COVID-19 Booster Dose Reminder/Recall for Adolescents

Study Overview
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Brief Summary
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A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.

Official Title
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Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas

Conditions
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COVID-19 Vaccines

Intervention / Treatment
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* Behavioral: Reminder/Recall Sent Via Preferred Method of Communication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation & management visits with a Marshfield Clinic Health System provider in the last 36 months Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose) Exclusion Criteria: Primary care provider is not affiliated with Marshfield Clinic Health System Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications Received COVID-19 vaccine off label Missing or invalid contact information Deceased

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Reminder/recall | Behavioral: Reminder/Recall Sent Via Preferred Method of Communication<br>* Parents of 12-17 year-old patients due for COVID-19 booster dose will receive a one-time vaccine reminder/recall via the parent's preferred method of communication (mailed letter, text message, email)<br>|
| No Intervention: Usual Care<br>No Reminder/Recall | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Booster Dose | Number of patients that received a COVID-19 booster dose during follow-up based on electronic health data. Receipt of a COVID-19 booster dose within 90 days of randomization (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System (MCHS) electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received a COVID-19 booster dose if they have record of receipt of COVID-19 booster dose with a vaccination date during the 90-day follow-up period. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reminder/recall, COVID-19, intervention, adolescents