Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment

NCT06318026 | Recruiting

• 1 other identifier: R01AA031231
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions in Kaiser Permanente Washington to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 25 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.

Conditions

Alcohol Use Disorder; Unhealthy Alcohol Use

Keywords

Patient-centered care; Shared decision-making; Population-based management; Quality improvement; Decision aid

Outcome Measures

Primary Outcomes (2)

• Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims).

  Treatment initiated up to 12 months.

• Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire.

  Up to 24 months.

Study Arms (3)

Centralized Intervention

EXPERIMENTAL

A centralized intervention by a social worker or counselor, added to usual care that systematically offers outreach and shared decision-making for symptoms due to alcohol use.

Behavioral: Centralized Intervention

Primary Care Intervention

EXPERIMENTAL

A primary care intervention added to usual care that uses state-of-the-art implementation interventions to systematically encourage primary care providers to offer routine shared decision-making for symptoms due to alcohol use.

Other: Primary Care Intervention

Usual Care

NO INTERVENTION

Usual primary care

Interventions

Centralized Intervention BEHAVIORAL

A centralized intervention by a social worker or counselor, added to usual care that systematically offers outreach and shared decision-making for symptoms due to alcohol use

Centralized Intervention

Primary Care Intervention OTHER

A primary care intervention added to usual care that uses state-of-the-art implementation interventions to systematically encourage primary care providers to offer routine shared decision-making for symptoms due to alcohol use.

Primary Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult primary care patients ≥18 years old on the day of a primary care appointment; and
• ≥4 symptoms on the Alcohol Symptom Checklist, or 2-3 symptoms on the Alcohol Symptom Checklist with at least one symptom associated with high risk of progression to severe symptoms, documented in the electronic health record associated with the primary care appointment; and
• high-risk drinking on the alcohol screening questionnaire (AUDIT-C ≥7) on the day of the Alcohol Symptom Checklist or in the prior 30 days documented in the electronic health record.

You may not qualify if:

• Documented request to not participate in research, or
• Patient was eligible for the Vanguard pilot study.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of Washington: collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

• Katharine Bradley, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Gwen Lapham, PhD, MPH, MSW

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Bradley, MD, MPH

CONTACT

206-948-1933; Katharine.A.Bradley@kp.org

Megan Addis

CONTACT

206-287-2052; Megan.J.Addis@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: EHR and survey (latter masked)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 19, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)