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Completed

NCT Number: NCT06076863

Pharmacist Management of Paxlovid eVisits

The goal of this cluster randomized trial is to compare two modes of management -- pharmacist care vs. pooled adult and family medicine physician care -- for electronically submitted requests (e-visits) for Paxlovid by adults with COVID-19. It will compare quality of care based on counseling for common potential drug-drug interactions and time to prescription, as well as the time and financial costs of care in the two groups.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Quality Of Care RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

About this study

Importance. Enhancing the management of messages from patients and providing virtual options for urgent care are top priorities for The Permanente Medical Group (TPMG) and Kaiser Foundation Hospitals/Health Plan (KFH/P).

Objective. To compare pharmacist management of e-visit requests for Paxlovid for COVID-19 with management by adult and family medicine physician pools regarding costs, time, clinical outcomes, and patient and clinician satisfaction.

Design, setting, and participants. This cluster randomized clinical trial will include adults from 17 medical facilities of Kaiser Permanente Northern California who make Paxlovid e-visits on weekdays from October 9 to December 11, 2023.

Intervention. In the intervention group, a regional team of pharmacists will manage Paxlovid e-visits following a standard protocol; in the comparison group, adult and family medicine physicians (AFMs) will manage these visits according to medical center-based protocols.

Main Outcomes and Measures. The primary outcome is whether a patient with one or more common drug-drug interactions received counseling for any drug-drug interaction. Secondary outcomes are the hours from the e-visit request to the prescription among patients who receive one and the clinician time and cost per visit managed.

Potential Results. We will test the hypotheses that Pharmacist Care compared with AFM Pool Care will have higher quality of care and lower costs based on the receipt of counseling for common drug-drug interactions, faster time to prescriptions, and lower clinician time and cost per visit managed.

Potential Conclusions and Relevance. If pharmacist management has better or similar outcomes compared with AFM pool management, this will provide support to continue this practice for Paxlovid e-visits and to evaluate possible expansion of pharmacist management for similar clinical situations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients making Paxlovid e-visits on weekdays from 8:00 am to 4:30 pm during the study period

Exclusion criteria

  • None

Treatment and study plan

Pharmacist care

Other

Management of Paxlovid e-visits per regional protocol

AFM Pool Care

Other

Management of Paxlovid e-visits per regional and local protocols

Primary outcomes

  1. Percent of patients with common potential drug-drug interactions with Paxlovid who received counseling

    Time frame: Within 2 days after the e-visit

    Whether or not a patient with one or more common potential drug-drug interactions with Paxlovid received counseling, as documented in the electronic health record, with data collected via review of text extracts from the EHR

Secondary outcomes

  1. Mean hours from e-visit to Paxlovid prescription, among patients who received one

    Time frame: Within 2 days after the e-visit

    Hours from e-visit to Paxlovid prescription, among patients who received one, measured via analysis of computerized data

  2. Mean minutes of clinician time per Paxlovid e-visit managed

    Time frame: Within 2 days after the e-visit

    Clinician time in minutes per Paxlovid e-visit managed, measured via analysis of computerized data

  3. Personnel cost per Paxlovid e-visit managed

    Time frame: Within 5 days after the e-visit

    Personnel cost per Paxlovid e-visit managed

Other outcomes

  1. Percent of patients rating the quality of care for the Paxlovid e-visit as Excellent or Very Good

    Time frame: At 14 to 28 days after the e-visit

    Patient rating of the quality of care for the Paxlovid e-visit, measured on a 5-point scale with the response options Excelllent, Very Good, Good, Fair, or Poor, with survey responses collected via mail, online, and telephone interviews.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Mar 4, 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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