Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

NCT02926482 | Completed DMC

• 4 other identifiers: 2016-04861R01DA041415A195010ENGR/INDUSTRIAL ENGR
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid-use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.

Secondary Outcomes (3)

• Organizational survey

  Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.

• Physician Satisfaction

  Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.

• Qualitative surveys

  Twice; first in Month 22 (January 2018) and again in Month 43.

Study Arms (2)

Control

NO INTERVENTION

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

PRB: organizations implementing the PRB

EXPERIMENTAL

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)

Interventions

Prescriber Recruitment Bundle (PRB) BEHAVIORAL

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.

Also known as: PRB

PRB: organizations implementing the PRB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Florida Alcohol and Drug Abuse Association

Tallahassee, Florida, 32308, United States

Location

Ohio Department of Mental Health and Addiction Services

Columbus, Ohio, 43215-3430, United States

Location

Center for Health Enhancement Systems

Madison, Wisconsin, 53706, United States

Location

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MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Todd Molfenter

  Center for Health Enhancement Systems Studies, University of Wisconsin-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: October 6, 2016
• Study Start: October 26, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 13, 2024

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)