STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care

Not Applicable

Completed

• Conditions: Alcohol Use Disorder; Risky Health Behavior; Drinking, Binge; Drinking Excessive; Drinking, Alcohol
• Interventions: Other: Practice Facilitation

• Registration Number: NCT04317989
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-23
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Practice Facilitation	Practice Facilitation	All enrolled practices will receive practice facilitation for the duration of the intervention period.

Primary Outcome Measures

Name	Time	Method
Percent of adults screened for unhealthy alcohol use	6 months	percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Number of adults screened for unhealthy alcohol use	6 months	number aged 18 or older who were screened with a validated tool for unhealthy alcohol use

Secondary Outcome Measures

Name	Time	Method
Percent of adults with a positive screen for unhealthy alcohol use	6 months	Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Number of adults with a positive screen for unhealthy alcohol use	6 months	Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Percent of adults with AUD who were prescribed pharmacotherapy for AUD	6 months	After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Number of adults provided with brief counseling for risky drinking	6 months	Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Percent of adults provided with brief counseling for risky drinking	6 months	Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Number of adults identified as having alcohol use disorder (AUD)	6 months	After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Percent of adults identified as having alcohol use disorder (AUD)	6 months	After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Number of adults with AUD referred to specialty care for AUD	6 months	After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Number of adults prescribed pharmacotherapy for AUD	6 months	After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Percent of adults with AUD referred to specialty care for AUD	6 months	After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)

Trial Locations

Locations (7)

Area L AHEC; 🇺🇸 Rocky Mount, North Carolina, United States

Southeast AHEC; 🇺🇸 Wilmington, North Carolina, United States

Greensboro AHEC; 🇺🇸 Greensboro, North Carolina, United States

Charlotte AHEC; 🇺🇸 Charlotte, North Carolina, United States

Mountain AHEC; 🇺🇸 Asheville, North Carolina, United States

Wake AHEC; 🇺🇸 Raleigh, North Carolina, United States

Eastern AHEC; 🇺🇸 Greenville, North Carolina, United States