The STop UNhealthy Substance Use Now Trial (STUN II)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use; Substance Use Disorders; Alcohol Use Disorder; Substance Abuse; Drinking, Alcohol; Risky Health Behavior
• Intervention / Treatment: Other: Practice Facilitation (PF); Other: Learning Collaborative (LC); Other: Performance Incentives (PI)

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45237
      • Bon Secours Mercy Health
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Columbus, Ohio, United States, 43215
      • Ohio Association of Community Health Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Practice Facilitation Only; Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.	Other: 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.
Experimental: Practice Facilitation + Learning Collaborative; 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.	Other: 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: 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.
Experimental: Practice Facilitation + Performance Incentives; 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.	Other: 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: 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.
Experimental: Practice Facilitation + Learning Collaborative + Performance Incentives; 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.	Other: 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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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.)	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.)	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.)	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.)	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	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	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	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	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)	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)	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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.)	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.)	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.)	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.)	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	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	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between implementation effectiveness and putative moderators and mediators	Longitudinal mixed-methods evaluation (surveys, interviews) to describe the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate)	12 months
Association between implementation effectiveness and putative moderators and mediators	Longitudinal mixed-methods evaluation (surveys, interviews) to describe the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate)	24 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Ohio Association of Community Health Centers (OACHC); Bon Secours Mercy Health (BSMH)
• Investigators: Principal Investigator: Daniel E Jonas, MD, MPH, Ohio State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Behavior; Health Behavior; Alcoholism; Alcohol Drinking; Substance-Related Disorders; Health Risk Behaviors
• Other Study ID Numbers: 1R18HS029782-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No