COVID-19 Booster Dose Reminder/Recall for Adolescents

NCT05571657 | Unknown

• 2 other identifiers: MCL10517aU01IP001093
• Study Type: interventional
• Target: 4,304
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccines

Keywords

reminder/recall; COVID-19; intervention; adolescents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Reminder/recall

Behavioral: Reminder/Recall Sent Via Preferred Method of Communication

Usual Care

NO INTERVENTION

No Reminder/Recall

Interventions

Reminder/Recall Sent Via Preferred Method of Communication BEHAVIORAL

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)

Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead

Study Sites (1)

Marshfield Clinic Health System

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huong McLean, PhD

  Marshfield Clinic Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 7, 2022
• Study Start: May 12, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)