Pharmacist Management of Paxlovid eVisits

NCT ID: NCT06076863

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2024-01-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Quality of Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Research assistants who review charts will be masked to patient group status.

Study Groups

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Pharmacist Care

Pharmacists on a regional team will manage requests for Paxlovid placed by patients via e-visits using a standard protocol.

Group Type EXPERIMENTAL

Pharmacist Care

Intervention Type OTHER

Management of Paxlovid e-visits per regional protocol

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.

Group Type ACTIVE_COMPARATOR

AFM Pool Care

Intervention Type OTHER

Management of Paxlovid e-visits per regional and local protocols

Interventions

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Pharmacist Care

Management of Paxlovid e-visits per regional protocol

Intervention Type OTHER

AFM Pool Care

Management of Paxlovid e-visits per regional and local protocols

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Lieu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RDO KPNC 23-096

Identifier Type: -

Identifier Source: org_study_id

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