Clinical trial NCT05252221: Alcohol Telemedicine Consultation in Primary Care (ATC)
Official title: Addiction Telemedicine Consultation in Primary Care: Increasing Access to Pharmacotherapy and Specialty Treatment for Alcohol Problems Via Telehealth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Pharmacist-Patient Relations
Alcohol Problem
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-23
Enrollment: 41843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

Primary outcomes:
measure: Implementation Outcomes
timeFrame: 2 years
measure: Implementation Outcomes
timeFrame: 2 years
measure: AUD Medication Fills
timeFrame: 2 years
measure: Addiction Treatment Initiation Rate
timeFrame: 2 years
measure: Alcohol use (quantity/frequency)
timeFrame: 2 years
measure: Rates of referral to specialty Addiction Medicine department
timeFrame: 2 years
measure: Rates of emergency department utilization in the intervention arms
timeFrame: 2 years
measure: Rates of inpatient services utilization in the intervention arms
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: Stacy A Sterling, DrPh
role: PRINCIPAL_INVESTIGATOR
References:
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.