Pharmacist Management of Paxlovid eVisits

COVID-19 Clinical Trial

Official title:

Pharmacist Management of Paxlovid eVisits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076863
• Other study ID #: RDO KPNC 23-096
• Status: Completed
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2478
• Est. completion date: January 11, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• Quality of Care

Intervention

Other:
• Pharmacist Care
Management of Paxlovid e-visits per regional protocol
• AFM Pool Care
Management of Paxlovid e-visits per regional and local protocols

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Personnel cost per Paxlovid e-visit managed	Personnel cost per Paxlovid e-visit managed	Within 5 days after the e-visit