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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Quality of Care
• Intervention / Treatment: Other: Pharmacist Care; Other: AFM Pool Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2478
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist Care; Pharmacists on a regional team will manage requests for Paxlovid placed by patients via e-visits using a standard protocol.	Other: Pharmacist Care; Management of Paxlovid e-visits per regional protocol
Active Comparator: Adult and Family Medicine Physician Pool Care; Adult and family medicine physicians serving in pools will manage requests for Paxlovid placed by patients via e-visits using a standard protocol.	Other: AFM Pool Care; Management of Paxlovid e-visits per regional and local protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients with common potential drug-drug interactions with Paxlovid who received counseling	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	Within 2 days after the e-visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean hours from e-visit to Paxlovid prescription, among patients who received one	Hours from e-visit to Paxlovid prescription, among patients who received one, measured via analysis of computerized data	Within 2 days after the e-visit
Mean minutes of clinician time per Paxlovid e-visit managed	Clinician time in minutes per Paxlovid e-visit managed, measured via analysis of computerized data	Within 2 days after the e-visit
Personnel cost per Paxlovid e-visit managed	Personnel cost per Paxlovid e-visit managed	Within 5 days after the e-visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients rating the quality of care for the Paxlovid e-visit as Excellent or Very Good	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.	At 14 to 28 days after the e-visit

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Tracy Lieu, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RDO KPNC 23-096

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