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Risky Health BehaviorSTUNNCT04317989

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

A study testing Practice Facilitation in people with Risky Health Behavior and Drinking, Alcohol, run by University of North Carolina, Chapel Hill at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Practice Facilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
7 sitesUnited States
Study dates
22 Jan 2020to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Mountain AHEC

    Asheville, North Carolina, 28803-2868

  • Charlotte AHEC

    Charlotte, North Carolina, 28232

  • Greensboro AHEC

    Greensboro, North Carolina, 27401

  • Eastern AHEC

    Greenville, North Carolina, 27835

  • Wake AHEC

    Raleigh, North Carolina, 27604-1657

  • Area L AHEC

    Rocky Mount, North Carolina, 27804-0368

  • Southeast AHEC

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

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

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.

Being tested
Practice Facilitation
Keywords
Alcohol, Screening, Counseling, Primary Care
Medical subject headings
Health Risk Behaviors, Alcohol Drinking, Alcoholism, Binge Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Practice FacilitationOther

    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.
Study groups in NCT04317989
Study groupRoleWhat they receive
Practice FacilitationExperimentalAll enrolled practices will receive practice facilitation for the duration of the intervention period.
Receives: Other: Practice Facilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 6 months

Secondary outcomes (30)
  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start22 Jan 2020
  3. Primary completion30 Jun 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317989
Sponsor's protocol ID
19-1853
Other IDs
1R18HS027078-01
Acronym
STUN
Status last verified
Nov 2023
First submitted
16 Mar 2020
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Practice Facilitation in people with Risky Health Behavior and Drinking, Alcohol, run by University of North Carolina, Chapel Hill at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adults screened for unhealthy alcohol use (time frame: 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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