Clinical trial NCT04317989: STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care
Official title: The STUN (STop UNhealthy) Alcohol Use Now! Project: Using Practice Facilitation to Disseminate and Implement Patient-Centered Outcomes Research (PCOR) Evidence on Screening and Management of Unhealthy Alcohol Use in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risky Health Behavior
Drinking, Alcohol
Alcohol Use Disorder
Drinking, Binge
Drinking Excessive
Keywords: Alcohol, Screening, Counseling, Primary Care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-03-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This trial will evaluate the effect of primary care practice facilitation on evidence-based screening, counseling, and Medication-Assisted Treatment (MAT). Practices are considered the participants; the intervention is conducted on the practice level. All enrolled practices receive the practice facilitation intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. The original recruitment goal was 135 primary care practices in North Carolina, which we were unable to meet due to pandemic-related barriers.

Detailed description: STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation or PF) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. 135 primary care practices in North Carolina will be recruited.

Specific Aim 1 will evaluate the effect of PF on uptake of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use. The investigators hypothesize that PF will increase screening for unhealthy alcohol use and provision of brief counseling. The secondary hypothesis is that practice-level and contextual factors (capacity for quality improvement, organizational readiness to implement change, and implementation climate) will moderate the effect of PF on use of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use.

Specific Aim 2 will evaluate whether PF increases provision, among those identified as having an alcohol use disorder (AUD), provision of medication assisted treatment (MAT) or referral to specialty care.

Aim 3 (effect of providing embedded telehealth services) will not be evaluated due to lower enrollment than anticipated and delayed data collection (both related to the COVID-19 pandemic) which have prevented randomization among practices with slower uptake of SBI after 6 months of PF.

In Aim 4 the investigators will evaluate the effect of PF on the implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The primary hypothesis is that PF will increase implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The secondary hypotheses are that (a) practice capacity for quality improvement (QI), organizational readiness to implement change, and contextual factors will moderate the effect of PF on the implementation of clinical practice and office systems changes and (b) embedded telehealth services will increase implementation of clinical practice and office systems changes among practices with slower uptake.

Eligibility criteria: Inclusion Criteria:

* Small-to-medium sized primary care practices (10 or fewer providers) in North Carolina

Exclusion Criteria:

* Practices with fewer than 100 adult patients (18+ years) or more than 10 providers;
* practices unwilling to implement evidence-based screening and management of patients with unhealthy alcohol use.

Primary outcomes:
measure: Number of adults screened for unhealthy alcohol use
timeFrame: 18 months
measure: Number of adults screened for unhealthy alcohol use
timeFrame: 12 months
measure: Number of adults screened for unhealthy alcohol use
timeFrame: 6 months
measure: Percent of adults screened for unhealthy alcohol use
timeFrame: 18 months
measure: Percent of adults screened for unhealthy alcohol use
timeFrame: 12 months
measure: Percent of adults screened for unhealthy alcohol use
timeFrame: 6 months
Secondary outcomes:
measure: Number of adults with a positive screen for unhealthy alcohol use
timeFrame: 18 months
measure: Number of adults with a positive screen for unhealthy alcohol use
timeFrame: 12 months
measure: Number of adults with a positive screen for unhealthy alcohol use
timeFrame: 6 months
measure: Percent of adults with a positive screen for unhealthy alcohol use
timeFrame: 18 months
measure: Percent of adults with a positive screen for unhealthy alcohol use
timeFrame: 12 months
measure: Percent of adults with a positive screen for unhealthy alcohol use
timeFrame: 6 months
measure: Number of adults provided with brief counseling for risky drinking
timeFrame: 18 months
measure: Number of adults provided with brief counseling for risky drinking
timeFrame: 12 months
measure: Number of adults provided with brief counseling for risky drinking
timeFrame: 6 months
measure: Percent of adults provided with brief counseling for risky drinking
timeFrame: 18 months
measure: Percent of adults provided with brief counseling for risky drinking
timeFrame: 12 months
measure: Percent of adults provided with brief counseling for risky drinking
timeFrame: 6 months
measure: Number of adults identified as having alcohol use disorder (AUD)
timeFrame: 18 months
measure: Number of adults identified as having alcohol use disorder (AUD)
timeFrame: 12 months
measure: Number of adults identified as having alcohol use disorder (AUD)
timeFrame: 6 months
measure: Percent of adults identified as having alcohol use disorder (AUD)
timeFrame: 18 months
measure: Percent of adults identified as having alcohol use disorder (AUD)
timeFrame: 12 months
measure: Percent of adults identified as having alcohol use disorder (AUD)
timeFrame: 6 months
measure: Number of adults prescribed pharmacotherapy for AUD
timeFrame: 18 months
measure: Number of adults prescribed pharmacotherapy for AUD
timeFrame: 12 months
measure: Number of adults prescribed pharmacotherapy for AUD
timeFrame: 6 months
measure: Percent of adults with AUD who were prescribed pharmacotherapy for AUD
timeFrame: 18 months
measure: Percent of adults with AUD who were prescribed pharmacotherapy for AUD
timeFrame: 12 months
measure: Percent of adults with AUD who were prescribed pharmacotherapy for AUD
timeFrame: 6 months
measure: Number of adults with AUD referred to specialty care for AUD
timeFrame: 18 months
measure: Number of adults with AUD referred to specialty care for AUD
timeFrame: 12 months
measure: Number of adults with AUD referred to specialty care for AUD
timeFrame: 6 months
measure: Percent of adults with AUD referred to specialty care for AUD
timeFrame: 18 months
measure: Percent of adults with AUD referred to specialty care for AUD
timeFrame: 12 months
measure: Percent of adults with AUD referred to specialty care for AUD
timeFrame: 6 months
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mountain AHEC
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte AHEC
state: North Carolina
city: Greensboro
country: United States
facility: Greensboro AHEC
state: North Carolina
city: Greenville
country: United States
facility: Eastern AHEC
state: North Carolina
city: Raleigh
country: United States
facility: Wake AHEC
state: North Carolina
city: Rocky Mount
country: United States
facility: Area L AHEC
state: North Carolina
city: Wilmington
country: United States
facility: Southeast AHEC
state: North Carolina
Study officials:
affiliation: Ohio State University
name: Daniel E Jonas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Darren Dewalt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonas DE, Barclay C, Grammer D, Weathington C, Birken SA, DeWalt DA, Shoenbill KA, Boynton MH, Mackey M, Riley S, Cykert S. The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care. Trials. 2021 Nov 16;22(1):810. doi: 10.1186/s13063-021-05641-7.