Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
1 other identifier
interventional
1,235
1 country
1
Brief Summary
Our objective is to determine the effectiveness of varied outreach methods to children age 12-17 years old who are due for a well child check visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the COVID-19 vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2021
CompletedResults Posted
Study results publicly available
October 28, 2024
CompletedOctober 28, 2024
August 1, 2024
5 months
May 25, 2021
January 10, 2023
August 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Completed an Adolescent Well-care Visit
Participant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record
Within 8 weeks of the date of intervention or the date of randomization for the control group
Secondary Outcomes (3)
Number of Participants Who Scheduled an Adolescent Well-care Appointment
Within 2 weeks of the date of intervention or the date of randomization for the control group
Participant Receipt of COVID-19 Vaccine
Within 8 weeks of the date of intervention or the date of randomization for the control group
Family Member Receipt of COVID-19 Vaccine
Within 8 weeks of the date of intervention or the date of randomization for the control group
Study Arms (3)
No message
PLACEBO COMPARATORNo message sent
Low tailored message
ACTIVE COMPARATOR2 text or phone reminders that child is overdue for well child check visit
Low tailored message plus COVID-19 vaccine message
ACTIVE COMPARATOR2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available
Interventions
2 low tailored text or phone message reminders that child is overdue for well child check visit
2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
Eligibility Criteria
You may qualify if:
- age 12-17 years
- has not had a well child check in past 365 days
- no future well child check visit scheduled
- parent preferred language = English or Spanish
You may not qualify if:
- phone number not available in electronic health record
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Related Publications (1)
Burkhardt MC, Berset AE, Xu Y, Mescher A, Brinkman WB. Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. J Pediatr. 2023 Feb;253:158-164.e1. doi: 10.1016/j.jpeds.2022.09.035. Epub 2022 Oct 4.
PMID: 36202236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. William B. Brinkman
- Organization
- Cincinnati Children's
Study Officials
- PRINCIPAL INVESTIGATOR
William Brinkman, MD
Cincinnati Children's
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 27, 2021
Study Start
May 28, 2021
Primary Completion
October 31, 2021
Study Completion
December 10, 2021
Last Updated
October 28, 2024
Results First Posted
October 28, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share