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NCT Number: NCT06318026

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

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.

Recruiting

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Unhealthy Alcohol Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location status: Recruiting

Location contact

Megan Addis

CONTACT

[email protected]

206-287-2052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Centralized Intervention

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

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.

Primary outcomes

  1. Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims).

    Time frame: Treatment initiated up to 12 months.

  2. Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire.

    Time frame: Up to 24 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Katharine Bradley, MD, MPH

CONTACT

[email protected]

206-948-1933

Megan Addis

CONTACT

[email protected]

206-287-2052

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Washington

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 19, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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