COVID-19 Booster Dose Reminder/Recall for Adolescents

COVID-19 Vaccines Clinical Trial

— AIMED COVID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05571657
• Other study ID #: MCL10517a
• Secondary ID: U01IP001093
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Marshfield Clinic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4304
• Est. completion date: December 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccines

Intervention

Behavioral:
• Reminder/Recall Sent Via Preferred Method of Communication
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)

Locations

Country	Name	City	State
United States	Marshfield Clinic Health System	Marshfield	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marshfield Clinic Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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