Pharmacist Management of Paxlovid eVisits

Study Overview
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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.

Official Title
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Pharmacist Management of Paxlovid eVisits

Conditions
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COVID-19, Quality of Care

Intervention / Treatment
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* Other: Pharmacist Care
* Other: AFM Pool Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Care<br>Pharmacists on a regional team will manage requests for Paxlovid placed by patients via e-visits using a standard protocol. | Other: Pharmacist Care<br>* Management of Paxlovid e-visits per regional protocol<br>|
| Active Comparator: Adult and Family Medicine Physician Pool Care<br>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<br>* Management of Paxlovid e-visits per regional and local protocols<br>|

What is the study measuring?
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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 |