AddictionNCT01702142
To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine
An observational study of Addiction, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Treatment agencies and Ohio County Boards
Who may be able to join
- Treatment agencies with greater than 75 admissions per year
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio Department of Addiction Services
Columbus, Ohio, 43215
About this study
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.
Read the 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.
- Conditions
- Addiction
- Keywords
- Addiction Treatment
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NIATx Only | NIATx (Network for the Improvement of Addiction Treatment) organization change model only | |
| NIATx and Advancing Recovery | Organizational and system changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buprenorphine Use
Measured: Five Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startMar 2012
- Primary completion31 Dec 2016
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Todd D Molfenter, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702142
- Sponsor's protocol ID
- Molfenter_2012_0008
- Other IDs
- 1R01DA030431-01A1
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2012
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23663749
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine
- ClinicalTrials.gov ID
- NCT01702142
- Acronym / sponsor ID
- Molfenter_2012_0008
- Conditions
- Addiction
- Keywords
- Addiction Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIATx Only | – | –NIATx (Network for the Improvement of Addiction Treatment) organization change model only |
| NIATx and Advancing Recovery | – | –Organizational and system changes |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Treatment agencies and Ohio County Boards
Key inclusion criteria (1 listed)
- Treatment agencies with greater than 75 admissions per year
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Buprenorphine Use
Time frame: Five Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Derived from this study: PubMed 23663749Molfenter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd D Molfenter, Ph.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buprenorphine Use (time frame: Five Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01702142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.