NCT05317884

Brief Summary

The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2022

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

March 22, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

PediatricsReminder SystemsPreventive MedicineChild HealthAppointments and Schedules

Outcome Measures

Primary Outcomes (1)

  • WCC visit scheduled

    Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)

    30-60 days from the email send date

Secondary Outcomes (2)

  • WCC visit made

    30-60 days from the email send date

  • Immunization status

    60 days from the email send date

Other Outcomes (6)

  • Emails opened

    60 days from the email send date

  • Follow-up WCC visit scheduled

    61-150 days from the email send date

  • Measles, Mumps, and Rubella immunization status

    60 days from the email send date

  • +3 more other outcomes

Study Arms (2)

No Contact

NO INTERVENTION

No reminder sent

Reminder

EXPERIMENTAL

Reminder email with contact information to set an appointment will be sent 12 weeks before the appointment.

Behavioral: Reminder

Interventions

ReminderBEHAVIORAL

Email

Reminder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months
  • No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18)
  • Has an email address on record
  • Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit)

You may not qualify if:

  • Did not opt out of emails

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Study Officials

  • Amir Goren, PhD

    Program Director, Behavioral Insights Team

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The participants and providers will not know that email reminders were randomized. Participants who received an email (and their providers if they shared this email) will know that they have received an email, but it is not likely that they will know that other participants did not receive an email (and vice-versa).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: No reminder group vs. reminder group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Behavioral Insights Team

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 8, 2022

Study Start

May 16, 2022

Primary Completion

September 13, 2022

Study Completion

September 13, 2022

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
More information

Locations