Alcohol Telemedicine Consultation in Primary Care (ATC)

Not Applicable

Completed

• Conditions: Pharmacist-Patient Relations; Alcohol Problem; Alcohol Use Disorder (AUD)
• Interventions: Other: ATC Intervention

• Registration Number: NCT05252221
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-23
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41843

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATC Service (intervention)	ATC 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

Primary Outcome Measures

Name	Time	Method
Rates of emergency department utilization in the intervention arms	2 years	Health Service Utilization
Rates of referral to specialty Addiction Medicine department	2 years	Specialty addiction treatment referrals
Addiction Treatment Initiation Rate	2 years	Addiction Treatment Initiation Rate
Implementation Outcomes	2 years	Rates of referrals to specialty addiction treatment
AUD Medication Fills	2 years	AUD Medication Fills
Rates of inpatient services utilization in the intervention arms	2 years	Health Service Utilization
Alcohol use (quantity/frequency)	2 years	Alcohol use (quantity/frequency)

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 San Francisco, California, United States