Improving Care for Unhealthy Alcohol Use in Primary Care

NCT ID: NCT04565899

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2025-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Alcohol Drinking Alcohol Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot trial of an implementation strategy within one primary care clinic where all providers will be invited to participate
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Practice facilitation implementation intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel L. Bachrach, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Emily C. Williams, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35287714 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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K2HX003087

Identifier Type: OTHER

Identifier Source: secondary_id

CDX 21-001

Identifier Type: -

Identifier Source: org_study_id

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