CClinicalTrials.gg
CompletedNCT04565899Updated Apr 20, 2026

Improving Care for Unhealthy Alcohol Use in Primary Care

An interventional study of Practice facilitation implementation intervention in Alcohol Drinking and Alcohol Use Disorder, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

Read the detailed description

Alcohol use is a significant risk factor of disability and death for U.S. adults and one out of every six Veterans seen in primary care report unhealthy alcohol use. Based on substantial evidence from randomized controlled trials and the U.S. Preventive Services Task Force, VA/DoD clinical guidelines stipulate that all Veterans screening positive for unhealthy alcohol use should receive evidence-based alcohol care in primary care, including brief counseling interventions (BI) and additional treatment (e.g., pharmacotherapy) for those with alcohol use disorders (AUD). The VA was a pioneer in implementing alcohol screening and BI in primary care, yet substantial implementation gaps remain. In order to improve the quality and fidelity of alcohol-related care, the current research proposes to use an evidence-based implementation strategy, practice facilitation, at one VA to pilot test whether practice facilitation has the potential to improve quality of primary care-based alcohol-related care.

The project will first conduct qualitative interviews assessing Veteran and clinical stakeholders to understand barriers and facilitators to high-quality alcohol care. Results from qualitative interviews will be used to refine and hone the practice facilitation intervention. Clinical stakeholders will then be recruited to participate in focus groups in order to evaluate the acceptability and feasibility of the proposed practice facilitation intervention prior to testing it. Last, a pilot test of the practice facilitation intervention will be conducted within one VA primary care clinic to understand whether practice facilitation improves the quality of primary care-based alcohol-related care.

02

Conditions studied

  • Alcohol Drinking
  • Alcohol Use Disorder

Keywords

  • Unhealthy alcohol use
  • Alcohol misuse
  • Alcohol use disorder
  • Alcohol abuse
  • Alcohol dependence
  • Binge drinking
  • alcohol drinking
03

Who can participate

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

Inclusion criteria

Veteran patients:

  • Veteran presenting for care at VA primary care site during pilot testing of the practice facilitation intervention, AND
  • Age 18 years and older.

Primary care providers:

  • Primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week.

Exclusion criteria

Exclusion Criteria:

  • None.
04

Study design

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

Study arms

  • Experimental
    Practice facilitation implementation intervention

    6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.

    Other: Practice facilitation implementation intervention

Interventions

  • OtherPractice facilitation implementation intervention

    6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.

05

What researchers measure

Primary outcomes

  1. Reach of alcohol-related care via electronic health record change

    Reach outcomes will be expressed as a rate, with the denominator (for all outcomes) defined as all Veterans with a visit to the primary care site during active implementation of the practice facilitation pilot test. The numerator for each Reach outcome is as follows: the number of Veterans who screened positive for unhealthy alcohol use (AUDIT-C \>= 5) AND had any documented brief intervention, specialty addictions treatment (inpatient and outpatient clinic visits for substance use disorder treatment encounters with an accompanying AUD diagnosis), or pharmacotherapy for AUD (any filled prescription for FDA-approved medications: acamprosate, disulfiram, or oral/injectable naltrexone) in the 30 days following a positive screen. Rates at the start of active implementation and at 3- and 6-months post Active Implementation will be calculated to examine change in Reach outcomes over time.

    Time frame: 3- and 6-months post implementation intervention

  2. Adoption of alcohol-related care via electronic health record change

    Adoption outcomes will be identified as the percentage of providers from the primary care clinic who deliver alcohol-related care when a Veteran screens positive for unhealthy alcohol use (e.g., delivery of brief interventions, consults to specialty addictions treatment, providing pharmacotherapy for AUDs). Rates of alcohol-related care at the start of active implementation and at 3- and 6-months post active implementation will be used to measure whether adoption rates of alcohol-related care increased over time.

    Time frame: 3- and 6-months post implementation intervention

  3. Adoption of alcohol related care via self-report change

    Brief self-report questions to determine whether providers have adopted the suggested evidence-based components of alcohol-related care (e.g., shared decision making, patient-centered discussions, setting goals with patients) will be administered at the start of the active implementation phase, at the end of the active implementation phase, and 3- and 6-months post practice facilitation.

    Time frame: 3- and 6-months post implementation intervention

  4. Maintenance of alcohol-related care via electronic health record

    Reach and Adoption outcomes using electronic health record data will be assessed again at 12-months post active implementation to examine whether high-quality alcohol care was sustained after practice facilitation.

    Time frame: 12-months post implementation intervention

Secondary outcomes

  1. Clinical Effectiveness via electronic health record

    Examine whether Veterans' with an encounter in primary care during active implementation reduced their drinking 12-months post Active Implementation using AUDIT-C scores.

    Time frame: 12-months post implementation intervention

06

Study locations

2 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
    Ann Arbor, Michigan 48105-2303, United States
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
07

References and documents

Publications

  • Bachrach RL, Chinman M, Rodriguez KL, Mor MK, Kraemer KL, Garfunkel CE, Williams EC. Using practice facilitation to improve alcohol-related care in primary care: a mixed-methods pilot study protocol. Addict Sci Clin Pract. 2022 Mar 14;17(1):19. doi: 10.1186/s13722-022-00300-x. PubMed 35287714 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 21, 2023
  • Informed consent form · Jan 6, 2021

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

Individual participant data

Plan to share: Yes — Final data sets underlying publications resulting from the proposed research may be shared.

08

Registry details

Key details

Study ID
NCT04565899
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Feb 25, 2021
Primary completion
Dec 31, 2024
Completion
May 1, 2025
Last update
Apr 20, 2026

Study contacts

Rachel L. Bachrach, PhD MS
principal investigator · VA Ann Arbor Healthcare System, Ann Arbor, MI
Emily C. Williams, PhD MPH
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

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

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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