Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

• ClinicalTrials.gov Identifier: NCT02926482
• Recruitment Status: Active, not recruiting
• First Posted: October 6, 2016
• Last Update Posted: November 28, 2018
• Sponsor: University of Wisconsin, Madison
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder	Behavioral: Prescriber Recruitment Bundle (PRB)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
• Study Start Date: April 2016
• Estimated Primary Completion Date: April 2020
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; This arm will include 35 organizations who receive access to the Prescriber Recruitment Bundle (PRB) materials online via a secure website.
Experimental: PRB: organizations implementing the PRB; This arm will include 35 organizations that will implement the intervention, the Prescriber Recruitment Bundle (PRB) using the NIATx Organizational Change Model (a model developed by our center research team).	Behavioral: Prescriber Recruitment Bundle (PRB); The Prescriber Recruitment Bundle (PRB) is a bundle pharmacotherapy capacity building practices. The PRB to be implemented contains 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, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.; Other Name: PRB

Outcome Measures

Primary Outcome Measures :

1. Buprenorphine slots and extended naltrexone capacity survey [ Time Frame: Monthly; beginning in Month 13 (April 2017 2016) and continuing up to Month 50. ]
   Monthly number of assigned and open buprenorphine slots as well as extended-release naltrexone capacity and administrations over the past month.

Secondary Outcome Measures :

1. Organizational survey [ Time Frame: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38. ]
   Measures PRB implementation fidelity
2. Physician Satisfaction [ Time Frame: Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38. ]
   Collected via the "Physician Worklife Survey." Quantitative measure of a physician (or other prescribers) job satisfaction.
3. Qualitative surveys [ Time Frame: Twice; first in Month 22 (January 2018) and again in Month 43. ]
   Measure of a addiction treatment organization's resources dedicated to prescriber recruitment. Participants will read statements regarding their organization's resources dedicated to prescriber recruitment, and their responses are recorded on a scale of 1-5, where 1 corresponds to "Not True" or "Strongly Disagree" and 5 corresponds to "Very True" or "Strongly Agree."

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Florida Alcohol and Drug Abuse Association

Tallahassee, Florida, United States, 32308

United States, Ohio

Ohio Department of Mental Health and Addiction Services

Columbus, Ohio, United States, 43215-3430

United States, Wisconsin

Center for Health Enhancement Systems

Madison, Wisconsin, United States, 53706

Sponsors and Collaborators

University of Wisconsin, Madison

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Todd Molfenter; Center for Health Enhancement Systems Studies, University of Wisconsin-Madison

More Information

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Molfenter T, Kim JS, Quanbeck A, Patel-Porter T, Starr S, McCarty D. Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial. Implement Sci. 2013 May 10;8:50. doi: 10.1186/1748-5908-8-50.

Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine Prescribing Availability in a Sample of Ohio Specialty Treatment Organizations. J Addict Behav Ther Rehabil. 2015;4(2). pii: 1000140.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Knudsen HK, Brown R, Jacobson N, Horst J, Kim JS, Collier E, Starr S, Madden LM, Haram E, Toy A, Molfenter T. Physicians' satisfaction with providing buprenorphine treatment. Addict Sci Clin Pract. 2019 Aug 26;14(1):34. doi: 10.1186/s13722-019-0163-3.

Molfenter T, Knudsen HK, Brown R, Jacobson N, Horst J, Van Etten M, Kim JS, Haram E, Collier E, Starr S, Toy A, Madden L. Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial. Implement Sci. 2017 Nov 15;12(1):135. doi: 10.1186/s13012-017-0665-x.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT02926482 History of Changes
• Other Study ID Numbers: 2016-0486; 1R01DA041415 ( U.S. NIH Grant/Contract )
• First Posted: October 6, 2016
• Last Update Posted: November 28, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:

Evidence-based practice implementation; Buprenorphine; Addiction treatment; Extended-release naltrexone; Addiction

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Buprenorphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists