Back to resultsEffect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Primary Purpose
Preventable Disease, Vaccine, Health Care Utilization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1 automated message
2 automated messages
No personal contact attempt
1 personal contact attempt
Sponsored by
About this trial
This is an interventional health services research trial for Preventable Disease, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Age: 12-14 months old OR 4 years old
- Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
- Has not had a well child check in past 365 days (for 4 year olds)
- No appointment scheduled in the next 45 days
- Parent preferred language = English or Spanish
Exclusion Criteria:
- Phone number not available in electronic medical record
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Receipt of MMR vaccination
MMR administered to child (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
Appointment completed
Appointment completed (Yes or No) based on electronic health record documentation
Full Information
NCT ID
NCT04567342
First Posted
September 23, 2020
Last Updated
October 12, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04567342
Brief Title
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Official Title
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
September 5, 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 (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the MMR vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventable Disease, Vaccine, Health Care Utilization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
1 automated message
Intervention Description
Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
Intervention Type
Other
Intervention Name(s)
2 automated messages
Intervention Description
Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
Intervention Type
Other
Intervention Name(s)
No personal contact attempt
Intervention Description
No personal contact attempts will be made.
Intervention Type
Other
Intervention Name(s)
1 personal contact attempt
Intervention Description
Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment.
Primary Outcome Measure Information:
Title
Receipt of MMR vaccination
Description
MMR administered to child (Yes or No) based on electronic health record documentation
Time Frame
By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old)
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
Appointment completed
Description
Appointment completed (Yes or No) based on electronic health record documentation
Time Frame
Within 8 weeks of receiving intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 12-14 months old OR 4 years old
Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
Has not had a well child check in past 365 days (for 4 year olds)
No appointment scheduled in the next 45 days
Parent preferred language = English or Spanish
Exclusion Criteria:
Phone number not available in electronic medical record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B Brinkman, MD
Organizational Affiliation
Cincinnati Children's
Official's Role
Study Director
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
Learn more about this trial
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
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