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

Addiction Telemedicine Consultation in Primary Care: Increasing Access to Pharmacotherapy and Specialty Treatment for Alcohol Problems Via Telehealth

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.

Study Overview

• Status: Completed
• Conditions: Pharmacist-Patient Relations; Alcohol Use Disorder (AUD); Alcohol Problem
• Intervention / Treatment: Other: ATC Intervention

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 Type: Interventional
• Enrollment (Actual): 41843
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente
    • San Francisco, California, United States, 94115
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Stacy A Sterling, DrPH, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcoholism; Alcohol-Related Disorders
• Other Study ID Numbers: 1564446; R01AA028211 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No