Child HealthNCT05189080
Twilio Well-Child Visit Pilot Open Trial
A study testing Text message reminders, Interviews and Survey 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 no-showed for WCVs. 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, Interviews and Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 8 Apr 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: Open 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 no-showed for WCVs. The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. These findings will be used to conduct the second phase of the study, a randomized controlled trial.
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, Interviews, Survey
- 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 no-showed for their well child visits.
InterviewsOther
Interviews will be conducted with a subset of participants to identify the top one or two performing text messages.
SurveyOther
Alongside notification text messages regarding no-showed visits, participants will be invited to participate in a survey about their experience with the health system. This survey will assess reasons for missing the WCV and primary caregiver's perspective on the experience at the prior visit.
| Study group | Role | What they receive |
|---|---|---|
| Open Trial | Experimental | Patients within the Wake Forest Baptist Health system who no-showed for scheduled well child visits at Pediatrics-Downtown Health Plaza, Family Medicine-Piedmont Plaza, Pediatrics-Winston East, Family Medicine-Peace Haven, and Pediatrics-Clemmons. Receives: Other: Text message reminders; Other: Interviews; Other: Survey |
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 no-showed well child visit
Number of completed (rescheduled) well child visits
If parent/guardian completed (rescheduled) well child visit
Measured: 6 weeks after no-showed 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 no-showed well child visit
Number of child patient hospitalizations
If child patient required hospitalization
Measured: 6 weeks after no-showed 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 posted12 Jan 2022
- Study start17 Dec 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal.
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT05189080
- Sponsor's protocol ID
- IRB00074978-OT
- Status last verified
- May 2022
- First submitted
- 29 Dec 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 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: Open Trial
- ClinicalTrials.gov ID
- NCT05189080
- Acronym / sponsor ID
- IRB00074978-OT
- Conditions
- Child Health, Text Messaging
- Keywords
- child health, well child visits, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 12 Jan 2022 (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 no-showed for WCVs. The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. These findings will be used to conduct the second phase of the study, a randomized controlled trial.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal.
| Arm | Type | Receives |
|---|---|---|
| Open Trial | Experimental | Other: Text message reminders, Other: Interviews, Other: SurveyPatients within the Wake Forest Baptist Health system who no-showed for scheduled well child visits at Pediatrics-Downtown Health Plaza, Family Medicine-Piedmont Plaza, Pediatrics-Winston East, Family Medicine-Peace Haven, and Pediatrics-Clemmons. |
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 no-showed for their well child visits. | Other | Open Trial |
| InterviewsInterviews will be conducted with a subset of participants to identify the top one or two performing text messages. | Other | Open Trial |
| SurveyAlongside notification text messages regarding no-showed visits, participants will be invited to participate in a survey about their experience with the health system. This survey will assess reasons for missing the WCV and primary caregiver's perspective on the experience at the prior visit. | Other | Open Trial |
Primary outcome
Number of rescheduled well child visits
Time frame: 6 weeks after no-showed well child visit
If parent/guardian rescheduled well child visit
Number of completed (rescheduled) well child visits
Time frame: 6 weeks after no-showed 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 no-showed well child visit
Number of child patient hospitalizations
Time frame: 6 weeks after no-showed 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 6 Jul 2022.
- Individual participant dataSharing planned: No
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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, Interviews and Survey 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 6 Jul 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 no-showed 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?
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 6 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.