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Alcohol Telemedicine Consultation in Primary Care (ATC) (ATC)

Primary Purpose

Alcohol Use Disorder (AUD), Pharmacist-Patient Relations, Alcohol Problem

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ATC Intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

Sites / Locations

  • Kaiser PermanenteRecruiting
  • Kaiser PermanenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

ATC Service (intervention)

Arm Description

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 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: Direct patient contact, via video or telephone, during primary care visits Motivational Interviewing (MI) - informed facilitation of patient engagement in addiction treatment, Advice to PCP regarding patient-specific treatment options, including pharmacotherapy, addiction treatment, and combined treatments

Outcomes

Primary Outcome Measures

Implementation Outcomes
AUD Medication Prescription Rate
Implementation Outcomes
Rates of referrals to specialty addiction treatment
AUD Medication Fills
AUD Medication Fills
Addiction Treatment Initiation Rate
Addiction Treatment Initiation Rate
Alcohol use (quantity/frequency)
Alcohol use (quantity/frequency)
Rates of referral to specialty Addiction Medicine department
Specialty addiction treatment referrals
Rates of emergency department utilization in the intervention arms
Health Service Utilization
Rates of inpatient services utilization in the intervention arms
Health Service Utilization

Secondary Outcome Measures

Full Information

First Posted
January 28, 2022
Last Updated
March 7, 2023
Sponsor
Kaiser Permanente
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05252221
Brief Title
Alcohol Telemedicine Consultation in Primary Care (ATC)
Acronym
ATC
Official Title
Addiction Telemedicine Consultation in Primary Care: Increasing Access to Pharmacotherapy and Specialty Treatment for Alcohol Problems Via Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will examine the effectiveness of a multi-faceted intervention - the Addiction Telemedicine Consultant service, or "ATC," which consists of: A 1-hour information session for Primary Care Providers (PCP) about alcohol problems; including alcohol use disorder (AUD) and AUD pharmacotherapy, provided by the research team in collaboration with Kaiser Permanente Northern California (KPNC) addiction medicine and clinical pharmacy leadership. Along with a post session evaluation via survey monkey. PCP access to expert addiction medicine consultation by KPNC clinical pharmacists, via telephone, videoconference, and secure messaging - during primary care patient visits with the patient present, or asynchronously without the patient present. Real-time, in-exam-room consultations may include clinical pharmacist assistance with patient assessment, psychoeducation, motivational interventions, and facilitation of patient engagement in addiction treatment. Asynchronous consultations without the patient present may include clinical pharmacist advice regarding patient-specific treatment options, including pharmacotherapy, psychosocial treatment, and combined treatments, Ongoing technical assistance for PCPs, including coaching and troubleshooting on alcohol problems assessment and AUD medication prescribing and treatment entry facilitation, from the ATC consultants, as needed. This study will use electronic health record (EHR) data to examine treatment arm effects on implementation outcomes and patient outcomes recorded during the course of regular clinical care, and health services utilization over two years. The study will accomplish this through the following specific aims: Aim 1: To compare the ATC and Usual Care arms on implementation outcomes: AUD medication prescription order rates and specialty addiction treatment referrals over two years. Aim 2: To compare the ATC and UC arms on patient outcomes: AUD medication fills, addiction treatment initiation, alcohol use (quantity/frequency), and services utilization over two years. Aim 3: To understand characteristics associated with ATC implementation, and barriers and facilitators of AUD medication prescription. We will examine provider characteristics (including potential race/ethnic and gender disparities) associated with ATC implementation outcomes using EHR and semi-structured qualitative interviews with PCPs and explore how the different elements of ATC (video consult, telephone, and email) facilitate its implementation. Provider characteristics and EHR portions of this aim involve data only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD), Pharmacist-Patient Relations, Alcohol Problem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
ATC Service (intervention)
Arm Type
Active Comparator
Arm Description
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: Direct patient contact, via video or telephone, during primary care visits Motivational Interviewing (MI) - informed facilitation of patient engagement in addiction treatment, Advice to PCP regarding patient-specific treatment options, including pharmacotherapy, addiction treatment, and combined treatments
Intervention Type
Other
Intervention Name(s)
ATC Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Implementation Outcomes
Description
AUD Medication Prescription Rate
Time Frame
2 years
Title
Implementation Outcomes
Description
Rates of referrals to specialty addiction treatment
Time Frame
2 years
Title
AUD Medication Fills
Description
AUD Medication Fills
Time Frame
2 years
Title
Addiction Treatment Initiation Rate
Description
Addiction Treatment Initiation Rate
Time Frame
2 years
Title
Alcohol use (quantity/frequency)
Description
Alcohol use (quantity/frequency)
Time Frame
2 years
Title
Rates of referral to specialty Addiction Medicine department
Description
Specialty addiction treatment referrals
Time Frame
2 years
Title
Rates of emergency department utilization in the intervention arms
Description
Health Service Utilization
Time Frame
2 years
Title
Rates of inpatient services utilization in the intervention arms
Description
Health Service Utilization
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy S Leibowitz, Psy.D
Phone
510-909-9358
Email
Amy.S.Leibowitz@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie J Morris
Phone
916-204-0137
Email
Melanie.J.Jackson-Morris@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy A Sterling, DrPh
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy A Leibowitz, Psy.D
Phone
510-909-9358
Email
Amy.S.Leibowitz@kp.org
First Name & Middle Initial & Last Name & Degree
Stacy A Sterling, DrPh
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy A Leibowitz, Psy.D
Phone
510-909-9358
Email
Amy.S.Leibowitz@kp.org
First Name & Middle Initial & Last Name & Degree
Stacy A Sterling, DrPh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36379437
Citation
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.
Results Reference
derived

Learn more about this trial

Alcohol Telemedicine Consultation in Primary Care (ATC)

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