The STop UNhealthy Substance Use Now Trial
NCT Number: NCT06524232
Acronym: STUN II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Risky Health Behavior|Substance Use Disorders|Substance Abuse|Alcohol Use Disorder|Drinking, Alcohol|Substance Use
Interventions: OTHER: Practice Facilitation (PF)|OTHER: Learning Collaborative (LC)|OTHER: Performance Incentives (PI)
Sponsor: Ohio State University
Collaborators: Ohio Association of Community Health Centers (OACHC)|Bon Secours Mercy Health (BSMH)|Agency for Healthcare Research and Quality (AHRQ)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2027-09
Locations: Bon Secours Mercy Health, Cincinnati, Ohio, 45237, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States|Ohio Association of Community Health Centers, Columbus, Ohio, 43215, United States

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

Primary Outcome Measures: 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 Outcome Measures: Number of adults with a positive screen for substance use disorder, Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result, 12 months|Number of adults with a positive screen for substance use disorder, Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result, 24 months|Percent of adults with a positive screen for substance use disorder, Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result, 12 months|Percent of adults with a positive screen for substance use disorder, Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result, 24 months|Number of adults who received any evidence-based intervention for substance use disorder, 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, 12 months|Number of adults who received any evidence-based intervention for substance use disorder, 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, 24 months|Percentage of adults who received any evidence-based intervention for substance use disorder, 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, 24 months|Percentage of adults who received any evidence-based intervention for substance use disorder, 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, 12 months|Number of adults who received brief counseling for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling, 12 months|Number of adults who received brief counseling for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling, 24 months|Percentage of adults who received brief counseling for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling, 24 months|Percentage of adults who received brief counseling for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling, 12 months|Number of adults who received medication for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication, 12 months|Number of adults who received medication for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication, 24 months|Percentage of adults who received medication for substance use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication, 24 months|Percentage of adults who received medication for substance use disorder, including alcohol use disorder, Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication, 12 months|Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment, 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, 12 months|Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment, 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, 24 months|Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment, 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, 24 months|Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment, 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, 12 months|Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder, 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.), 12 months|Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder, 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.), 24 months|Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder, 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 months|Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder, 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.), 12 months|Number of adults with alcohol use disorder, Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder, 12 months|Number of adults with alcohol use disorder, Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder, 24 months|Percentage of adults with alcohol use disorder, Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder, 24 months|Percentage of adults with alcohol use disorder, Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder, 12 months|Number of adults who received any evidence-based intervention for alcohol use disorder, 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), 12 months|Number of adults who received any evidence-based intervention for alcohol use disorder, 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), 24 months|Percentage of adults who received any evidence-based intervention for alcohol use disorder, 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), 24 months|Percentage of adults who received any evidence-based intervention for alcohol use disorder, 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), 12 months|Number of adults who received brief counseling for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling, 12 months|Number of adults who received brief counseling for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling, 24 months|Percentage of adults who received brief counseling for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling, 24 months|Percentage of adults who received brief counseling for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling, 12 months|Number of adults who received medication for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, number who received medication, 12 months|Number of adults who received medication for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, number who received medication, 24 months|Percentage of adults who received medication for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication, 24 months|Percentage of adults who received medication for alcohol use disorder, Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication, 12 months|Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment, Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months, 12 months|Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment, Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months, 24 months|Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment, Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months, 24 months|Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment, Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months, 12 months|Number of adults referred to specialty care for alcohol use disorder, 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.), 12 months|Number of adults referred to specialty care for alcohol use disorder, 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.), 24 months|Percentage of adults referred to specialty care for alcohol use disorder, 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.), 24 months|Percentage of adults referred to specialty care for alcohol use disorder, 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.), 12 months|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, 24 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, 24 months
Other Outcome Measures: Association between implementation effectiveness and putative moderators and mediators, 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), 12 months|Association between implementation effectiveness and putative moderators and mediators, 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), 24 months