Email-based Reminders Promoting Recommended Pediatric Preventative Visits

Evaluation of Email-based Reminders in Promoting Adherence to the Recommended Pediatric Preventative-visit Schedule Among Rural Patients

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.

Study Overview

• Status: Completed
• Conditions: Immunization Programs
• Intervention / Treatment: Behavioral: Reminder

Detailed Description

Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively.

In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder.

The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days).

• Study Type: Interventional
• Enrollment (Actual): 1186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Did not opt out of emails

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Contact; No reminder sent
Experimental: Reminder; Reminder email with contact information to set an appointment will be sent 12 weeks before the appointment.	Behavioral: Reminder; Email

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
WCC visit made	Binary variable of going to a WCC visit as established by billing codes	30-60 days from the email send date
Immunization status	Binary variable indicating whether pediatric vaccinations are up to date, defined as having no current immunization care gaps	60 days from the email send date

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emails opened	Binary variable of opening the email	60 days from the email send date
Follow-up WCC visit scheduled	Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)	61-150 days from the email send date
Measles, Mumps, and Rubella immunization status	Binary variable indicating whether Measles, Mumps, and Rubella (MMR) vaccinations are up to date, defined as having no current immunization care gaps	60 days from the email send date
Hepatitis A immunization status	Binary variable indicating whether Hepatitis A vaccinations are up to date, defined as having no current immunization care gaps	60 days from the email send date
Hepatitis B immunization status	Binary variable indicating whether Hepatitis B vaccinations are up to date, defined as having no current immunization care gaps	60 days from the email send date
Varicella immunization status	Binary variable indicating whether Varicella vaccinations are up to date, defined as having no current immunization care gaps	60 days from the email send date

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Amir Goren, PhD, Program Director, Behavioral Insights Team

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pediatrics; Child Health; Preventive Medicine; Appointments and Schedules; Reminder Systems
• Other Study ID Numbers: 2021-0106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: The data on the Open Science Framework will be open to anyone requesting that information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No