Back to resultsEffect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Primary Purpose
Health Care Utilization, Vaccine Preventable Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low tailored message
No message
Low tailored message plus COVID-19 vaccine message
Sponsored by
About this trial
This is an interventional health services research trial for Health Care Utilization
Eligibility Criteria
Inclusion Criteria:
- age 12-17 years
- has not had a well child check in past 365 days
- no appointment scheduled in next 45 days
- parent preferred language = English or Spanish
Exclusion Criteria:
- phone number not available in electronic health record
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
No message
Low tailored message
Low tailored message plus COVID-19 vaccine message
Arm Description
No message sent
2 text or phone reminders that child is overdue for well child check visit
2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available
Outcomes
Primary Outcome Measures
Appointment completed
Appointment completed (yes or no) based on electronic health record documentation
Secondary Outcome Measures
Appointment scheduled
Appointment scheduled (yes or no) based on electronic health record documentation
Child receipt of COVID-19 vaccine
COVID-19 vaccine administered (yes or no) based on electronic health record documentation
Family member receipt of COVID-19 vaccine
COVID-19 vaccine administered (yes or no) based on electronic health record
Full Information
NCT ID
NCT04904744
First Posted
May 25, 2021
Last Updated
December 13, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04904744
Brief Title
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Official Title
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Care Utilization, Vaccine Preventable Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No message
Arm Type
Placebo Comparator
Arm Description
No message sent
Arm Title
Low tailored message
Arm Type
Active Comparator
Arm Description
2 text or phone reminders that child is overdue for well child check visit
Arm Title
Low tailored message plus COVID-19 vaccine message
Arm Type
Active Comparator
Arm Description
2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available
Intervention Type
Other
Intervention Name(s)
Low tailored message
Intervention Description
2 low tailored text or phone message reminders that child is overdue for well child check visit
Intervention Type
Other
Intervention Name(s)
No message
Intervention Description
No reminders are sent
Intervention Type
Other
Intervention Name(s)
Low tailored message plus COVID-19 vaccine message
Intervention Description
2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
Primary Outcome Measure Information:
Title
Appointment completed
Description
Appointment completed (yes or no) based on electronic health record documentation
Time Frame
Within 8 weeks of receiving intervention
Secondary Outcome Measure Information:
Title
Appointment scheduled
Description
Appointment scheduled (yes or no) based on electronic health record documentation
Time Frame
Within 2 weeks of receiving intervention
Title
Child receipt of COVID-19 vaccine
Description
COVID-19 vaccine administered (yes or no) based on electronic health record documentation
Time Frame
Within 8 weeks of receiving intervention
Title
Family member receipt of COVID-19 vaccine
Description
COVID-19 vaccine administered (yes or no) based on electronic health record
Time Frame
Within 8 weeks of receiving intervention
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:
age 12-17 years
has not had a well child check in past 365 days
no appointment scheduled in next 45 days
parent preferred language = English or Spanish
Exclusion Criteria:
phone number not available in electronic health record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Brinkman, MD
Organizational Affiliation
Cincinnati Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36202236
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
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