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Active, Not Recruiting

NCT Number: NCT06524232

The STop UNhealthy Substance Use Now Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Risky Health Behavior Alcohol Drinking Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Drinking, Alcohol Health Behavior Health Risk Behaviors Mental Disorders Substance Abuse Substance Use Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bon Secours Mercy Health, Cincinnati, Ohio, United States

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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

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Number of adults with a positive screen for substance use disorder

    Time frame: 12 months

    Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result

  2. Number of adults with a positive screen for substance use disorder

    Time frame: 24 months

    Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result

  3. Percent of adults with a positive screen for substance use disorder

    Time frame: 12 months

    Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result

  4. Percent of adults with a positive screen for substance use disorder

    Time frame: 24 months

    Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result

  5. Number of adults who received any evidence-based intervention for substance use disorder

    Time frame: 12 months

    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

  6. Number of adults who received any evidence-based intervention for substance use disorder

    Time frame: 24 months

    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

  7. Percentage of adults who received any evidence-based intervention for substance use disorder

    Time frame: 24 months

    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

  8. Percentage of adults who received any evidence-based intervention for substance use disorder

    Time frame: 12 months

    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

  9. Number of adults who received brief counseling for substance use disorder

    Time frame: 12 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling

  10. Number of adults who received brief counseling for substance use disorder

    Time frame: 24 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling

  11. Percentage of adults who received brief counseling for substance use disorder

    Time frame: 24 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling

  12. Percentage of adults who received brief counseling for substance use disorder

    Time frame: 12 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling

  13. Number of adults who received medication for substance use disorder

    Time frame: 12 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication

  14. Number of adults who received medication for substance use disorder

    Time frame: 24 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication

  15. Percentage of adults who received medication for substance use disorder

    Time frame: 24 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication

  16. Percentage of adults who received medication for substance use disorder, including alcohol use disorder

    Time frame: 12 months

    Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication

  17. 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

    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

  18. 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

    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

  19. 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

    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

  20. 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

    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

  21. Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder

    Time frame: 12 months

    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.)

  22. Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder

    Time frame: 24 months

    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.)

  23. Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder

    Time frame: 24 months

    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. Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder

    Time frame: 12 months

    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.)

  25. Number of adults with alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder

  26. Number of adults with alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder

  27. Percentage of adults with alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder

  28. Percentage of adults with alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder

  29. Number of adults who received any evidence-based intervention for alcohol use disorder

    Time frame: 12 months

    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)

  30. Number of adults who received any evidence-based intervention for alcohol use disorder

    Time frame: 24 months

    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)

  31. Percentage of adults who received any evidence-based intervention for alcohol use disorder

    Time frame: 24 months

    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)

  32. Percentage of adults who received any evidence-based intervention for alcohol use disorder

    Time frame: 12 months

    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)

  33. Number of adults who received brief counseling for alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling

  34. Number of adults who received brief counseling for alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling

  35. Percentage of adults who received brief counseling for alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling

  36. Percentage of adults who received brief counseling for alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling

  37. Number of adults who received medication for alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older identified as having alcohol use disorder, number who received medication

  38. Number of adults who received medication for alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older identified as having alcohol use disorder, number who received medication

  39. Percentage of adults who received medication for alcohol use disorder

    Time frame: 24 months

    Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication

  40. Percentage of adults who received medication for alcohol use disorder

    Time frame: 12 months

    Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication

  41. Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment

    Time frame: 12 months

    Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months

  42. Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment

    Time frame: 24 months

    Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months

  43. Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment

    Time frame: 24 months

    Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months

  44. Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment

    Time frame: 12 months

    Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months

  45. Number of adults referred to specialty care for alcohol use disorder

    Time frame: 12 months

    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.)

  46. Number of adults referred to specialty care for alcohol use disorder

    Time frame: 24 months

    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.)

  47. Percentage of adults referred to specialty care for alcohol use disorder

    Time frame: 24 months

    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.)

  48. Percentage of adults referred to specialty care for alcohol use disorder

    Time frame: 12 months

    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.)

  49. Number of adults screened for substance use disorder

    Time frame: 24 months

    Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool

  50. Percent of adults screened for substance use disorder

    Time frame: 24 months

    Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool

Other outcomes

  1. Association between implementation effectiveness and putative moderators and mediators

    Time frame: 12 months

    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)

  2. Association between implementation effectiveness and putative moderators and mediators

    Time frame: 24 months

    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)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Bon Secours Mercy Health (BSMH)
  • Ohio Association of Community Health Centers (OACHC)

Registry information

Acronym: STUN II

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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