Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Documented request to not participate in research, or
Patient was eligible for the Vanguard pilot study.
Trial design
Design model
Parallel
Treatments tested in this trial
Centralized Intervention
BehavioralA 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 interventionA 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.
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: Centralized InterventionExperimental treatment 1 intervention
Group B: Primary Care InterventionExperimental treatment 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov