Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients

This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Standard PCP Outreach; Behavioral: Culturally Tailored PCP Outreach

Detailed Description

This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Patients who had not received a COVID-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their PCP, (b) similar outreach with additional culturally tailored content, or (c) usual care. The primary outcome was receipt of COVID-19 vaccination during the 8 weeks after the initial study outreach date.

• Study Type: Interventional
• Enrollment (Actual): 8287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

Received COVID-19 vaccine prior to Study Outreach 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard PCP Outreach; These patients were sent standard outreach messages to promote COVID-19 vaccination.	Behavioral: Standard PCP Outreach; These patients were sent two study outreach messages. Study Outreach 1 was an electronic secure message sent on behalf of the PCP, encouraging COVID-19 vaccination and designed based on behavioral science principles. Letters were sent to patients who had not signed up for the electronic health record portal. Study Outreach 2 was a postcard sent to all patients who had not been vaccinated or made an appointment by four weeks after Study Outreach 1.
Experimental: Culturally Tailored PCP Outreach; These patients were sent messages similar to those in the Standard PCP Outreach Group, but with additional culturally tailored content.	Behavioral: Culturally Tailored PCP Outreach; These patients were sent messages similar to those in Standard PCP Outreach, but with additional culturally tailored content and photos.
No Intervention: Usual Care; These patients were not sent the above study outreach messages, but may have received other messages from their local medical centers or counties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to COVID-19 vaccination	Days to COVID-19 vaccination	During the 8 weeks after Study Outreach 1 was sent

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Tracy Lieu, MD, The Permanente Medical Group

Publications and helpful links

General Publications

• Lieu TA, Elkin EP, Escobar PR, Finn L, Klein NP, Durojaiye C, Prausnitz S, Quesenberry CP, Sawyer D, Teran S, Goler N, Parodi SM, Chen YI. Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217004. doi: 10.1001/jamanetworkopen.2022.17004.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RDO KPNC 21-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified data will be shared on submission of a protocol approved by the Kaiser Permanente Northern California Institutional Review Board or Research Determination Official, and contingent on appropriate data sharing agreement being completed.
• IPD Sharing Time Frame: December 1, 2022 through December 1, 2024
• IPD Sharing Access Criteria: Deidentified data will be shared on submission of a protocol approved by the Kaiser Permanente Northern California Institutional Review Board or Research Determination Official, and contingent on appropriate data sharing agreement being completed.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No