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

NCT ID: NCT05096026

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Telephone interviewers were blind to study group assignment.

Study Groups

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Standard PCP Outreach

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

Group Type EXPERIMENTAL

Standard PCP Outreach

Intervention Type BEHAVIORAL

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.

Culturally Tailored PCP Outreach

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

Group Type EXPERIMENTAL

Culturally Tailored PCP Outreach

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

Received COVID-19 vaccine prior to Study Outreach 1.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Lieu, MD

Role: PRINCIPAL_INVESTIGATOR

The Permanente Medical Group

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35713906 (View on PubMed)

Other Identifiers

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RDO KPNC 21-044

Identifier Type: -

Identifier Source: org_study_id