NCT05086237

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
739

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

September 30, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

September 15, 2021

Last Update Submit

September 27, 2022

Conditions

Keywords

child healthwell child visitstext messaging

Outcome Measures

Primary Outcomes (2)

  • Number of rescheduled well child visits

    If parent/guardian rescheduled well child visit

    6 weeks after missed well child visit

  • Number of completed (rescheduled) well child visits

    If parent/guardian completed (rescheduled) well child visit

    6 weeks after missed well child visit

Secondary Outcomes (2)

  • Number of child patient emergency department visits

    6 weeks after missed well child visit

  • Number of child patient hospitalizations

    6 weeks after missed well child visit

Study Arms (2)

Reminder

EXPERIMENTAL

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

Other: Text message reminders

Treatment as usual

NO INTERVENTION

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

Interventions

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

Reminder

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Katherine Poehling, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The second phase of the study will be an randomized controlled trial 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. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 20, 2021

Study Start

May 13, 2022

Primary Completion

August 9, 2022

Study Completion

August 9, 2022

Last Updated

September 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations