Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02926482|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Behavioral: Prescriber Recruitment Bundle (PRB)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||75 participants|
|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|
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
- 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.
- 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."
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
|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|
|Principal Investigator:||Todd Molfenter||Center for Health Enhancement Systems Studies, University of Wisconsin-Madison|