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

Kaiser Permanente

Status: Enrolling

Conditions: Unhealthy Alcohol Use; Alcohol Use Disorder

Treatments: Other: Primary Care Intervention; Behavioral: Centralized Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06318026

R01AA031231 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Centralized Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Centralized Intervention

Primary Care Intervention

Experimental group

Description:

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.

Treatment:

Other: Primary Care Intervention

Usual Care

No Intervention group

Description:

Usual primary care