- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086237
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
Conditions
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
Keywords
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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