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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

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.


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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

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




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."



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926482


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

Publications:
Tremblay MA, Blanchard CM, Taylor S, Pelletier LG, Villeneuve M. Work Extrinsic and Intrinsic Motivation Scale: Its value for organizational psychology research. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement. 2009;41(4):213-226.
Warner M, Hedegaard H, Chen L. Trends in drug-poisoning deaths involving opioid analgesics and heroin: United States, 1999-2012. NCHS Health E-Stat. 2014
Centers for Disease Control and Prevention (CDC). Vital Signs: Opioid painkiller prescribing. 2014.
Singer JD, Willett JB. Applied longitudinal data analysis: modeling change and event occurrence. New York, NY: Oxford University Press; 2003.
MacKinnon DP. Introduction to statistical mediation analysis. New York, NY: Lawrence Erlbaum Associates; 2008.
Burke WW, Litwin GH. A causal model of organizational performance and change. In: Burke WW, Lake DG, Paine JW, eds. Organizational change: A comprehensive reader. San Francisco, CA: Jossey-Bass; 2009:273-299.
Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Treatment Episode Data Set (TEDS): 2002-2012. National Admissions to Substance Abuse Treatment Services. Rockville, MD: Substance Abuse Mental Health Services Administration;2014.
Substance Abuse and Mental Health Services Administration (SAMHSA). The N-SSATS Report: Trends in the Use of Methadone and Buprenorphine at Substance Abuse Treatment Facilities: 2003 to 2011. Rockville, MD: Center for Behavioral Health Statistics and Quality;2013.

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