The STop UNhealthy Substance Use Now Trial

Not Applicable

Recruiting

• Conditions: Substance Use Disorders; Alcohol Use Disorder; Drinking, Alcohol; Risky Health Behavior; Substance Use; Substance Abuse
• Interventions: Other: Practice Facilitation (PF); Other: Performance Incentives (PI); Other: Learning Collaborative (LC)

• Registration Number: NCT06524232
• Lead Sponsor: Ohio State University

Brief 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 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 Timeline

• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Study Start: 2024-09-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Practice Facilitation + Learning Collaborative	Practice Facilitation (PF)	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	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 Only	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	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	Practice Facilitation (PF)	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	Practice Facilitation (PF)	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.
Practice Facilitation + Learning Collaborative + Performance Incentives	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.
Practice Facilitation + Learning Collaborative + Performance Incentives	Learning Collaborative (LC)	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.

Primary Outcome Measures

Name	Time	Method
Number of adults screened for substance use disorder	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	12 months	Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool

Secondary Outcome Measures

Name	Time	Method
Percentage of adults who received medication for substance use disorder, including alcohol use disorder	12 months	Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment	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
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment	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
Percent of adults with a positive screen for substance use disorder	24 months	Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result
Number of adults with a positive screen for substance use disorder	24 months	Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result
Percentage of adults who received medication for substance use disorder	24 months	Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
Number of adults who received any evidence-based intervention for alcohol use disorder	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)
Number of adults who received medication for alcohol use disorder	24 months	Of those aged 18 or older identified as having alcohol use disorder, number who received medication
Percentage of adults who received medication for alcohol use disorder	12 months	Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication
Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment	12 months	Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months
Number of adults referred to specialty care for alcohol use disorder	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.)
Number of adults screened for substance use disorder	24 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	24 months	Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Number of adults who received any evidence-based intervention for substance use disorder	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
Number of adults who received medication for substance use disorder	24 months	Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication
Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment	24 months	Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months
Percentage of adults who received any evidence-based intervention for substance use disorder	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
Number of adults who received brief counseling for substance use disorder	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
Percentage of adults who received brief counseling for substance use disorder	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
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder	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.)
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder	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.)
Number of adults with alcohol use disorder	24 months	Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder
Percentage of adults with alcohol use disorder	12 months	Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder
Percentage of adults who received any evidence-based intervention for alcohol use disorder	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)
Percentage of adults referred to specialty care for alcohol use disorder	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.)
Number of adults who received brief counseling for alcohol use disorder	24 months	Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling
Percentage of adults who received brief counseling for alcohol use disorder	12 months	Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling

Trial Locations

Locations (3)

Bon Secours Mercy Health; 🇺🇸 Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Ohio Association of Community Health Centers; 🇺🇸 Columbus, Ohio, United States