Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

August 9, 2024 updated by: University of Wisconsin, Madison

Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Florida Alcohol and Drug Abuse Association
    • Ohio
      • Columbus, Ohio, United States, 43215-3430
        • Ohio Department of Mental Health and Addiction Services
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Center for Health Enhancement Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • PRB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buprenorphine slots and extended naltrexone capacity survey
Time Frame: Monthly; beginning in Month 13 (April 2017) 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.
Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organizational survey
Time Frame: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
Measures PRB implementation fidelity
Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
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.
Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
Qualitative surveys
Time Frame: Twice; first in Month 22 (January 2018) and again in Month 43.
Measure of an 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."
Twice; first in Month 22 (January 2018) and again in Month 43.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimated)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0486
  • A195010 (Other Identifier: UW Madison)
  • ENGR/INDUSTRIAL ENGR (Other Identifier: UW Madison)
  • 1R01DA041415 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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