Screening and Management of Unhealthy Alcohol Use in Primary Care

NCT04248023 | Completed

• 2 other identifiers: HM200167281R18HS027077-01
• Study Type: interventional
• Target: 13,680
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alcohol Drinking; Alcohol Abuse; Alcohol Use Disorder

Keywords

Alcohol Misuse; Alcohol Abuse; Practice Facilitation; Motivational Interviewing; Preventive Services

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Reduction of Unhealthy Alcohol Use

  6 months

Study Arms (2)

Intervention Practices

EXPERIMENTAL

Intervention practices will work with a practice facilitator to make practice specific changes to address unhealthy alcohol use.

Behavioral: Practice Facilitation

Control Practices

NO INTERVENTION

Control practices will continue to screening and address unhealthy alcohol use based on their existing practice patterns.

Interventions

Practice Facilitation BEHAVIORAL

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.

Intervention Practices

Eligibility Criteria

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

You may qualify if:

• Primary care practices
• Ambulatory care practices
• \. Patients 18 years and older and with an office visit at an included study site

You may not qualify if:

• Practices that do not provide outpatient care
• Practices that do not provide primary care
• Patients under 18 years old
• Patients without an office visit

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Virginia Ambulatory Care Outcomes Research Network

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Huffstetler AN, Villalobos G, Webel B, Rockwell MS, Funk A, Sabo RT, Epling JW, Brooks EM, Britz JB, Bortz BA, Svikis DS, Arias AJ, Tran RN, Krist AH. Practice Facilitation to Address Unhealthy Alcohol Use in Primary Care: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Aug 2;5(8):e242371. doi: 10.1001/jamahealthforum.2024.2371.

  PMID: 39120895 DERIVED

• Huffstetler AN, Kuzel AJ, Sabo RT, Richards A, Brooks EM, Lail Kashiri P, Villalobos G, Arias AJ, Svikis D, Bortz BA, Edwards A, Epling J, Cohen DJ, Parchman ML, Winter J, Wessler P, Yu TJ, Krist AH. Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial. BMC Fam Pract. 2020 May 20;21(1):93. doi: 10.1186/s12875-020-01147-4.

  PMID: 32434467 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander H Krist, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Based on the intervention of practice facilitation, it is not able to blind practices or clinicians from the intervention.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a practice level randomized controlled trial. 125 practices across Virginia will receive the intervention (practice facilitation to enhance screening and treatment of unhealthy alcohol use (UAU)) or act as a control group (will receive practice facilitation at 3 month lag behind intervention groups.) The investigators will survey 60 patients from each practice at three time intervals to evaluate the current state and what changes are implemented and reported over the course of the study. An additional 60 patient chart review from each practice will be preformed. The investigators will use an implementation-effectiveness design to measure outcomes. Effectiveness outcomes include increased screening rate of patients; increased treatment of any kind for patients with UAU; and reduction of UAU. Implementation outcomes will include the barriers and facilitators to screening and evaluating for UAU.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: July 15, 2020
• Primary Completion: July 30, 2022
• Study Completion: May 31, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

US (2)