Risky Health BehaviorSTUN IINCT06524232
The STop UNhealthy Substance Use Now Trial
A study testing Practice Facilitation (PF), Learning Collaborative (LC) and Performance Incentives (PI) in people with Risky Health Behavior and Substance Use Disorders, run by Ohio State University at 3 sites in United States.
Trial summary
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risky Health Behavior, Substance Use Disorders, Substance Abuse
- What is being tested?
- Practice Facilitation (PF), Learning Collaborative (LC) and Performance Incentives (PI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Sep 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinic staff members from primary care practices who provide care for adult patients and have a leadership role within the practice (e.g. lead physician, practice manager, lead medical assistant/nurse, clinical champion)
Who cannot join
- Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bon Secours Mercy Health
Cincinnati, Ohio, 45237
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Ohio Association of Community Health Centers
Columbus, Ohio, 43215
About this study
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices
Read the detailed description
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices
Specific aim 1 (primary aim) will compare the effect of learning collaborative (LC) participation, performance incentives (PI), or their combination, with practice facilitation (PF) only, on implementation of evidence-based screening for SUDs.
Specific aim 2 (secondary aim) will compare the effect of LC participation, PI, or their combination, with PF only, on implementation of evidence-based interventions for SUDs, including (a) brief counseling, (b) medications (e.g., buprenorphine, naltrexone) and adherence to them, and (c) referral to specialty care.
Specific aims 1 and 2 will produce fundamentally important evidence about the comparative effectiveness of PF, PF+LC, PF+PI, and PF+LC+PI strategies on uptake of evidence-based screening and interventions for SUD when delivered to primary care practices.
Specific aim 3 (exploratory aim) will use a longitudinal mixed-methods evaluation to assess the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate). Aim 3 will generate scientific knowledge about mechanisms of change (why and how the various strategies work) in primary care settings.
- Conditions
- Risky Health Behavior, Substance Use Disorders, Substance Abuse, Alcohol Use Disorder, Drinking, Alcohol, Substance Use
- Being tested
- Practice Facilitation (PF), Learning Collaborative (LC), Performance Incentives (PI)
- Medical subject headings
- Health Risk Behaviors, Substance-Related Disorders, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Facilitation (PF)Other
Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options.
Learning Collaborative (LC)Other
Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. Participant-generated ideas for topics to be covered during virtual LC sessions will be encouraged. Some specific topics will include optimal SUD screening approaches; prescribing medications for opioid use disorder (OUD) in primary care; pragmatic issues around integrated SUD care within primary care such as compliance with state and federal requirements, note templates/visit frequency, and when/how to escalate care for patients with severe or worsening SUD; medications for alcohol use disorder (AUD); and motivational interviewing.
Performance Incentives (PI)Other
We will work closely with key stakeholders and the Steering Committee to co-design the PI strategy, refining the specific performance metrics to ensure that they align with other ongoing efforts in our partnering organizations. We plan to base the incentive on achieving a threshold target for the percentage of eligible adult patients screened for SUD, or the percentage improvement in screening, for quarters 1 and 2. For quarters 3 and 4, after practices have had time to implement and improve their processes for screening for SUD, the incentives will evolve to become a composite of (1) patients screened for SUD (the same as used in quarters 1 and 2) and (2) achieving a threshold target for the percentage of persons with SUD who received evidence-based interventions.
| Study group | Role | What they receive |
|---|---|---|
| Practice Facilitation Only | Active comparator | Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Receives: Other: Practice Facilitation (PF) |
| Practice Facilitation + Learning Collaborative | Experimental | Practice Facilitation (PF): Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.
Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. Receives: Other: Practice Facilitation (PF); Other: Learning Collaborative (LC) |
| Practice Facilitation + Performance Incentives | Experimental | Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.
Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter. Receives: Other: Practice Facilitation (PF); Other: Performance Incentives (PI) |
| Practice Facilitation + Learning Collaborative + Performance Incentives | Experimental | Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.
Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A.
Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter. Receives: Other: Practice Facilitation (PF); Other: Learning Collaborative (LC); Other: Performance Incentives (PI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adults screened for substance use disorder
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Measured: 12 months
Percent of adults screened for substance use disorder
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Measured: 12 months
Secondary outcomes (50)
Number of adults with a positive screen for substance use disorder
Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result
Measured: 12 months
Number of adults with a positive screen for substance use disorder
Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result
Measured: 24 months
Percent of adults with a positive screen for substance use disorder
Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result
Measured: 12 months
Percent of adults with a positive screen for substance use disorder
Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result
Measured: 24 months
Number of adults who received any evidence-based intervention for substance use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who received brief counseling, medication, or referral to specialty care
Measured: 12 months
Number of adults who received any evidence-based intervention for substance use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who received brief counseling, medication, or referral to specialty care
Measured: 24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage that received brief counseling, medication, or referral to specialty care
Measured: 24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage that received brief counseling, medication, or referral to specialty care
Measured: 12 months
Number of adults who received brief counseling for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling
Measured: 12 months
Number of adults who received brief counseling for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling
Measured: 24 months
Percentage of adults who received brief counseling for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling
Measured: 24 months
Percentage of adults who received brief counseling for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling
Measured: 12 months
Number of adults who received medication for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication
Measured: 12 months
Number of adults who received medication for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication
Measured: 24 months
Percentage of adults who received medication for substance use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
Measured: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
Measured: 12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, number who adhered to treatment for 6 months
Measured: 12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, number who adhered to treatment for 6 months
Measured: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, percentage who adhered to treatment for 6 months
Measured: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, percentage who adhered to treatment for 6 months
Measured: 12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 12 months
Number of adults with alcohol use disorder
Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder
Measured: 12 months
Number of adults with alcohol use disorder
Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder
Measured: 24 months
Percentage of adults with alcohol use disorder
Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder
Measured: 24 months
Percentage of adults with alcohol use disorder
Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder
Measured: 12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
Measured: 12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
Measured: 24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
Measured: 24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
Measured: 12 months
Number of adults who received brief counseling for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling
Measured: 12 months
Number of adults who received brief counseling for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling
Measured: 24 months
Percentage of adults who received brief counseling for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling
Measured: 24 months
Percentage of adults who received brief counseling for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling
Measured: 12 months
Number of adults who received medication for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received medication
Measured: 12 months
Number of adults who received medication for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, number who received medication
Measured: 24 months
Percentage of adults who received medication for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication
Measured: 24 months
Percentage of adults who received medication for alcohol use disorder
Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication
Measured: 12 months
Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months
Measured: 12 months
Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months
Measured: 24 months
Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months
Measured: 24 months
Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months
Measured: 12 months
Number of adults referred to specialty care for alcohol use disorder
Of those aged 18 or older who were identified as having alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 12 months
Number of adults referred to specialty care for alcohol use disorder
Of those aged 18 or older who were identified as having alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 24 months
Percentage of adults referred to specialty care for alcohol use disorder
Of those aged 18 or older who were identified as having alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 24 months
Percentage of adults referred to specialty care for alcohol use disorder
Of those aged 18 or older who were identified as having alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
Measured: 12 months
Number of adults screened for substance use disorder
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Measured: 24 months
Percent of adults screened for substance use disorder
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start16 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
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 Risky Health BehaviorStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- STUN II is a 48-site randomized 2x2 factorial trial to evaluate the comparative effectiveness of implementation strategies, including practice facilitation (PF), PF + learning collaborative (LC), PF + performance incentives (PI), and PF+LC+PI, on implementation of screening for and delivery of evidence-based interventions for substance use disorders (SUD) in primary care. We will use a stratified block randomization strategy with a block size of 12 practices to ensure a high degree of balance between study arms. The implementation phase will last for 12 months, and we will conduct 12-month post-implementation assessments to assess sustainment. The 2x2 design will allow us to assess the improvement in rates of screening and delivery of evidence-based interventions for SUDs in primary care with PF alone and the incremental benefit of LC, PI, or their combination, to inform primary care practices and health systems about optimal implementation strategies.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Association of Community Health Centers (OACHC), Bon Secours Mercy Health (BSMH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Dan.Jonas, Ohio State University
- Investigators
- Daniel E Jonas, MD, MPH, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524232
- Sponsor's protocol ID
- 1R18HS029782-01
- Acronym
- STUN II
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jonas DE, Brill SB, Fried M, Brouwer L, Riley S, MacEwan SR, Hyer M, Palettas M, Hall OT, Vilensky M, Teater J, Carson WF 2nd, Wei L, Garner BR. The STop UNhealthy substance use now (STUN II) trial: protocol for a 48-site cluster randomized 2 x 2 factorial implementation trial to improve evidence-based screening and interventions for substance use disorder within primary care. Implement Sci. 2025 Sep 30;20(1):40. doi: 10.1186/s13012-025-01454-3.
PubMed 41029867
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STop UNhealthy Substance Use Now Trial
- ClinicalTrials.gov ID
- NCT06524232
- Acronym / sponsor ID
- STUN II / 1R18HS029782-01
- Conditions
- Risky Health Behavior, Substance Use Disorders, Substance Abuse, Alcohol Use Disorder, Drinking, Alcohol, Substance Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Ohio Association of Community Health Centers (OACHC), Bon Secours Mercy Health (BSMH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- 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.
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices
Detailed description
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices
Specific aim 1 (primary aim) will compare the effect of learning collaborative (LC) participation, performance incentives (PI), or their combination, with practice facilitation (PF) only, on implementation of evidence-based screening for SUDs.
Specific aim 2 (secondary aim) will compare the effect of LC participation, PI, or their combination, with PF only, on implementation of evidence-based interventions for SUDs, including (a) brief counseling, (b) medications (e.g., buprenorphine, naltrexone) and adherence to them, and (c) referral to specialty care.
Specific aims 1 and 2 will produce fundamentally important evidence about the comparative effectiveness of PF, PF+LC, PF+PI, and PF+LC+PI strategies on uptake of evidence-based screening and interventions for SUD when delivered to primary care practices.
Specific aim 3 (exploratory aim) will use a longitudinal mixed-methods evaluation to assess the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate). Aim 3 will generate scientific knowledge about mechanisms of change (why and how the various strategies work) in primary care settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- STUN II is a 48-site randomized 2x2 factorial trial to evaluate the comparative effectiveness of implementation strategies, including practice facilitation (PF), PF + learning collaborative (LC), PF + performance incentives (PI), and PF+LC+PI, on implementation of screening for and delivery of evidence-based interventions for substance use disorders (SUD) in primary care. We will use a stratified block randomization strategy with a block size of 12 practices to ensure a high degree of balance between study arms. The implementation phase will last for 12 months, and we will conduct 12-month post-implementation assessments to assess sustainment. The 2x2 design will allow us to assess the improvement in rates of screening and delivery of evidence-based interventions for SUDs in primary care with PF alone and the incremental benefit of LC, PI, or their combination, to inform primary care practices and health systems about optimal implementation strategies.
| Arm | Type | Receives |
|---|---|---|
| Practice Facilitation Only | Active comparator | Other: Practice Facilitation (PF)Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. |
| Practice Facilitation + Learning Collaborative | Experimental | Other: Practice Facilitation (PF), Other: Learning Collaborative (LC)Practice Facilitation (PF): Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. |
| Practice Facilitation + Performance Incentives | Experimental | Other: Practice Facilitation (PF), Other: Performance Incentives (PI)Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter. |
| Practice Facilitation + Learning Collaborative + Performance Incentives | Experimental | Other: Practice Facilitation (PF), Other: Learning Collaborative (LC), Other: Performance Incentives (PI)Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinic staff members from primary care practices who provide care for adult patients and have a leadership role within the practice (e.g. lead physician, practice manager, lead medical assistant/nurse, clinical champion)
Key exclusion criteria (1 listed)
- Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study
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 |
|---|---|---|
| Practice Facilitation (PF)Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options. | Other | Practice Facilitation + Learning Collaborative, Practice Facilitation + Learning Collaborative + Performance Incentives, Practice Facilitation + Performance Incentives, Practice Facilitation Only |
| Learning Collaborative (LC)Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. Participant-generated ideas for topics to be covered during virtual LC sessions will be encouraged. Some specific topics will include optimal SUD screening approaches; prescribing medications for opioid use disorder (OUD) in primary care; pragmatic issues around integrated SUD care within primary care such as compliance with state and federal requirements, note templates/visit frequency, and when/how to escalate care for patients with severe or worsening SUD; medications for alcohol use disorder (AUD); and motivational interviewing. | Other | Practice Facilitation + Learning Collaborative, Practice Facilitation + Learning Collaborative + Performance Incentives |
| Performance Incentives (PI)We will work closely with key stakeholders and the Steering Committee to co-design the PI strategy, refining the specific performance metrics to ensure that they align with other ongoing efforts in our partnering organizations. We plan to base the incentive on achieving a threshold target for the percentage of eligible adult patients screened for SUD, or the percentage improvement in screening, for quarters 1 and 2. For quarters 3 and 4, after practices have had time to implement and improve their processes for screening for SUD, the incentives will evolve to become a composite of (1) patients screened for SUD (the same as used in quarters 1 and 2) and (2) achieving a threshold target for the percentage of persons with SUD who received evidence-based interventions. | Other | Practice Facilitation + Learning Collaborative + Performance Incentives, Practice Facilitation + Performance Incentives |
Primary outcome
Number of adults screened for substance use disorder
Time frame: 12 months
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Percent of adults screened for substance use disorder
Time frame: 12 months
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
50 secondary outcomes
Number of adults with a positive screen for substance use disorder
Time frame: 12 months
Number of adults with a positive screen for substance use disorder
Time frame: 24 months
Percent of adults with a positive screen for substance use disorder
Time frame: 12 months
Percent of adults with a positive screen for substance use disorder
Time frame: 24 months
Number of adults who received any evidence-based intervention for substance use disorder
Time frame: 12 months
Number of adults who received any evidence-based intervention for substance use disorder
Time frame: 24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Time frame: 24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Time frame: 12 months
Number of adults who received brief counseling for substance use disorder
Time frame: 12 months
Number of adults who received brief counseling for substance use disorder
Time frame: 24 months
Percentage of adults who received brief counseling for substance use disorder
Time frame: 24 months
Percentage of adults who received brief counseling for substance use disorder
Time frame: 12 months
Number of adults who received medication for substance use disorder
Time frame: 12 months
Number of adults who received medication for substance use disorder
Time frame: 24 months
Percentage of adults who received medication for substance use disorder
Time frame: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder
Time frame: 12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time frame: 12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time frame: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time frame: 24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time frame: 12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time frame: 12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time frame: 24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time frame: 24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time frame: 12 months
Number of adults with alcohol use disorder
Time frame: 12 months
Number of adults with alcohol use disorder
Time frame: 24 months
Percentage of adults with alcohol use disorder
Time frame: 24 months
Percentage of adults with alcohol use disorder
Time frame: 12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Time frame: 12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Time frame: 24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Time frame: 24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Time frame: 12 months
Number of adults who received brief counseling for alcohol use disorder
Time frame: 12 months
Number of adults who received brief counseling for alcohol use disorder
Time frame: 24 months
Percentage of adults who received brief counseling for alcohol use disorder
Time frame: 24 months
Percentage of adults who received brief counseling for alcohol use disorder
Time frame: 12 months
Number of adults who received medication for alcohol use disorder
Time frame: 12 months
Number of adults who received medication for alcohol use disorder
Time frame: 24 months
Percentage of adults who received medication for alcohol use disorder
Time frame: 24 months
Percentage of adults who received medication for alcohol use disorder
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 41029867Jonas DE, Brill SB, Fried M, Brouwer L, Riley S, MacEwan SR, Hyer M, Palettas M, Hall OT, Vilensky M, Teater J, Carson WF 2nd, Wei L, Garner BR. The STop UNhealthy substance use now (STUN II) trial: protocol for a 48-site cluster randomized 2 x 2 factorial implementation trial to improve evidence-based screening and interventions for substance use disorder within primary care. Implement Sci. 2025 Sep 30;20(1):40. doi: 10.1186/s13012-025-01454-3.
- 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.
Daniel E Jonas, MD, MPH principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation (PF), Learning Collaborative (LC) and Performance Incentives (PI) in people with Risky Health Behavior and Substance Use Disorders, run by Ohio State University at 3 sites 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of adults screened for substance use disorder (time frame: 12 months). The study lists 2 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 NCT06524232, 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 25 Mar 2026.