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

Alcohol Use Disorder Clinical Trial

— STUN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317989
• Other study ID #: 19-1853
• Secondary ID: 1R18HS027078-01
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Binge Drinking
• Drinking Excessive
• Drinking, Alcohol
• Drinking, Binge
• Risky Health Behavior

Intervention

Other:
• Practice Facilitation
Implementing evidence-based protocols and the use of clinical algorithms (for screening, counseling, referral, and MAT) to engage the entire clinical team in a high standard delivery of care. Promoting a strong use of decision support tools and templates to support the practice workflow. Optimizing the use of the electronic health record (EHR) to pull clinical data on a monthly basis to guide the change process. Developing patient registries (e.g., for those identified to have AUD) to identify needed care Proactive, team-based care with assigned roles and responsibilities to prepare the clinical team to develop needed care and engage patients throughout the entire visit process. Enhancing the understanding of available counseling and referral resources to ensure that practices are confident that they have appropriate evidence-based intervention options.

Locations

Country	Name	City	State
United States	Mountain AHEC	Asheville	North Carolina
United States	Charlotte AHEC	Charlotte	North Carolina
United States	Greensboro AHEC	Greensboro	North Carolina
United States	Eastern AHEC	Greenville	North Carolina
United States	Wake AHEC	Raleigh	North Carolina
United States	Area L AHEC	Rocky Mount	North Carolina
United States	Southeast AHEC	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adults screened for unhealthy alcohol use	number aged 18 or older who were screened with a validated tool for unhealthy alcohol use	18 months
Primary	Number of adults screened for unhealthy alcohol use	number aged 18 or older who were screened with a validated tool for unhealthy alcohol use	12 months
Primary	Number of adults screened for unhealthy alcohol use	number aged 18 or older who were screened with a validated tool for unhealthy alcohol use	6 months
Primary	Percent of adults screened for unhealthy alcohol use	percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use	18 months
Primary	Percent of adults screened for unhealthy alcohol use	percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use	12 months
Primary	Percent of adults screened for unhealthy alcohol use	percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use	6 months
Secondary	Number of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result	18 months
Secondary	Number of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result	12 months
Secondary	Number of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result	6 months
Secondary	Percent of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result	18 months
Secondary	Percent of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result	12 months
Secondary	Percent of adults with a positive screen for unhealthy alcohol use	Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result	6 months
Secondary	Number of adults provided with brief counseling for risky drinking	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)	18 months
Secondary	Number of adults provided with brief counseling for risky drinking	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)	12 months
Secondary	Number of adults provided with brief counseling for risky drinking	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)	6 months
Secondary	Percent of adults provided with brief counseling for risky drinking	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)	18 months
Secondary	Percent of adults provided with brief counseling for risky drinking	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)	12 months
Secondary	Percent of adults provided with brief counseling for risky drinking	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)	6 months
Secondary	Number of adults identified as having alcohol use disorder (AUD)	After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)	18 months
Secondary	Number of adults identified as having alcohol use disorder (AUD)	After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)	12 months
Secondary	Number of adults identified as having alcohol use disorder (AUD)	After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)	6 months
Secondary	Percent of adults identified as having alcohol use disorder (AUD)	After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)	18 months
Secondary	Percent of adults identified as having alcohol use disorder (AUD)	After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)	12 months
Secondary	Percent of adults identified as having alcohol use disorder (AUD)	After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)	6 months
Secondary	Number of adults prescribed pharmacotherapy for AUD	After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	18 months
Secondary	Number of adults prescribed pharmacotherapy for AUD	After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	12 months
Secondary	Number of adults prescribed pharmacotherapy for AUD	After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	6 months
Secondary	Percent of adults with AUD who were prescribed pharmacotherapy for AUD	After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	18 months
Secondary	Percent of adults with AUD who were prescribed pharmacotherapy for AUD	After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	12 months
Secondary	Percent of adults with AUD who were prescribed pharmacotherapy for AUD	After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate	6 months
Secondary	Number of adults with AUD referred to specialty care for AUD	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)	18 months
Secondary	Number of adults with AUD referred to specialty care for AUD	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)	12 months
Secondary	Number of adults with AUD referred to specialty care for AUD	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)	6 months
Secondary	Percent of adults with AUD referred to specialty care for AUD	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)	18 months
Secondary	Percent of adults with AUD referred to specialty care for AUD	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)	12 months
Secondary	Percent of adults with AUD referred to specialty care for AUD	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)	6 months