NCT04317989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

June 17, 2025

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

March 16, 2020

Last Update Submit

June 16, 2025

Conditions

Keywords

Alcohol, Screening, Counseling, Primary Care

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (30)

  • Number of adults with a positive screen for unhealthy alcohol use

    18 months

  • Number of adults with a positive screen for unhealthy alcohol use

    12 months

  • Number of adults with a positive screen for unhealthy alcohol use

    6 months

  • Percent of adults with a positive screen for unhealthy alcohol use

    18 months

  • Percent of adults with a positive screen for unhealthy alcohol use

    12 months

  • +25 more secondary outcomes

Study Arms (1)

Practice Facilitation

EXPERIMENTAL

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

Other: Practice Facilitation

Interventions

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.

Practice Facilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mountain AHEC

Asheville, North Carolina, 28803-2868, United States

Location

Charlotte AHEC

Charlotte, North Carolina, 28232, United States

Location

Greensboro AHEC

Greensboro, North Carolina, 27401, United States

Location

Eastern AHEC

Greenville, North Carolina, 27835, United States

Location

Wake AHEC

Raleigh, North Carolina, 27604-1657, United States

Location

Area L AHEC

Rocky Mount, North Carolina, 27804-0368, United States

Location

Southeast AHEC

Wilmington, North Carolina, 28403, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health Risk BehaviorsAlcohol DrinkingAlcoholismBinge Drinking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDrinking BehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Daniel E Jonas, MD, MPH

    Ohio State University

    PRINCIPAL INVESTIGATOR
  • Darren Dewalt, MD, MPH

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 23, 2020

Study Start

January 22, 2020

Primary Completion

June 30, 2023

Study Completion

October 31, 2023

Last Updated

June 17, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations