Intervention to Promote COVID-19 Vaccination

• ClinicalTrials.gov Identifier: NCT04981392
• Recruitment Status: Active, not recruiting
• First Posted: July 29, 2021
• Last Update Posted: February 8, 2023
• Sponsor: University of Massachusetts, Worcester
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Kimberly Fisher, University of Massachusetts, Worcester

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Covid19; Vaccination	Behavioral: Health System Vaccination Text Messages and Provider Education	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The intervention will be implemented using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by site, and other characteristics as possible. Within each pair, clinics will be randomly allocated to intervention/usual care Arm.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination
• Actual Study Start Date: June 2, 2022
• Estimated Primary Completion Date: September 1, 2023
• Estimated Study Completion Date: September 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Multi-component patient and provider intervention to promote COVID-19 vaccination	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.
No Intervention: Usual care; Patients will receive usual care

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. 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. [ Time Frame: 6 months ]
   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.
2. Rate-ratio for vaccination rates between minority racial groups (Black, Latino, Asian) and the White population. [ Time Frame: 1 year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

UMass Chan Medical School

Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators

University of Massachusetts, Worcester

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Kimberly A Fisher, M.D; University of Massachusetts, Worcester

More Information

• Responsible Party: Kimberly Fisher, Associate Professor, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT04981392
• Other Study ID Numbers: H00023254; 1R01MD016883-01 ( U.S. NIH Grant/Contract )
• First Posted: July 29, 2021
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kimberly Fisher, University of Massachusetts, Worcester:

Covid-19; Vaccine Hesitancy; Vaccine Confidence

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases