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

NCT ID: NCT04317989

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2023-10-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Practice Facilitation

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

Group Type: EXPERIMENTAL

Practice Facilitation

Intervention Type: OTHER

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.

Interventions

Practice 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel E Jonas, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Darren Dewalt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34784953 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R18HS027078-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

19-1853

Identifier Type: -

Identifier Source: org_study_id