Well-Child Visit Trial

September 27, 2022 updated by: Wake Forest University Health Sciences

Text Message Follow-up for Patients Who Have Missed Well-Child Visits: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

739

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reminder
Participants will be sent a text message reminder of their missed well-child visit.
Text messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits.
NO_INTERVENTION: Treatment as usual
This group will receive treatment as usual, which involves no text messaging follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of rescheduled well child visits
Time Frame: 6 weeks after missed well child visit
If parent/guardian rescheduled well child visit
6 weeks after missed well child visit
Number of completed (rescheduled) well child visits
Time Frame: 6 weeks after missed well child visit
If parent/guardian completed (rescheduled) well child visit
6 weeks after missed well child visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of child patient emergency department visits
Time Frame: 6 weeks after missed well child visit
If child patient had an emergency department visit
6 weeks after missed well child visit
Number of child patient hospitalizations
Time Frame: 6 weeks after missed well child visit
If child patient required hospitalization
6 weeks after missed well child visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 13, 2022

Primary Completion (ACTUAL)

August 9, 2022

Study Completion (ACTUAL)

August 9, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (ACTUAL)

October 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00074978-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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