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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01702142
Other study ID # Molfenter_2012_0008
Secondary ID 1R01DA030431-01A
Status Completed
Phase
First received
Last updated
Start date March 2012
Est. completion date February 28, 2018

Study information

Verified date November 2018
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 28, 2018
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria:

- Treatment agencies with greater than 75 admissions per year

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Ohio Department of Addiction Services Columbus Ohio

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Buprenorphine Use Five Years
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