CClinicalTrials.gg
CompletedNCT04317989STUNUpdated Jun 17, 2025

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

An interventional study of Practice Facilitation in Risky Health Behavior, Drinking, Alcohol and Alcohol Use Disorder, sponsored by University of North Carolina, Chapel Hill. Completed at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Alcohol, Screening, Counseling, Primary Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Practice Facilitation

    All enrolled practices will receive practice facilitation for the duration of the intervention period.

    Other: Practice Facilitation

Interventions

  • OtherPractice Facilitation

    1. 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. 2. Promoting a strong use of decision support tools and templates to support the practice workflow. 3. Optimizing the use of the electronic health record (EHR) to pull clinical data on a monthly basis to guide the change process. 4. Developing patient registries (e.g., for those identified to have AUD) to identify needed care 5. 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. 6. Enhancing the understanding of available counseling and referral resources to ensure that practices are confident that they have appropriate evidence-based intervention options.

05

What researchers measure

Primary outcomes

  1. Number of adults screened for unhealthy alcohol use

    number aged 18 or older who were screened with a validated tool for unhealthy alcohol use

    Time frame: 18 months

  2. Number of adults screened for unhealthy alcohol use

    number aged 18 or older who were screened with a validated tool for unhealthy alcohol use

    Time frame: 12 months

  3. Number of adults screened for unhealthy alcohol use

    number aged 18 or older who were screened with a validated tool for unhealthy alcohol use

    Time frame: 6 months

  4. 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

    Time frame: 18 months

  5. 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

    Time frame: 12 months

  6. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 18 months

  2. 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

    Time frame: 12 months

  3. 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

    Time frame: 6 months

  4. 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

    Time frame: 18 months

  5. 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

    Time frame: 12 months

  6. 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

    Time frame: 6 months

  7. 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)

    Time frame: 18 months

  8. 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)

    Time frame: 12 months

  9. 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)

    Time frame: 6 months

  10. 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)

    Time frame: 18 months

  11. 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)

    Time frame: 12 months

  12. 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)

    Time frame: 6 months

  13. 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)

    Time frame: 18 months

  14. 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)

    Time frame: 12 months

  15. 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)

    Time frame: 6 months

  16. 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)

    Time frame: 18 months

  17. 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)

    Time frame: 12 months

  18. 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)

    Time frame: 6 months

  19. 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

    Time frame: 18 months

  20. 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

    Time frame: 12 months

  21. 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

    Time frame: 6 months

  22. 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

    Time frame: 18 months

  23. 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

    Time frame: 12 months

  24. 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

    Time frame: 6 months

  25. 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)

    Time frame: 18 months

  26. 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)

    Time frame: 12 months

  27. 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)

    Time frame: 6 months

  28. 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)

    Time frame: 18 months

  29. 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)

    Time frame: 12 months

  30. 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)

    Time frame: 6 months

06

Study locations

7 sites
  • Mountain AHEC
    Asheville, North Carolina 28803-2868, United States
  • Charlotte AHEC
    Charlotte, North Carolina 28232, United States
  • Greensboro AHEC
    Greensboro, North Carolina 27401, United States
  • Eastern AHEC
    Greenville, North Carolina 27835, United States
  • Wake AHEC
    Raleigh, North Carolina 27604-1657, United States
  • Area L AHEC
    Rocky Mount, North Carolina 27804-0368, United States
  • Southeast AHEC
    Wilmington, North Carolina 28403, United States
07

References and documents

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. PubMed 34784953 ↗

Study documents

  • Informed consent form · Dec 11, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04317989
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
Mar 23, 2020
Start date
Jan 22, 2020
Primary completion
Jun 30, 2023
Completion
Oct 31, 2023
Last update
Jun 17, 2025

Study contacts

Daniel E Jonas, MD, MPH
principal investigator · Ohio State University
Darren Dewalt, MD, MPH
principal investigator · UNC Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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