Recruiting

Patient-centered Care

Sponsor:

Kaiser Permanente

Code:

NCT06318026

Conditions

Alcohol Use Disorder

Unhealthy Alcohol Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Centralized Intervention

Primary Care Intervention

Study Details

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

Study ID

NCT06318026

Start date

Mar 25, 2025

Status verified date

May, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: Usual Care

Usual primary care

Interventions

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

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 measure

  • Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims). [ Time Frame: Treatment initiated up to 12 months. ]
  • Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire. [ Time Frame: Up to 24 months. ]

Central Contacts and Locations

Central contacts

Katharine Bradley, MD, MPH

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

Megan Addis

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

Locations

Kaiser Permanente Washington

Recruiting

Seattle, Washington, United States, 98112

Contacts

Megan Addis

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

More Information

Sponsor

Kaiser Permanente

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-05-06.