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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318026
Enrollment
1500
Registered
2024-03-19
Start date
2025-03-25
Completion date
2029-02-28
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Unhealthy Alcohol Use

Keywords

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

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.

Interventions

BEHAVIORALCentralized 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

OTHERPrimary 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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Washington
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

EHR and survey (latter masked)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

United States

Contacts

Primary ContactKatharine Bradley, MD, MPH
Katharine.A.Bradley@kp.org206-948-1933
Backup ContactMegan Addis
Megan.J.Addis@kp.org206-287-2052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026