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Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

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

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date November 28, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Number of assigned physician buprenorphine prescribing slots [ Time Frame: Monthly; beginning in Month 9 (November 2016) and continuing up to Month 46. ]
This is the number of assigned physician buprenorphine prescribing slots in specialty addiction treatment organizations.
Change History Complete list of historical versions of study NCT02926482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Organizational survey [ Time Frame: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38. ]
    Measures PRB implementation fidelity
  • 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.
  • 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."
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Physician Recruiter Resources Inventory [ Time Frame: Annual data collection, starting in Month 11 (January 2017) and continuing up to Month 46. ]
    Qualitative measure of a specialty addiction treatment organization's resources dedicated to physician recruitment. Collected via the Annual Organization Survey. Participants will read statements regarding their organization's resources dedicated to physician 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."
  • Physician Satisfaction [ Time Frame: Annual data collection; starting in Month 11 (January 2017) and continuing up to Month 46. ]
    Collected via the "Physician Worklife Survey." Qualitative measure of a physician's job satisfaction at the intervention site. Responses are recorded on a scale of 1-5, with 1 corresponding to "Not at all" and 5 corresponding to "Always" or "All of the time." Participants read a statement regarding their work life and rate how much they agree or disagree with that statement based on that 1-5 scale.
  • Number of buprenorphine prescribing slots open to a new consumer [ Time Frame: Monthly; beginning in Month 9 (November 2016) and continuing up to Month 46. ]
    This is the number of buprenorphine prescribing slots available to be assigned to new patients at the specialty addiction treatment organizations.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers
Official Title  ICMJE Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Prescriber Recruitment Bundle (PRB)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 26, 2018)
75
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
70
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02926482
Other Study ID Numbers  ICMJE 2016-0486
1R01DA041415 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Todd Molfenter Center for Health Enhancement Systems Studies, University of Wisconsin-Madison
PRS Account University of Wisconsin, Madison
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP