NCT01702142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

4.8 years

First QC Date

September 28, 2012

Last Update Submit

November 28, 2018

Conditions

Keywords

Addiction Treatment

Outcome Measures

Primary Outcomes (1)

  • Buprenorphine Use

    Five Years

Study Arms (2)

NIATx Only

NIATx (Network for the Improvement of Addiction Treatment) organization change model only

NIATx and Advancing Recovery

Organizational and system changes

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treatment agencies and Ohio County Boards

You may qualify if:

  • Treatment agencies with greater than 75 admissions per year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio Department of Addiction Services

Columbus, Ohio, 43215, United States

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: NONE RETAINED

Biospecimens are not part of this study.

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Todd D Molfenter, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 5, 2012

Study Start

March 1, 2012

Primary Completion

December 31, 2016

Study Completion

February 28, 2018

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations