To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01702142
First received: September 28, 2012
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

A team of researchers from the University of Wisconsin-Madison College of Engineering and Oregon Health & Science University will test whether clinician training and the use of organizational change strategies are sufficient for disseminating an evidence-based practice (EBP), or if changes to both organizational systems and payer policy results in greater EBP use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based practices could provide a contribution to dissemination and implementation science. This study will employ an intervention that was developed through the Robert Wood Johnson Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs such as medication-assisted treatment for substance abuse disorders. The resulting "AR Framework" of payer and organizational change strategies will be tested against its ability to increase the use of the addiction medication buprenorphine as compared to organizational change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or opioid-based pain medications for non-medical use. Buprenorphine has experienced low adoption rates and is not a standard part of addiction treatment. In Ohio, the location of the study, deaths to due to accidental overdoses of opioids has increased by 304% over the past decade and surpassed auto accidents as the leading cause of accidental deaths in 2006. Ohio was selected for the study because of the public health significance of opioid abuse and because each county in Ohio acts as a stand-alone payer, offering 48 unique eligible payer environments. This trial will develop a deeper understanding of the role payers and treatment organizations play in implementing and disseminating EBPs and will focus on the public health issue of rising opioid abuse.


Condition
Addiction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Buprenorphine Use [ Time Frame: Five Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimens are not part of this study.


Estimated Enrollment: 15
Study Start Date: March 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
NIATx (Network for the Improved Treatment Change Model) Only
NIATx organization change model only
NIATx and Advancing Recovery
Organizational and system changes

Detailed Description:

Buprenorphine (EBP) use data will be collected from November, 2012 to May, 2016 through administrative databases located at the state of Ohio. Participants will be followed for the duration of Buprenorphine use that is an average of 5-7 months. Organizational and Payer data will be collected from January, 2013 to January, 2015. The data from the study will be analyzed and reported during January 2015 to February 2017.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Treatment agencies and Ohio County Boards

Criteria

Inclusion Criteria:

  • Treatment agencies with greater than 75 admissions per year

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702142

Locations
United States, Ohio
Ohio Department of Addiction Services
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Todd D Molfenter, Ph.D. University of Wisconsin, Madison
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01702142     History of Changes
Other Study ID Numbers: Molfenter_2012_008, 1R01DA030431-01A1
Study First Received: September 28, 2012
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Addiction Treatment

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014