Screening and Management of Unhealthy Alcohol Use in Primary Care

Alcohol Use Disorder Clinical Trial

Official title:

Practice Facilitation to Promote Evidence-based Screening and Management of Unhealthy Alcohol Use in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248023
• Other study ID #: HM20016728
• Secondary ID: 1R18HS027077-01
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unhealthy alcohol use is the third leading preventable cause of death in the United States. Yet, primary care physicians do not, on average, screen for and address unhealthy alcohol use in their patient populations. By implementing practice changes to promote screening and treatment, patients stand to reduce unhealthy alcohol use and benefit from improved health outcomes. This project will provide a sample of Virginia primary care practices with a practice facilitator, practice specific resources, education on screening and counseling, and education on medication assisted therapy. The project will measure whether this change will improve screening rates and promote reduction of unhealthy alcohol use.

Description:

Unhealthy alcohol use is the third leading cause of preventable death in the US. Evidence shows that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral counseling interventions improves health outcomes, collectively termed screening and brief intervention (SBI). For moderate or severe alcohol use disorder (AUD), medication assistance therapy (MAT) is effective. Despite clear evidence of effectiveness, only 13% of primary care patients are screened with a standard instrument and only 6.7% of adults with AUD receive treatment. We believe that underutilization of SBI and MAT are driven by both a misunderstanding of the role and effectiveness of primary care in addressing unhealthy alcohol and limited practice resource and infrastructure. To promote the dissemination and implementation of evidence-based strategies to address unhealthy alcohol use throughout Virginia, we have extended our EvidenceNow collaboration to include addiction medicine experts at Virginia Commonwealth University, the Virginia Ambulatory Care Outcomes Research Network (ACORN), our state's family medicine residency training programs, and our state's Community Service Boards. We propose a practice-level cluster randomized trial with wait list control. 125 primary care practices in five regions throughout the state, each centered around a residency site for educational support, will receive a practice facilitation intervention to implement screening, counseling, and treatment for unhealthy alcohol at intervention start or 6-month delay. Guided by the identified EvidenceNow key drivers for change, practice support will include practice facilitation, education and training, shared learning and best practices, screening and counseling toolkits, data support, and assessment with feedback. Each practice will identify a clinician, nurse, and administrator champion to locally lead efforts and participate in learning collaboratives. Practices will design and implement screening, counseling, and treatment processes and operational changes, adapting their implementation strategy based on experiences and findings from other sites. We will conduct a mixed methods analysis. Primary outcomes will include the increase in screening for unhealthy alcohol use, increase in provision of brief counseling interventions and MAT, and reduction in alcohol intake for patients after practices receive practice facilitation. We will use the consolidated framework for implementation research to code and rate practice facilitation (e.g. dose, mode, reach) and practice implementation strategies (e.g. SBI and MAT strategies and tools implemented) on outcomes. Data sources will include practice facilitator field notes and interviews, chart reviews, patient survey, clinician survey, All Payer Claims Data, and qualitative interviews. We will administer the patient survey at baseline, 3 months, and 6 months after the intervention. Among patients age 18 to 75 with an office visit the prior month, we will randomly select 60 to survey. In addition to our internal evaluation, we will participate in the external collaborative evaluation and dissemination activities with AHRQ throughout the project.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13680
• Est. completion date: May 31, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Practice Inclusion Criteria:

1. Primary care practices

2. Ambulatory care practices

Patient Inclusion Criteria:

1. Patients 18 years and older and with an office visit at an included study site

Practice Exclusion Criteria:

1. Practices that do not provide outpatient care

2. Practices that do not provide primary care

Patient Exclusion Criteria:

1. Patients under 18 years old

2. Patients without an office visit

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Practice Facilitation
A practice facilitator will be assigned the each participating practice to assist with the development of a workflow, screening process, counseling resources, and referral resources for unhealthy alcohol use. Practices in control group will receive delayed intervention at 3 months after their matched cohort of practices.

Locations

Country	Name	City	State
United States	Virginia Ambulatory Care Outcomes Research Network	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening for Unhealthy Alcohol Use	This outcome will evaluate the percent of patients who were screened in clinic or report screening for alcohol use (numerator = intervention patients sampled who received counseling/ denominator = intervention patients who did not receive counseling at 3 time points.)	6 months
Primary	Treatment for Unhealthy Alcohol Use	This outcome will measure the percent of patients, screening positive for risky alcohol use, that receive any type of treatment including, but not limited to, counseling, brief intervention, motivational interviewing, referral, or medication assisted treatment.	6 months
Secondary	Reduction of Unhealthy Alcohol Use	This measure will identify the percent of patients with unhealthy alcohol use that have reduced alcohol intake after practice facilitation (numerator = number of sample patients with unhealthy alcohol use at baseline that received treatment / denominator = number of patients with unhealthy alcohol use at baseline.)	6 months