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Recruiting NCT06318026

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

No phase Interventional Alcohol Use Disorder Unhealthy Alcohol Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Centralized Intervention, Primary Care Intervention.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Unhealthy Alcohol Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral 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
  • Other 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

  • 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.]

Eligibility criteria

Inclusion criteria

  • Adult primary care patients ≥18 years old on the day of a primary care appointment; and
  • ≥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
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Kaiser Permanente Washington — Seattle

Identifiers

NCT: NCT06318026 · R01AA031231 · R01AA031231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗