Child HealthNCT05086237
Well-Child Visit Trial
A study testing Text message reminders in people with Child Health and Text Messaging, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Health, Text Messaging
- What is being tested?
- Text message reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Being tested
- Text message reminders
- Keywords
- child health, well child visits, text messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message remindersOther
Text messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits.
| Study group | Role | What they receive |
|---|---|---|
| Reminder | Experimental | Participants will be sent a text message reminder of their missed well-child visit. Receives: Other: Text message reminders |
| Treatment as usual | No intervention | This group will receive treatment as usual, which involves no text messaging follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of rescheduled well child visits
If parent/guardian rescheduled well child visit
Measured: 6 weeks after missed well child visit
Number of completed (rescheduled) well child visits
If parent/guardian completed (rescheduled) well child visit
Measured: 6 weeks after missed well child visit
Secondary outcomes (2)
Number of child patient emergency department visits
If child patient had an emergency department visit
Measured: 6 weeks after missed well child visit
Number of child patient hospitalizations
If child patient required hospitalization
Measured: 6 weeks after missed well child visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start13 May 2022
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Poehling, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086237
- Sponsor's protocol ID
- IRB00074978-RCT
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38852906
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Follow-up for Patients Who Have Missed Well-Child Visits: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05086237
- Acronym / sponsor ID
- IRB00074978-RCT
- Conditions
- Child Health, Text Messaging
- Keywords
- child health, well child visits, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reminder | Experimental | Other: Text message remindersParticipants will be sent a text message reminder of their missed well-child visit. |
| Treatment as usual | No intervention | –This group will receive treatment as usual, which involves no text messaging follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message remindersText messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits. | Other | Reminder |
Primary outcome
Number of rescheduled well child visits
Time frame: 6 weeks after missed well child visit
If parent/guardian rescheduled 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
2 secondary outcomes
Number of child patient emergency department visits
Time frame: 6 weeks after missed well child visit
Number of child patient hospitalizations
Time frame: 6 weeks after missed well child visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 38852906Debinski 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.
- Individual participant dataSharing planned: No
Related trials for Child Health
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children
Infant Allergy, Infant Gut Health
Active, not recruiting
AI-Assisted Child Health Podcast Education for Nursing Students
Nursing Education
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Poehling, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message reminders in people with Child Health and Text Messaging, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of rescheduled well child visits (time frame: 6 weeks after missed well child visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.