Improving Care for Unhealthy Alcohol Use in Primary Care

Alcohol Use Disorder Clinical Trial

Official title:

Implementation Intervention to Improve Care for Unhealthy Alcohol Use (CDA 20-057)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04565899
• Other study ID #: CDX 21-001
• Secondary ID: K2HX003087
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: September 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	12-months post implementation intervention