The STop UNhealthy Substance Use Now Trial

NCT06524232 | Active Not Recruiting

• 1 other identifier: 1R18HS029782-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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

Conditions

Risky Health Behavior; Substance Use Disorders; Substance Abuse; Alcohol Use Disorder; Drinking, Alcohol; Substance Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (50)

• Number of adults with a positive screen for substance use disorder

  12 months

• Number of adults with a positive screen for substance use disorder

  24 months

• Percent of adults with a positive screen for substance use disorder

  12 months

• Percent of adults with a positive screen for substance use disorder

  24 months

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

  12 months

Other Outcomes (2)

• Association between implementation effectiveness and putative moderators and mediators

  12 months

• Association between implementation effectiveness and putative moderators and mediators

  24 months

Study Arms (4)

Practice Facilitation Only

ACTIVE COMPARATOR

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.

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.

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.

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.

Other: Practice Facilitation (PF); Other: Learning Collaborative (LC); Other: Performance Incentives (PI)

Interventions

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.

Practice Facilitation + Learning Collaborative; Practice Facilitation + Learning Collaborative + Performance Incentives; Practice Facilitation + Performance Incentives; Practice Facilitation Only

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.

Practice Facilitation + Learning Collaborative; Practice Facilitation + Learning Collaborative + Performance Incentives

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.

Practice Facilitation + Learning Collaborative + Performance Incentives; Practice Facilitation + Performance Incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

Bon Secours Mercy Health

Cincinnati, Ohio, 45237, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Association of Community Health Centers

Columbus, Ohio, 43215, United States

Location

Related Publications (1)

• 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.

  PMID: 41029867 DERIVED

MeSH Terms

Conditions

Health Risk Behaviors; Substance-Related Disorders; Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Drinking Behavior

Study Officials

• Daniel E Jonas, MD, MPH

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Division of General Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)