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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Drinking, Alcohol; Drinking Excessive; Risky Health Behavior; Drinking, Binge
• Intervention / Treatment: Other: Practice Facilitation

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28803-2868
      • Mountain AHEC
    • Charlotte, North Carolina, United States, 28232
      • Charlotte AHEC
    • Greensboro, North Carolina, United States, 27401
      • Greensboro AHEC
    • Greenville, North Carolina, United States, 27835
      • Eastern AHEC
    • Raleigh, North Carolina, United States, 27604-1657
      • Wake AHEC
    • Rocky Mount, North Carolina, United States, 27804-0368
      • Area L AHEC
    • Wilmington, North Carolina, United States, 28403
      • Southeast AHEC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Practice Facilitation; All enrolled practices will receive practice facilitation for the duration of the intervention period.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Daniel E Jonas, MD, MPH, Ohio State University; Principal Investigator: Darren Dewalt, MD, MPH, UNC Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Alcohol, Screening, Counseling, Primary Care
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Binge Drinking
• Other Study ID Numbers: 19-1853; 1R18HS027078-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No