COVID-19 Booster Dose Reminder/Recall for Adolescents

Not Applicable

Active, not recruiting

• Conditions: COVID-19 Vaccines
• Interventions: Behavioral: Reminder/Recall Sent Via Preferred Method of Communication

• Registration Number: NCT05571657
• Lead Sponsor: Marshfield Clinic Research Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Primary Completion: 2022-08-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-07
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Reminder/Recall Sent Via Preferred Method of Communication	Reminder/recall

Primary Outcome Measures

Name	Time	Method
COVID-19 Booster Dose	90 days	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.

Trial Locations

Locations (1)

Marshfield Clinic Health System; 🇺🇸 Marshfield, Wisconsin, United States