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OpenTrials
Completed

NCT Number: NCT04981392

Trusted Messengers: Intervention to Promote 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.

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Vaccination Hesitancy Vaccination Refusal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary care text message outreach to unvaccinated patients and resources to support PCPs

Behavioral

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").

Primary outcomes

  1. COVID-19 Vaccination Within 3 Months

    Time frame: 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).

Secondary outcomes

  1. COVID-19 Vaccination Within 6 Months

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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