Email-based Reminders Promoting Recommended Pediatric Preventative Visits

NCT ID: NCT05317884

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2022-09-13

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.

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).

Conditions

Immunization Programs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

No Contact

No reminder sent

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reminder

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

Group Type: EXPERIMENTAL

Reminder

Intervention Type: BEHAVIORAL

Email

Interventions

Reminder

Email

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Goren

Program Director, Behavioral Insights Team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Goren, PhD

Role: PRINCIPAL_INVESTIGATOR

Program Director, Behavioral Insights Team

Locations

Geisinger

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-0106

Identifier Type: -

Identifier Source: org_study_id