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

Conditions

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

  • United States
    • 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
Other: No message
No reminders are sent
Active Comparator: Low tailored message
2 text or phone reminders that child is overdue for well child check visit
Other: Low tailored message
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
Other: Low tailored message plus COVID-19 vaccine message
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.

Sponsor

Children's Hospital Medical Center, Cincinnati

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.

General Publications

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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