NCT04567342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

September 23, 2020

Results QC Date

August 17, 2023

Last Update Submit

August 7, 2024

Conditions

Preventable Disease, VaccineHealth Care Utilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Appointment Scheduled

    Within 2 weeks of receiving intervention

  • Appointment Completed

    Within 8 weeks of receiving intervention

Study Arms (4)

Arm 1

EXPERIMENTAL
Other: 1 automated messageOther: No personal contact attempt

Arm 2

EXPERIMENTAL
Other: 2 automated messagesOther: No personal contact attempt

Arm 3

EXPERIMENTAL
Other: 1 automated messageOther: 1 personal contact attempt

Arm 4

EXPERIMENTAL
Other: 2 automated messagesOther: 1 personal contact attempt

Interventions

1 automated messageOTHER

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.

Arm 1Arm 3
2 automated messagesOTHER

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.

Arm 2Arm 4
No personal contact attemptOTHER

No personal contact attempts will be made.

Arm 1Arm 2
1 personal contact attemptOTHER

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.

Arm 3Arm 4

Eligibility Criteria

Age12 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Phone number not available in electronic medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Vaccine-Preventable DiseasesPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

InfectionsTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. William B. Brinkman
Organization
Cincinnati Children's
bill.brinkman@cchmc.org
513-636-2576

Study Officials

  • William B Brinkman, MD

    Cincinnati Children's

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 28, 2020

Study Start

November 27, 2020

Primary Completion

August 6, 2021

Study Completion

September 5, 2021

Last Updated

August 12, 2024

Results First Posted

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)