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Intervention to Promote COVID-19 Vaccination

Primary Purpose

Covid19, Vaccination

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health System Vaccination Text Messages and Provider Education
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Covid-19, Vaccine Hesitancy, Vaccine Confidence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMass Chan Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multi-component patient and provider intervention to promote COVID-19 vaccination

Usual care

Arm Description

Patients will receive usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 26, 2021
Last Updated
February 6, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04981392
Brief Title
Intervention to Promote COVID-19 Vaccination
Official Title
Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccination
Keywords
Covid-19, Vaccine Hesitancy, Vaccine Confidence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
26118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-component patient and provider intervention to promote COVID-19 vaccination
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Health System Vaccination Text Messages and Provider Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Title
Rate-ratio for vaccination rates between minority racial groups (Black, Latino, Asian) and the White population.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Fisher, M.D
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intervention to Promote COVID-19 Vaccination

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