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Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescriber Recruitment Bundle (PRB)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder focused on measuring Evidence-based practice implementation, Buprenorphine, Addiction treatment, Extended-release naltrexone, Addiction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Florida Alcohol and Drug Abuse Association
  • Ohio Department of Mental Health and Addiction Services
  • Center for Health Enhancement Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PRB: organizations implementing the PRB

Arm Description

This arm will include 35 organizations who receive access to the Prescriber Recruitment Bundle (PRB) materials online via a secure website.

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).

Outcomes

Primary Outcome Measures

Buprenorphine slots and extended naltrexone capacity survey
Monthly number of assigned and open buprenorphine slots as well as extended-release naltrexone capacity and administrations over the past month.

Secondary Outcome Measures

Organizational survey
Measures PRB implementation fidelity
Physician Satisfaction
Collected via the "Physician Worklife Survey." Quantitative measure of a physician (or other prescribers) job satisfaction.
Qualitative surveys
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."

Full Information

First Posted
September 9, 2016
Last Updated
October 15, 2020
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02926482
Brief Title
Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers
Official Title
Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Evidence-based practice implementation, Buprenorphine, Addiction treatment, Extended-release naltrexone, Addiction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will include 35 organizations who receive access to the Prescriber Recruitment Bundle (PRB) materials online via a secure website.
Arm Title
PRB: organizations implementing the PRB
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Prescriber Recruitment Bundle (PRB)
Other Intervention Name(s)
PRB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Buprenorphine slots and extended naltrexone capacity survey
Description
Monthly number of assigned and open buprenorphine slots as well as extended-release naltrexone capacity and administrations over the past month.
Time Frame
Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.
Secondary Outcome Measure Information:
Title
Organizational survey
Description
Measures PRB implementation fidelity
Time Frame
Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
Title
Physician Satisfaction
Description
Collected via the "Physician Worklife Survey." Quantitative measure of a physician (or other prescribers) job satisfaction.
Time Frame
Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
Title
Qualitative surveys
Description
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."
Time Frame
Twice; first in Month 22 (January 2018) and again in Month 43.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Molfenter
Organizational Affiliation
Center for Health Enhancement Systems Studies, University of Wisconsin-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Alcohol and Drug Abuse Association
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Ohio Department of Mental Health and Addiction Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215-3430
Country
United States
Facility Name
Center for Health Enhancement Systems
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

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