Opioid-use DisorderNCT04363320
Fostering MAT Use in Justice Populations
A study testing NIATx Coaching and ECHO in people with Opioid-use Disorder and Recidivism, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Recidivism
- What is being tested?
- NIATx Coaching and ECHO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.
Read the detailed description
In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings.
The trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.
- Conditions
- Opioid-use Disorder, Recidivism
- Being tested
- NIATx Coaching, ECHO
- Keywords
- MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency
- Medical subject headings
- Opioid-Related Disorders, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIATx CoachingBehavioural
NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.
ECHOBehavioural
Also called Extension for Community Healthcare Outcomes
The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose NIATx Coaching & ECHO | Experimental | * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls Receives: Behavioral: NIATx Coaching; Behavioral: ECHO |
| Low-Dose NIATx Coaching & ECHO | Experimental | * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls Receives: Behavioral: NIATx Coaching; Behavioral: ECHO |
| High-Dose NIATx Coaching & No ECHO | Experimental | * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team Receives: Behavioral: NIATx Coaching |
| Low-Dose NIATx Coaching & No ECHO | Experimental | * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team Receives: Behavioral: NIATx Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Measured: baseline to 12 months
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Measured: 13 months, 24 months
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Measured: baseline to 12 months
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Measured: 13 months to 24 months
Change in Number of Prescribers Using MOUD
The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.
Measured: baseline, 12 months, 24 months
Secondary outcomes (1)
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months \& 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention.
Measured: baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start30 Jul 2020
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The proposed study will implement a cluster randomized block design where staff are nested within sites. The community-based provider sites and jails will be grouped into homogeneous blocks and then randomly assigned into 2x2 factorial design for each block. The forty-eights sites will be assigned to one of four study arms using a matching strategy within the blocks that groups four jail-clinic combination together prior to randomization. Each jail and cognitive behavioral (CB) treatment provider (or clinic) in these combinations will be treated as a site.
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- George Mason University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Todd Molfenter, PhD, Principal investigator, University of Wisconsin, MadisonFaye Taxman, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363320
- Sponsor's protocol ID
- 2019-1473
- Other IDs
- 3U2CDA050097-01S1, 20200548, A195010, ENGR/CHESS PROGRAM
- Status last verified
- May 2025
- First submitted
- 23 Apr 2020
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molfenter T, Vechinski J, Kim JS, Zhang J, Meng L, Tveit J, Madden L, Taxman FS. Assessing the comparative effectiveness of ECHO and coaching implementation strategies in a jail/provider MOUD implementation trial. Implement Sci. 2025 Feb 3;20(1):7. doi: 10.1186/s13012-025-01419-6.
PubMed 39901259
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering MAT Use in Justice Populations
- ClinicalTrials.gov ID
- NCT04363320
- Acronym / sponsor ID
- 2019-1473
- Conditions
- Opioid-use Disorder, Recidivism
- Keywords
- MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- George Mason University, National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.
Detailed description
In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings.
The trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The proposed study will implement a cluster randomized block design where staff are nested within sites. The community-based provider sites and jails will be grouped into homogeneous blocks and then randomly assigned into 2x2 factorial design for each block. The forty-eights sites will be assigned to one of four study arms using a matching strategy within the blocks that groups four jail-clinic combination together prior to randomization. Each jail and cognitive behavioral (CB) treatment provider (or clinic) in these combinations will be treated as a site.
| Arm | Type | Receives |
|---|---|---|
| High-Dose NIATx Coaching & ECHO | Experimental | Behavioral: NIATx Coaching, Behavioral: ECHO* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team * Prescribers participate in 12 monthly (one-hour) scheduled video conference calls |
| Low-Dose NIATx Coaching & ECHO | Experimental | Behavioral: NIATx Coaching, Behavioral: ECHO* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team * Prescribers participate in 12 monthly (one-hour) scheduled video conference calls |
| High-Dose NIATx Coaching & No ECHO | Experimental | Behavioral: NIATx Coaching* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team |
| Low-Dose NIATx Coaching & No ECHO | Experimental | Behavioral: NIATx Coaching* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIATx CoachingNIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes. | Behavioural | High-Dose NIATx Coaching & ECHO, High-Dose NIATx Coaching & No ECHO, Low-Dose NIATx Coaching & ECHO, Low-Dose NIATx Coaching & No ECHO |
| ECHOAlso: Extension for Community Healthcare OutcomesThe ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone. | Behavioural | High-Dose NIATx Coaching & ECHO, Low-Dose NIATx Coaching & ECHO |
Primary outcome
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase
Time frame: baseline to 12 months
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase
Time frame: 13 months, 24 months
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase
Time frame: baseline to 12 months
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase
Time frame: 13 months to 24 months
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Change in Number of Prescribers Using MOUD
Time frame: baseline, 12 months, 24 months
The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.
1 secondary outcome
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
Time frame: baseline, 12 months, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39901259Molfenter T, Vechinski J, Kim JS, Zhang J, Meng L, Tveit J, Madden L, Taxman FS. Assessing the comparative effectiveness of ECHO and coaching implementation strategies in a jail/provider MOUD implementation trial. Implement Sci. 2025 Feb 3;20(1):7. doi: 10.1186/s13012-025-01419-6.
- Individual participant dataSharing planned: No
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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 Molfenter, PhD principal investigator
University of Wisconsin, Madison
Faye Taxman, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIATx Coaching and ECHO in people with Opioid-use Disorder and Recidivism, 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 0 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 28 May 2025. 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?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase (time frame: baseline to 12 months). The study lists 5 primary outcomes in all. 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 NCT04363320, 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 28 May 2025.