Network for the Improvement of Addiction Treatment organizational change model over a 24-month intervention period and a 10-month sustainability period. The primary treatment outcomes for each organizational site are self-reported monthly counts of buprenorphine slots, extended-release naltrexone capacity, number of buprenorphine patients, and number of extended-release naltrexone patients. This trial will be conducted in Florida, Ohio, and Wisconsin, resulting in 35 sites in each arm, for a total sample size of 70 organizations.

Discussion: This study addresses three issues of substantial public health significance: (1) the pressing opioid misuse epidemic, (2) the low uptake of OUD treatment pharmacotherapies, and (3) the need to increase prescriber participation in the addiction treatment workforce.

Trial registration: ClinicalTrials.gov NCT02926482.

Keywords: Addiction treatment; Buprenorphine; Evidence-based practice implementation; Medication-Assisted Treatment; Naltrexone.

Conflict of interest statement

Ethics approval and consent to participate

The described study was approved by the University of Wisconsin’s Health Sciences Institutional Review Board.

Consent for publication

Not applicable

Competing interests

The NIATx organizational change model was developed by the Center for Health Enhancement System Studies (CHESS) at the University of Wisconsin-Madison. Todd Molfenter, Ph.D., is a faculty member at the CHESS Center. Also, Dr. Molfenter is affiliated with the NIATx Foundation, the organization responsible for making the NIATx organizational change model to address access to and retention in behavioral health services available to the public. Dr. Molfenter has worked extensively with his institution to manage any conflicts of interest, and the NIATx Foundation will have no role in this study. The other authors declare that they have no competing interests.

Publisher’s Note

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

Figures

Fig. 1
Fig. 1
Consort diagram. PRB Prescriber Recruitment Bundle
Fig. 2
Fig. 2
PRB implementation sequence (during the 24-month intervention period). OUD opioid use disorders, PRB Prescriber Recruitment Bundle, MAT Medication-Assisted Therapy

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