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

March 18, 2024 updated by: Kaiser Permanente
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98112
        • Kaiser Permanente Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Experimental: 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.
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.
No Intervention: Usual Care
Usual primary care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

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

Investigators

  • Principal Investigator: Katharine Bradley, MD, MPH, Kaiser Permanente
  • Principal Investigator: Gwen Lapham, PhD, MPH, MSW, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AA031231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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