Trusted Messengers: Intervention to Promote COVID-19 Vaccination

Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination

The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.

Study Overview

• Status: Completed
• Conditions: Covid19; Vaccination
• Intervention / Treatment: Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPs

Detailed Description

The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.

The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic 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 during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.

• Study Type: Interventional
• Enrollment (Actual): 21844
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients seen by a PCP at a participating clinic site within 3-years prior to study start
• 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
• Non-Massachusetts residents

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Primary care text message outreach to unvaccinated patients and resources to support PCPs	Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPs; Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic 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: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").
No Intervention: Control Arm; Patients will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccination Within 3 Months	The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccination Within 6 Months	The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Kimberly A Fisher, M.D, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): October 25, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Covid-19; Vaccine Hesitancy; Vaccine Confidence
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: H00023254; 1R01MD016883-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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