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

NCT ID: NCT06318026

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2029-02-28

Brief Summary

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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

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Conditions

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Alcohol Use Disorder Unhealthy Alcohol Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
EHR and survey (latter masked)

Study Groups

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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.

Group Type EXPERIMENTAL

Centralized Intervention

Intervention Type 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

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.

Group Type EXPERIMENTAL

Primary Care Intervention

Intervention Type 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.

Usual Care

Usual primary care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katharine Bradley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Gwen Lapham, PhD, MPH, MSW

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katharine Bradley, MD, MPH

Role: CONTACT

206-948-1933

Megan Addis

Role: CONTACT

206-287-2052

Facility Contacts

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Megan Addis

Role: primary

206-287-2052

Other Identifiers

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R01AA031231

Identifier Type: NIH

Identifier Source: secondary_id

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R01AA031231

Identifier Type: NIH

Identifier Source: org_study_id

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