Email-based Reminders Promoting Recommended Pediatric Preventative Visits

Immunization Programs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317884
• Other study ID #: 2021-0106
• Status: Completed
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: September 13, 2022

Study information

• Verified date: November 2022
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1186
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunization Programs

Intervention

Behavioral:
• Reminder
Email

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emails opened	Binary variable of opening the email	60 days from the email send date
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	WCC visit made	Binary variable of going to a WCC visit as established by billing codes	30-60 days from the email send date
Secondary	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