Pharmacist Management of Paxlovid eVisits

Sponsor
Kaiser Permanente (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06076863
Collaborator
(none)
1,560
1
2
3.1
505.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacist Care
  • Other: AFM Pool Care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1560 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Research assistants who review charts will be masked to patient group status.
Primary Purpose:
Health Services Research
Official Title:
Pharmacist Management of Paxlovid eVisits
Anticipated Study Start Date :
Oct 9, 2023
Anticipated Primary Completion Date :
Dec 11, 2023
Anticipated Study Completion Date :
Jan 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacist Care

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

Other: Pharmacist Care
Management of Paxlovid e-visits per regional protocol

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Percent of patients with common potential drug-drug interactions with Paxlovid who received counseling [Within 2 days after the e-visit]

    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

Secondary Outcome Measures

  1. Mean hours from e-visit to Paxlovid prescription, among patients who received one [Within 2 days after the e-visit]

    Hours from e-visit to Paxlovid prescription, among patients who received one, measured via analysis of computerized data

  2. Mean minutes of clinician time per Paxlovid e-visit managed [Within 2 days after the e-visit]

    Clinician time in minutes per Paxlovid e-visit managed, measured via analysis of computerized data

  3. Personnel cost per Paxlovid e-visit managed [Within 5 days after the e-visit]

    Personnel cost per Paxlovid e-visit managed

Other Outcome Measures

  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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients making Paxlovid e-visits on weekdays from 8:00 am to 4:30 pm during the study period
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Northern California Oakland California United States 94612

Sponsors and Collaborators

  • Kaiser Permanente

Investigators

  • Principal Investigator: Tracy Lieu, MD, Kaiser Permanente

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT06076863
Other Study ID Numbers:
  • RDO KPNC 23-096
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 11, 2023