Pharmacist Management of Paxlovid eVisits

NCT06076863 | Completed

• 1 other identifier: RDO KPNC 23-096
• Study Type: interventional
• Target: 2,478
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Quality of Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean hours from e-visit to Paxlovid prescription, among patients who received one

  Within 2 days after the e-visit

• Mean minutes of clinician time per Paxlovid e-visit managed

  Within 2 days after the e-visit

• Personnel cost per Paxlovid e-visit managed

  Within 5 days after the e-visit

Other Outcomes (1)

• Percent of patients rating the quality of care for the Paxlovid e-visit as Excellent or Very Good

  At 14 to 28 days after the e-visit

Study Arms (2)

Pharmacist Care

EXPERIMENTAL

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

Other: Pharmacist Care

Adult and Family Medicine Physician Pool Care

ACTIVE COMPARATOR

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

Interventions

Pharmacist Care OTHER

Management of Paxlovid e-visits per regional protocol

Pharmacist Care

AFM Pool Care OTHER

Management of Paxlovid e-visits per regional and local protocols

Adult and Family Medicine Physician Pool Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tracy Lieu, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants who review charts will be masked to patient group status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: October 9, 2023
• Primary Completion: December 11, 2023
• Study Completion: January 11, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)