Improving Care for Unhealthy Alcohol Use in Primary Care

NCT04565899 | Completed

• 2 other identifiers: CDX 21-001K2HX003087
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Alcohol Drinking; Alcohol Use Disorder

Keywords

Unhealthy alcohol use; Alcohol misuse; Alcohol use disorder; Alcohol abuse; Alcohol dependence; Binge drinking; alcohol drinking

Outcome Measures

Primary Outcomes (4)

• 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.

  3- and 6-months post implementation intervention

• 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.

  3- and 6-months post implementation intervention

• 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.

  3- and 6-months post implementation intervention

• 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.

  12-months post implementation intervention

Secondary Outcomes (1)

• Clinical Effectiveness via electronic health record

  12-months post implementation intervention

Study Arms (1)

Practice facilitation implementation intervention

EXPERIMENTAL

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

Practice facilitation implementation intervention OTHER

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.

Practice facilitation implementation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

• 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.

  PMID: 35287714 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Binge Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rachel L. Bachrach, PhD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Emily C. Williams, PhD MPH

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Pilot trial of an implementation strategy within one primary care clinic where all providers will be invited to participate

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 25, 2020
• Study Start: February 25, 2021
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After Oct. 1, 2025
• Access Criteria: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The limited dataset will be made available following written (email) request to the PI.

Locations

US (2)