Alcohol Telemedicine Consultation in Primary Care (ATC)

NCT ID: NCT05252221

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41843 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

ATC Service (intervention)

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

Group Type ACTIVE_COMPARATOR

ATC Intervention

Intervention Type OTHER

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

Interventions

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ATC Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacy A Sterling, DrPh

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente

Oakland, California, United States

Site Status

Kaiser Permanente

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36379437 (View on PubMed)

Other Identifiers

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R01AA028211

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1564446

Identifier Type: -

Identifier Source: org_study_id

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