AIMED COVID: COVID-19 Booster Dose Reminder/Recall for Adolescents

Sponsor

Marshfield Clinic Research Foundation (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05571657

Collaborator

(none)

4,304

Enrollment

Location

Arms

7.7

Anticipated Duration (Months)

562.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Vaccines	Behavioral: Reminder/Recall Sent Via Preferred Method of Communication	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4304 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 12, 2022

Actual Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Reminder/recall	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)
No Intervention: Usual Care No Reminder/Recall

Arm

Intervention/Treatment

Experimental: Intervention

Reminder/recall

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)

No Intervention: Usual Care

No Reminder/Recall

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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