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

Alcohol Use Disorder Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Unhealthy Alcohol Use

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.