Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination

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.

Study Overview

• Status: Completed
• Conditions: Health Care Utilization; Preventable Disease, Vaccine
• Intervention / Treatment: Other: 1 automated message; Other: No personal contact attempt; Other: 2 automated messages; Other: 1 personal contact attempt

• Study Type: Interventional
• Enrollment (Actual): 1312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Other: 1 automated message; 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.; Other: No personal contact attempt; No personal contact attempts will be made.
Experimental: Arm 2	Other: No personal contact attempt; No personal contact attempts will be made.; Other: 2 automated messages; 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.
Experimental: Arm 3	Other: 1 automated message; 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.; Other: 1 personal contact attempt; 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.
Experimental: Arm 4	Other: 2 automated messages; 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.; Other: 1 personal contact attempt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of MMR vaccination	MMR administered to child (Yes or No) based on electronic health record documentation	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 Measures

Outcome Measure	Measure Description	Time Frame
Appointment scheduled	Appointment scheduled (Yes or No) based on electronic health record documentation	Within 2 weeks of receiving intervention
Appointment completed	Appointment completed (Yes or No) based on electronic health record documentation	Within 8 weeks of receiving intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Study Director: William B Brinkman, MD, Cincinnati Children's

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): September 5, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vaccine-Preventable Diseases
• Other Study ID Numbers: 2020-0769

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