Clinical trial NCT06076863: Pharmacist Management of Paxlovid eVisits
Official title: Pharmacist Management of Paxlovid eVisits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Quality of Care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 2478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Percent of patients with common potential drug-drug interactions with Paxlovid who received counseling
timeFrame: Within 2 days after the e-visit
Secondary outcomes:
measure: Mean hours from e-visit to Paxlovid prescription, among patients who received one
timeFrame: Within 2 days after the e-visit
measure: Mean minutes of clinician time per Paxlovid e-visit managed
timeFrame: Within 2 days after the e-visit
measure: Personnel cost per Paxlovid e-visit managed
timeFrame: Within 5 days after the e-visit
Other outcomes:
measure: Percent of patients rating the quality of care for the Paxlovid e-visit as Excellent or Very Good
timeFrame: At 14 to 28 days after the e-visit
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Tracy Lieu, MD
role: PRINCIPAL_INVESTIGATOR
References: