NCT05252221

Brief Summary

This pragmatic, cluster-randomized trial in adult primary care clinics in a healthcare system with a diverse membership will examine the effectiveness of an innovative, multi-faceted intervention, the Addiction Telemedicine Consultant (ATC) service using clinical pharmacists to facilitate alcohol use problems and alcohol use disorder (AUD) pharmacotherapy and specialty addiction treatment entry.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41,843

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

January 28, 2022

Last Update Submit

April 29, 2024

Conditions

Alcohol Use Disorder (AUD)Pharmacist-Patient RelationsAlcohol Problem

Outcome Measures

Primary Outcomes (8)

  • Implementation Outcomes

    AUD Medication Prescription Rate

    2 years

  • Implementation Outcomes

    Rates of referrals to specialty addiction treatment

    2 years

  • AUD Medication Fills

    AUD Medication Fills

    2 years

  • Addiction Treatment Initiation Rate

    Addiction Treatment Initiation Rate

    2 years

  • Alcohol use (quantity/frequency)

    Alcohol use (quantity/frequency)

    2 years

  • Rates of referral to specialty Addiction Medicine department

    Specialty addiction treatment referrals

    2 years

  • Rates of emergency department utilization in the intervention arms

    Health Service Utilization

    2 years

  • Rates of inpatient services utilization in the intervention arms

    Health Service Utilization

    2 years

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care (UC) will consist of treatment as usual, standard and systematic alcohol screening as part of the "rooming" process conducted by medical assistants, and brief interventions and referrals to addiction treatment delivered by PCPs. PCPs can also prescribe the same AUD medications as those in the ATC arm.

ATC Service (intervention)

ACTIVE COMPARATOR

ATC components include in-exam-room, real-time videoconferencing or phone contact with the PCPs and their patients, asynchronous, rapid response consultation via email or phone. ATC consultants will offer a flexible service that includes: 1. Direct patient contact, via video or telephone, during primary care visits 2. Motivational Interviewing (MI) - informed facilitation of patient engagement in addiction treatment, 3. Advice to PCP regarding patient-specific treatment options, including pharmacotherapy, addiction treatment, and combined treatments

Other: ATC Intervention

Interventions

ATC InterventionOTHER

The ATC intervention offers convenient access to specialty consultation for PCPs and offers patients direct access to addiction treatment in a non-stigmatized primary care setting

ATC Service (intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult KPNC members who had a primary care visit in Oakland or San Francisco Medical Center between 01/01/2020 and 12/31/2021 (\~250,000)
  • PCPs working in Oakland and San Francisco Medical Centers (\~300).
  • Chief physicians, PCPs, and medical assistants working the intervention arm clinics (n\~40 Key Informants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente

Oakland, California, 94611, United States

Location

Kaiser Permanente

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Metz VE, Leibowitz A, Satre DD, Parthasarathy S, Jackson-Morris M, Cocohoba J, Sterling SA. Effectiveness of a pharmacist-delivered primary care telemedicine intervention to increase access to pharmacotherapy and specialty treatment for alcohol use problems: Protocol for the alcohol telemedicine consult cluster-randomized pragmatic trial. Contemp Clin Trials. 2022 Dec;123:107004. doi: 10.1016/j.cct.2022.107004. Epub 2022 Nov 13.

    PMID: 36379437DERIVED

MeSH Terms

Conditions

AlcoholismAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Stacy A Sterling, DrPh

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 23, 2022

Study Start

September 14, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)