Clinical trial NCT04565899: Improving Care for Unhealthy Alcohol Use in Primary Care
Official title: Implementation Intervention to Improve Care for Unhealthy Alcohol Use (CDA 20-057)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Alcohol Use Disorder
Keywords: Unhealthy alcohol use
Alcohol misuse
Alcohol use disorder
Alcohol abuse
Alcohol dependence
Binge drinking
alcohol drinking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot trial of an implementation strategy within one primary care clinic where all providers will be invited to participate
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reach of alcohol-related care via electronic health record change
timeFrame: 3- and 6-months post implementation intervention
measure: Adoption of alcohol-related care via electronic health record change
timeFrame: 3- and 6-months post implementation intervention
measure: Adoption of alcohol related care via self-report change
timeFrame: 3- and 6-months post implementation intervention
measure: Maintenance of alcohol-related care via electronic health record
timeFrame: 12-months post implementation intervention
Secondary outcomes:
measure: Clinical Effectiveness via electronic health record
timeFrame: 12-months post implementation intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Rachel L. Bachrach, PhD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Emily C. Williams, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.