Clinical trial NCT02926482: Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers
Official title: Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Evidence-based practice implementation
Buprenorphine
Addiction treatment
Extended-release naltrexone
Addiction
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-06
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a cluster-randomized controlled trial designed to increase the availability of buprenorphine and extended-release naltrexone treatment capacity for opioid use disorder (OUD). The intervention being tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB). For the study, 70 organizations will be identified and recruited, and those organizations will then be randomized into one of two arms: 1) control, and 2) intervention: organizations implementing the PRB using the Network for Improvement of Addiction Treatment (NIATx) Organizational Change Model. The primary research question is to test the impact of the PRB, relative to the control, on increasing buprenorphine treatment slots and extended-release naltrexone capacity and the number of patients receiving these pharmacotherapies.

Detailed description: Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the United States. Buprenorphine and extended-release naltrexone are key evidence-based interventions available to addiction treatment providers to treat opioid use disorder (OUD) and prevent overdose deaths. However, organizations' efforts to provide these pharmacotherapies have been hindered by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe the medications. The addiction field has not historically attracted physicians and limits on access are compounded by buprenorphine's unique regulatory situation, in which physicians and other prescribers must apply for a waiver that allows them buprenorphine prescribing slots to treat 30 patients in the first year and 100 in the following years.

This study will address this emerging need to increase access to buprenorphine and extended-release naltrexone by testing a bundle of practices, called the Prescriber Recruitment Bundle (PRB), which aims to recruit prescribers licensed to prescribe buprenorphine to work with addiction treatment organizations. The PRB consists of the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine to provide access to OUD pharmacotherapies, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.

In this cluster randomized controlled trial, the primary research question is to test the impact of the PRB implemented in conjunction with the NIATx organizational change model, relative to the control, on increasing the number of buprenorphine treatment slots and extended-release naltrexone capacity and increasing the number of patients receiving buprenorphine and extended-release naltrexone in the participating addiction treatment organizations. The secondary research question is to test if the PRB affects factors likely to be associated with prescriber recruitment, including: resources dedicated to prescriber recruitment, prescriber recruiter motivation, and current employed physician satisfaction. Lastly, qualitative methods will be used to study the context and processes that influence PRB adoption and fidelity and to understand and develop a deeper understanding of how the PRB influences recruitment beyond the existing study variables.

Eligibility criteria: Inclusion Criteria:

* Organizations that are publicly funded through the Substance Abuse and Prevention Treatment (SAPT) block grant, and had more than 100 admissions/annum about their interest in greater buprenorphine prescribing capacity.
* Organizations in the states of Florida, Ohio, and Wisconsin.

Exclusion Criteria:

* Organizations that are not publicly funded through the SAPT block grant, or do not have interest in expanding their buprenorphine prescribing capacity.

Primary outcomes:
measure: Buprenorphine slots and extended naltrexone capacity survey
timeFrame: Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.
Secondary outcomes:
measure: Organizational survey
timeFrame: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
measure: Physician Satisfaction
timeFrame: Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
measure: Qualitative surveys
timeFrame: Twice; first in Month 22 (January 2018) and again in Month 43.
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida Alcohol and Drug Abuse Association
state: Florida
city: Columbus
country: United States
facility: Ohio Department of Mental Health and Addiction Services
state: Ohio
city: Madison
country: United States
facility: Center for Health Enhancement Systems
state: Wisconsin
Study officials:
affiliation: Center for Health Enhancement Systems Studies, University of Wisconsin-Madison
name: Todd Molfenter
role: PRINCIPAL_INVESTIGATOR
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