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Completed

NCT Number: NCT05252221

Alcohol Telemedicine Consultation in Primary Care (ATC)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATC Intervention

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

Primary outcomes

  1. Implementation Outcomes

    Time frame: 2 years

    AUD Medication Prescription Rate

  2. Implementation Outcomes

    Time frame: 2 years

    Rates of referrals to specialty addiction treatment

  3. AUD Medication Fills

    Time frame: 2 years

    AUD Medication Fills

  4. Addiction Treatment Initiation Rate

    Time frame: 2 years

    Addiction Treatment Initiation Rate

  5. Alcohol use (quantity/frequency)

    Time frame: 2 years

    Alcohol use (quantity/frequency)

  6. Rates of referral to specialty Addiction Medicine department

    Time frame: 2 years

    Specialty addiction treatment referrals

  7. Rates of emergency department utilization in the intervention arms

    Time frame: 2 years

    Health Service Utilization

  8. Rates of inpatient services utilization in the intervention arms

    Time frame: 2 years

    Health Service Utilization

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: ATC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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