Back to resultsCOVID-19 Booster Dose Reminder/Recall for Adolescents (AIMED COVID)
Primary Purpose
COVID-19 Vaccines
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reminder/Recall Sent Via Preferred Method of Communication
Sponsored by
About this trial
This is an interventional health services research trial for COVID-19 Vaccines focused on measuring reminder/recall, COVID-19, intervention, adolescents
Eligibility Criteria
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
Sites / Locations
- Marshfield Clinic Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual Care
Arm Description
Reminder/recall
No Reminder/Recall
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05571657
First Posted
October 6, 2022
Last Updated
October 10, 2022
Sponsor
Marshfield Clinic Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05571657
Brief Title
COVID-19 Booster Dose Reminder/Recall for Adolescents
Acronym
AIMED COVID
Official Title
Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshfield Clinic Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Vaccines
Keywords
reminder/recall, COVID-19, intervention, adolescents
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Reminder/recall
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No Reminder/Recall
Intervention Type
Behavioral
Intervention Name(s)
Reminder/Recall Sent Via Preferred Method of Communication
Intervention Description
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)
Primary Outcome Measure Information:
Title
COVID-19 Booster Dose
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huong McLean, PhD
Organizational Affiliation
Marshfield Clinic Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marshfield Clinic Health System
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Booster Dose Reminder/Recall for Adolescents
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