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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06318026
Other study ID # R01AA031231
Secondary ID R01AA031231
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date February 2029

Study information

Verified date March 2024
Source Kaiser Permanente
Contact Katharine Bradley, MD, MPH
Phone 206-948-1933
Email Katharine.A.Bradley@kp.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions 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 30 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date February 2029
Est. primary completion date February 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult primary care patients (>=18 years old on the day of a primary care visit); 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, on the day of the primary care visit or the prior 30 days documented in the electronic health record; and 3. high-risk drinking on alcohol screening questionnaire (AUDIT-C >=7) on the day of the primary care visit or in the prior 30 days documented in the electronic health record. Exclusion Criteria: Documented request to not participate in research.

Study Design


Intervention

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.

Locations

Country Name City State
United States Kaiser Permanente Washington Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Kaiser Permanente Kaiser Permanente Washington, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims). Treatment initiated up to 12 months.
Primary Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire. Up to 24 months.
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