NCT05096026

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 25, 2021

Last Update Submit

October 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Days to COVID-19 vaccination

    Days to COVID-19 vaccination

    During the 8 weeks after Study Outreach 1 was sent

Study Arms (3)

Standard PCP Outreach

EXPERIMENTAL

These patients were sent standard outreach messages to promote COVID-19 vaccination.

Behavioral: Standard PCP Outreach

Culturally Tailored PCP Outreach

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

These patients were not sent the above study outreach messages, but may have received other messages from their local medical centers or counties.

Interventions

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.

Standard PCP Outreach

These patients were sent messages similar to those in Standard PCP Outreach, but with additional culturally tailored content and photos.

Culturally Tailored PCP Outreach

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Received COVID-19 vaccine prior to Study Outreach 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Related Publications (1)

  • 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 Officials

  • Tracy Lieu, MD

    The Permanente Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Telephone interviewers were blind to study group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

October 27, 2021

Study Start

March 29, 2021

Primary Completion

May 20, 2021

Study Completion

August 31, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
December 1, 2022 through December 1, 2024
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.

Locations