Intervention to Promote COVID-19 Vaccination

Covid19 Clinical Trial

Official title:

Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981392
• Other study ID #: H00023254
• Secondary ID: 1R01MD016883-01
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: October 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to implement and assess the impact of a multi-faceted intervention to support Primary Care Provider (PCP) outreach, and PCP and community organization dissemination of information to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA.

Description:

The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic provider recommendations via text message outreach, information provision, and provider support. The clinical trial will randomize primary care clinics from three health systems in the Worcester, Massachusetts area to the intervention. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients, including access to the study website, a "tip sheet" for talking with vaccine hesitant patients, and additional materials to share with vaccine hesitant patients during the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26118
• Est. completion date: May 16, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients and providers at a participating clinic site
• Age > 18 years

Exclusion Criteria:

• Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccination

Intervention

Behavioral:
• Health System Vaccination Text Messages and Provider Education
Patients: Eligible patients will receive a series of text messages from their PCP recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: will receive educational materials to support their conversations with patients about the COVID-19 vaccines.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of unvaccinated patients who receive at least one dose of a COVID-19 vaccine series 12 weeks after the last text message is sent out to eligible patients	Completion of COVID-19 vaccine series will be ascertained via the Electronic Health Record (EHR). The proportion will be calculated by dividing the number of unvaccinated patients who receive at least one dose of a COVID-19 vaccine series by the total number of eligible patients across intervention clinics.	12 weeks
Secondary	Proportion of unvaccinated patients who receive at least one dose of a COVID-19 vaccine series 6 months after the last text message is sent out to eligible patients.	Completion of COVID-19 vaccine series will be ascertained via the Electronic Health Record (EHR) 6 months after the last text message is sent out to eligible patients. The proportion will be calculated by dividing the number of unvaccinated patients who receive at least one dose of a COVID-19 vaccine series by the total number of eligible patients across intervention clinics.	6 months
Secondary	Rate-ratio for vaccination rates between minority racial groups (Black, Latino, Asian) and the White population.	The rate-ratio will be calculated post-intervention by dividing the vaccination rate among patients in each minority racial group by the vaccination rate among patients in the White population.	1 year