- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904744
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
December 13, 2021 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1235
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: No message
No message sent
|
No reminders are sent
|
Active Comparator: Low tailored message
2 text or phone 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
|
Active Comparator: Low tailored message plus COVID-19 vaccine message
2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available
|
2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appointment completed
Time Frame: Within 8 weeks of receiving intervention
|
Appointment completed (yes or no) based on electronic health record documentation
|
Within 8 weeks of receiving intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appointment scheduled
Time Frame: Within 2 weeks of receiving intervention
|
Appointment scheduled (yes or no) based on electronic health record documentation
|
Within 2 weeks of receiving intervention
|
Child receipt of COVID-19 vaccine
Time Frame: Within 8 weeks of receiving intervention
|
COVID-19 vaccine administered (yes or no) based on electronic health record documentation
|
Within 8 weeks of receiving intervention
|
Family member receipt of COVID-19 vaccine
Time Frame: Within 8 weeks of receiving intervention
|
COVID-19 vaccine administered (yes or no) based on electronic health record
|
Within 8 weeks of receiving intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Brinkman, MD, Cincinnati Children's
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
December 10, 2021
Study Registration Dates
First Submitted
May 25, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Actual)
December 14, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0769-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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