The STop UNhealthy Substance Use Now Trial (STUN II)

The Ohio State University

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06524232

1R18HS029782-01 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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144 participants in 4 patient groups

Practice Facilitation Only

Active Comparator group

Description:

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

Treatment:

Other: Practice Facilitation (PF)

Practice Facilitation + Learning Collaborative

Experimental group

Description:

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.

Treatment:

Other: Practice Facilitation (PF)

Other: Learning Collaborative (LC)

Practice Facilitation + Performance Incentives

Experimental group

Description:

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.

Treatment:

Other: Performance Incentives (PI)

Other: Practice Facilitation (PF)

Practice Facilitation + Learning Collaborative + Performance Incentives

Experimental group

Description:

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.

Treatment:

Other: Performance Incentives (PI)

Other: Practice Facilitation (PF)

Other: Learning Collaborative (LC)