- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076863
Pharmacist Management of Paxlovid eVisits
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tracy Lieu, MD
- Phone Number: 510-891-3407
- Email: tracy.lieu@kp.org
Study Locations
-
-
California
-
Oakland, California, United States, 94612
- Kaiser Permanente Northern California
-
Contact:
- Tracy Lieu
- Phone Number: 510-891-3407
- Email: tracy.lieu@kp.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients making Paxlovid e-visits on weekdays from 8:00 am to 4:30 pm during the study period
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Management of Paxlovid e-visits per regional and local protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients with common potential drug-drug interactions with Paxlovid who received counseling
Time Frame: 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
|
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
Time Frame: 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
|
Within 2 days after the e-visit
|
Mean minutes of clinician time per Paxlovid e-visit managed
Time Frame: Within 2 days after the e-visit
|
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
Time Frame: Within 5 days after the e-visit
|
Personnel cost per Paxlovid e-visit managed
|
Within 5 days after the e-visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients rating the quality of care for the Paxlovid e-visit as Excellent or Very Good
Time Frame: 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.
|
At 14 to 28 days after the e-visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tracy Lieu, MD, Kaiser Permanente
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RDO KPNC 23-096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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