Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

Opioid-use Disorder Clinical Trial

Official title:

Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926482
• Other study ID #: 2016-0486
• Secondary ID: 1R01DA041415A195
• Status: Completed
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: October 2019

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio Department of Mental Health and Addiction Services	Columbus	Ohio
United States	Center for Health Enhancement Systems	Madison	Wisconsin
United States	Florida Alcohol and Drug Abuse Association	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (29)

Berglund M. A better widget? Three lessons for improving addiction treatment from a meta-analytical study. Addiction. 2005 Jun;100(6):742-50. — View Citation

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.

Centers for Disease Control and Prevention (CDC). Vital Signs: Opioid painkiller prescribing. 2014.

Chen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8. — View Citation

Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, Collins J, Raisch D, Casadonte P, Goldsmith RJ, Ling W, Malkerneker U, McNicholas L, Renner J, Stine S, Tusel D; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003 Sep 4;349(10):949-58. — View Citation

Goldstein MG, Niaura R, Willey C, Kazura A, Rakowski W, DePue J, Park E. An academic detailing intervention to disseminate physician-delivered smoking cessation counseling: smoking cessation outcomes of the Physicians Counseling Smokers Project. Prev Med. 2003 Feb;36(2):185-96. — View Citation

Hoffman KA, Ford JH 2nd, Choi D, Gustafson DH, McCarty D. Replication and sustainability of improved access and retention within the Network for the Improvement of Addiction Treatment. Drug Alcohol Depend. 2008 Nov 1;98(1-2):63-9. doi: 10.1016/j.drugalcdep.2008.04.016. Epub 2008 Jun 18. — View Citation

Horgan CM, Reif S, Hodgkin D, Garnick DW, Merrick EL. Availability of addiction medications in private health plans. J Subst Abuse Treat. 2008 Mar;34(2):147-56. Epub 2007 May 17. — View Citation

Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010 Dec;15(4):309-34. doi: 10.1037/a0020761. — View Citation

Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. — View Citation

Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11. — View Citation

Klein KJ, Conn AB, Sorra JS. Implementing computerized technology: an organizational analysis. J Appl Psychol. 2001 Oct;86(5):811-24. — View Citation

Knudsen HK, Abraham AJ, Oser CB. Barriers to the implementation of medication-assisted treatment for substance use disorders: the importance of funding policies and medical infrastructure. Eval Program Plann. 2011 Nov;34(4):375-81. doi: 10.1016/j.evalprogplan.2011.02.004. Epub 2011 Mar 2. — View Citation

Knudsen HK, Abraham AJ, Roman PM. Adoption and implementation of medications in addiction treatment programs. J Addict Med. 2011 Mar;5(1):21-7. doi: 10.1097/ADM.0b013e3181d41ddb. — View Citation

MacKinnon DP. Introduction to statistical mediation analysis. New York, NY: Lawrence Erlbaum Associates; 2008.

Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;(2):CD002207. doi: 10.1002/14651858.CD002207.pub4. Review. — View Citation

McCarty D, Gustafson DH, Wisdom JP, Ford J, Choi D, Molfenter T, Capoccia V, Cotter F. The Network for the Improvement of Addiction Treatment (NIATx): enhancing access and retention. Drug Alcohol Depend. 2007 May 11;88(2-3):138-45. Epub 2006 Nov 28. — View Citation

Molfenter T, Kim JS, Quanbeck A, Patel-Porter T, Starr S, McCarty D. Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial. Implement Sci. 2013 May 10;8:50. doi: 10.1186/1748-5908-8-50. — View Citation

Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine Prescribing Availability in a Sample of Ohio Specialty Treatment Organizations. J Addict Behav Ther Rehabil. 2015;4(2). pii: 1000140. — View Citation

Raudenbush SW, Liu X. Statistical power and optimal design for multisite randomized trials. Psychol Methods. 2000 Jun;5(2):199-213. — View Citation

Schroeder SA. An agenda to combat substance abuse. Health Aff (Millwood). 2005 Jul-Aug;24(4):1005-13. — View Citation

Singer JD, Willett JB. Applied longitudinal data analysis: modeling change and event occurrence. New York, NY: Oxford University Press; 2003.

Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56. — View Citation

Stein BD, Gordon AJ, Dick AW, Burns RM, Pacula RL, Farmer CM, Leslie DL, Sorbero M. Supply of buprenorphine waivered physicians: the influence of state policies. J Subst Abuse Treat. 2015 Jan;48(1):104-11. doi: 10.1016/j.jsat.2014.07.010. Epub 2014 Aug 2. — View Citation

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.

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.

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

Williams ES, Konrad TR, Linzer M, McMurray J, Pathman DE, Gerrity M, Schwartz MD, Scheckler WE, Van Kirk J, Rhodes E, Douglas J. Refining the measurement of physician job satisfaction: results from the Physician Worklife Survey. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999 Nov;37(11):1140-54. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Organizational survey	Measures PRB implementation fidelity	Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
Secondary	Physician Satisfaction	Collected via the "Physician Worklife Survey." Quantitative measure of a physician (or other prescribers) job satisfaction.	Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
Secondary	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."	Twice; first in Month 22 (January 2018) and again in Month 43.