Clinical trial NCT06524232: The STop UNhealthy Substance Use Now Trial
Official title: The STop UNhealthy Substance Use Now Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Risky Health Behavior
Substance Use Disorders
Substance Abuse
Alcohol Use Disorder
Drinking, Alcohol
Substance Use
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Ohio Association of Community Health Centers (OACHC)
name: Bon Secours Mercy Health (BSMH)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-07-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adults screened for substance use disorder
timeFrame: 12 months
measure: Percent of adults screened for substance use disorder
timeFrame: 12 months
Secondary outcomes:
measure: Number of adults with a positive screen for substance use disorder
timeFrame: 12 months
measure: Number of adults with a positive screen for substance use disorder
timeFrame: 24 months
measure: Percent of adults with a positive screen for substance use disorder
timeFrame: 12 months
measure: Percent of adults with a positive screen for substance use disorder
timeFrame: 24 months
measure: Number of adults who received any evidence-based intervention for substance use disorder
timeFrame: 12 months
measure: Number of adults who received any evidence-based intervention for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received any evidence-based intervention for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received any evidence-based intervention for substance use disorder
timeFrame: 12 months
measure: Number of adults who received brief counseling for substance use disorder
timeFrame: 12 months
measure: Number of adults who received brief counseling for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received brief counseling for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received brief counseling for substance use disorder
timeFrame: 12 months
measure: Number of adults who received medication for substance use disorder
timeFrame: 12 months
measure: Number of adults who received medication for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received medication for substance use disorder
timeFrame: 24 months
measure: Percentage of adults who received medication for substance use disorder, including alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
timeFrame: 12 months
measure: Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
timeFrame: 24 months
measure: Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
timeFrame: 24 months
measure: Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
timeFrame: 12 months
measure: Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
timeFrame: 12 months
measure: Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
timeFrame: 12 months
measure: Number of adults with alcohol use disorder
timeFrame: 12 months
measure: Number of adults with alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults with alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults with alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received any evidence-based intervention for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received any evidence-based intervention for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received any evidence-based intervention for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received any evidence-based intervention for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received brief counseling for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received brief counseling for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received brief counseling for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received brief counseling for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received medication for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received medication for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received medication for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults who received medication for alcohol use disorder
timeFrame: 12 months
measure: Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
timeFrame: 12 months
measure: Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
timeFrame: 24 months
measure: Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
timeFrame: 24 months
measure: Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
timeFrame: 12 months
measure: Number of adults referred to specialty care for alcohol use disorder
timeFrame: 12 months
measure: Number of adults referred to specialty care for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults referred to specialty care for alcohol use disorder
timeFrame: 24 months
measure: Percentage of adults referred to specialty care for alcohol use disorder
timeFrame: 12 months
measure: Number of adults screened for substance use disorder
timeFrame: 24 months
measure: Percent of adults screened for substance use disorder
timeFrame: 24 months
Other outcomes:
measure: Association between implementation effectiveness and putative moderators and mediators
timeFrame: 12 months
measure: Association between implementation effectiveness and putative moderators and mediators
timeFrame: 24 months
Locations:
city: Cincinnati
country: United States
facility: Bon Secours Mercy Health
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Association of Community Health Centers
state: Ohio
Study officials:
affiliation: Ohio State University
name: Daniel E Jonas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: