Well-Child Visit Trial

NCT ID: NCT05086237

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 739 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2022-08-09

Brief Summary

This project will use Twilio as a platform for a text messaging campaign to implement timely follow up with parents/guardians of children ages 0 to 17 years who have missed Well Child Visits (WCVs). The first phase of this project was an open trial. This second phase of the study will be a randomized controlled trial (RCT) to randomly assign parents/guardians of children who missed a WCV to an intervention condition or no intervention, and assess reasons for missed visits and experiences at last visit. Parents/guardians will receive text messages notifying them of missed visits and prompting them to reschedule, as well as inviting them to complete an online survey. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. Outcomes of the follow-up campaign will be evaluated, including rescheduled visits within 6 weeks of missed visit and attendance at rescheduled visit. This aim will incorporate patient Electronic Health Record (EHR) data into mixed effects logistic regressions for the primary study outcomes.

Detailed Description

Well-Child visits (WCV) are an opportunity to maximize the health and future well-being and development of children. Missed visits, however, can result in negative outcomes for patients and families and for the healthcare system. For patients, missed primary care visits can result in greater Emergency Department (ED) visits and hospitalizations, and in delays in diagnosing a variety of medical conditions, including identification of child abuse and neglect. For healthcare systems, missed visits result in decreased efficiency, lower quality measures, decreased provider productivity, and loss in revenue. Although smart phones are nearly ubiquitous, even among more economically disadvantaged populations, literature to date has reported only on using text messages for pre-visit reminders. There is a tremendous opportunity to study use of text messaging to engage families in follow-up for missed WCV. Even more so, testing the use of text messages with different content is missing, as well as using text messages to invite patients to share reasons for missing the last WCV.

Conditions

Child Health; Text Messaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Reminder

Participants will be sent a text message reminder of their missed well-child visit.

Group Type: EXPERIMENTAL

Text message reminders

Intervention Type: OTHER

Text messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits.

Treatment as usual

This group will receive treatment as usual, which involves no text messaging follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text message reminders

Text messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients included in text messaging campaign (caregivers receive text messages):

• Are 0-17 years
• No-showed for a well-child visit scheduled at one of five locations: Pediatrics-Downtown Health Plaza, Family Medicine-Piedmont Plaza, Pediatrics-Winston East, Family Medicine-Peace Haven, or Pediatrics-Clemmons
• Have a phone number on record for a primary caregiver
• With primary language for contact that is English or Spanish

Caregivers must be 18 years or older

Exclusion Criteria

Patients who:

• Are 18+ years old
• No-showed for a different type of visit, or no-showed for a WCV at a different practice location
• Already rescheduled their appointment by the time the sample list was generated
• Have primary language specified that is not English or Spanish.

Caregivers who are under 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Poehling, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

Debinski B, Daniel SS, Rigdon J, Mayfield A, Tzintzun T, Poehling KA. A Pilot Randomized Controlled Trial of Text Messages to Improve Well-Child Visit Attendance After No-Show. Acad Pediatr. 2024 Nov-Dec;24(8):1210-1219. doi: 10.1016/j.acap.2024.06.003. Epub 2024 Jun 7.

Reference Type: DERIVED

PMID: 38852906 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00074978-RCT

Identifier Type: -

Identifier Source: org_study_id