Intervention to Promote COVID-19 Vaccination

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination

Conditions
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Covid19, Vaccination

Intervention / Treatment
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* Behavioral: Health System Vaccination Text Messages and Provider Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component patient and provider intervention to promote COVID-19 vaccination<br> | Behavioral: Health System Vaccination Text Messages and Provider Education<br>* 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.<br>|
| No Intervention: Usual care<br>Patients will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Vaccine Hesitancy, Vaccine Confidence