Alcohol Telemedicine Consultation in Primary Care (ATC)

Alcohol Use Disorder (AUD) Clinical Trial

— ATC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252221
• Other study ID #: 1564446
• Secondary ID: R01AA028211
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41843
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Alcohol Problem
• Alcohol Use Disorder (AUD)
• Alcohol-Related Disorders
• Alcoholism
• Pharmacist-Patient Relations

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente	Oakland	California
United States	Kaiser Permanente	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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