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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Unhealthy Alcohol Use
• Interventions: Behavioral: Centralized Intervention; Other: Primary Care Intervention

• Registration Number: NCT06318026
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Study Start: 2025-03-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Adult primary care patients ≥18 years old on the day of a primary care appointment; and
2. ≥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
3. 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Centralized Intervention	Centralized Intervention	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.
Primary Care Intervention	Primary Care Intervention	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kaiser Permanente Washington; 🇺🇸 Seattle, Washington, United States