Well-child Care VisitsNCT06686849
Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit
A study testing Low-touch: texting and High-touch: Community health worker outreach in people with Well-child Care Visits, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The overall goal of this study is to compare the effectiveness of different follow up protocols for scheduled but not attended ("no-show") Well-Child Visits, relative to care-as-usual (no standardized or typical follow up procedure). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Well-child Care Visits
- What is being tested?
- Low-touch: texting and High-touch: Community health worker outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,846 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 7 Apr 2026
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Are 0-17 years
- No-showed for a well-child visit scheduled at a family medicine or general pediatrics practice in Forsyth County, North Carolina
- Have a phone number on record for a primary caregiver
- With primary language for contact that is English or Spanish
Who cannot join
- Already rescheduled their appointment by the time the sample list was generated
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Family and Community Medicine, Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
The overall goal of this study is to compare the effectiveness of different follow up protocols for scheduled but not attended ("no-show") Well-Child Visits, relative to care-as-usual (no standardized or typical follow up procedure). The main goals are to:
- Demonstrate feasibility of merging a new referral protocol following Well-Child visit no-show into existing health system Community Health Worker resources.
- Compare Well-Child Visit attendance following no-show between patients randomized to care-as-usual (comparison), text message only (low-touch intervention), and community health worker outreach (high-touch intervention) groups.
- Define the costs and cost-effectiveness of different follow-up protocols.
Read the detailed description
Well-Child visits (WCV) are at the core of preventive care in pediatrics. These Visits are an important opportunity for patients to be engaged with the healthcare system, for assessing child health and development, and for screening and counseling for prevention. Missed WCVs have been associated with negative health outcomes as well as avoidable healthcare costs and may occur for a variety of different reasons. There is room for improving follow-up with families to re-engage patients after not attending a scheduled WCV ("no-show"). This study will test and compare a text messaging intervention and community health worker outreach intervention to care-as-usual (no standard follow-up) as strategies for proactively engaging families in care after no-show to promote rescheduling and visit attendance. Evaluating effectiveness and cost-effectiveness of both interventions will inform clinical practice and decision-making in healthcare to help ultimately improve pediatric preventive care.
- Conditions
- Well-child Care Visits
- Being tested
- Low-touch: texting, High-touch: Community health worker outreach
- Keywords
- Well-Child care, Community Health Workers, Missed healthcare appointments, Text message follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-touch: textingBehavioural
Text message: The patients' primary caregiver will be sent up to three text messages spaced one week apart, starting at one week post no-show. The message will identify the child by the first name and give information about the missed visit (date, time, clinic location) and how to reschedule (by clinic-specific phone number, and/or directing the patient to myatriumhealth.org). If a patient has a newly scheduled well-child visit on file prior to all three text messages being sent, messages will be stopped.
High-touch: Community health worker outreachBehavioural
Community health worker (CHW) outreach: Within approximately one week of patient enrollment and randomization to the high-touch intervention arm, the community health worker will call the primary phone number in the patient's record. Up to three phone call attempts will be made and logged for this number, then a fourth and final attempt will be made to reach the secondary contact phone number in the patient's health record. If the caregiver is successfully reached, the CHW intervention will be limited to one phone call in which the CHW will assess reason(s) why the patient missed the appointment, will screen for social and other needs, and will assist in rescheduling the missed appointment and addressing potential barriers to attendance.
| Study group | Role | What they receive |
|---|---|---|
| Care as Usual | No intervention | In the comparison group, patients' caregivers will not be subject to any standardized follow-up procedure. |
| Low-touch: Text messaging only | Experimental | The patients' primary caregiver will receive a text message that includes details about the missed appointment, and guidance on rescheduling. Up to three total reminders will be sent, spaced one week apart, if the appointment is not rescheduled in the interim. Receives: Behavioral: Low-touch: texting |
| High-touch: Community Health Worker outreach | Experimental | Regardless of rescheduling status, the Community Health Worker (CHW) will reach out to the primary phone number on file within approximately 1 week of enrollment in the study. Per usual team protocol, up to three phone call attempts will be made to the primary phone number on file, followed by an attempt to the secondary phone number on file. The CHW will screen the families' needs per their usual protocol and inquire about reasons for no-showing for the scheduled appointment; additional questions will include whether they can provide support for rescheduling the no-showed visit and helping to attend it. The CHW will also have a discretionary fund available through this project to help support the family in addressing instrumental needs if existing resources are not available through the hospital, governmental services, or other organizations. Receives: Behavioral: High-touch: Community health worker outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients of All Ages with any Completed Well-Child Visits
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Week 6 post missed well-child visit
Proportion of Patients Under 3 Years Old with any Completed Well-Child Visits
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Week 6 post missed well-child visit
Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Week 6 post missed well-child visit
Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Month 3 post missed well-child visit
Secondary outcomes (14)
Proportion of Patients of All Ages with Any Rescheduled Well-Child Visit
Whether any Well-Child visit was rescheduled by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Week 6 post missed well-child visit
Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child Visit
Whether any Well-Child visit was rescheduled by each patient (yes/no) following usual care, text intervention or community health worker intervention
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Vaccination status up-to-date
Whether each patient is up-to-date on all age-appropriate vaccinations (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Vaccination status up-to-date
Whether each patient is up-to-date on all age-appropriate vaccinations (yes/no)
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Completed Encounter
Whether each patient had any completed healthcare encounter within the same health system (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Completed Encounter
Whether each patient had any completed healthcare encounter within the same health system (yes/no)
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Non-Well-Child Primary Care Visit
Whether each patient had any completed non-Well-Child primary healthcare visit within the same health system (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Non-Well-Child Visit Primary Care Visit
Whether each patient had any completed non-Well-Child primary healthcare visit within the same health system (yes/no)
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Specialist Visit
Whether each patient had any completed non-Well-Child specialist visit within the same health system (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Specialist Visit
Whether each patient had any completed non-Well-Child specialist visit within the same health system (yes/no)
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Emergency Department Visit
Whether each patient had any Emergency Department visit within the same health system (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Emergency Department Visit
Whether each patient had any Emergency Department within the same health system (yes/no)
Measured: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Hospitalization
Whether each patient had any hospitalization within the same health system (yes/no)
Measured: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Hospitalization
Whether each patient had any hospitalization within the same health system (yes/no)
Measured: Month 3 post 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 posted13 Nov 2024
- Study start9 Jan 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-child Care VisitsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Beata Debinski, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686849
- Sponsor's protocol ID
- IRB00118696
- Other IDs
- 1R21MD019434-01A1
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will preserve and share predominantly transformed analytical variables, or de-identified patient data about: * study arm assignment * preferred language of care (English/Spanish) * prior Well-child visit in previous 2 years (yes/no) * age in years * racial categorization * ethnicity * insurance status (categorized into private, public, or uninsured) -# of siblings who no-showed in study period * unique identifier for each patient * unique identifier for each household * qualifying Well-child visit no-show encounter-level data that will be shared will be a unique identifier for the clinic location, time of visit, and a week of the year (1-52) instead of date of visit to reduce identifiability but provide information about relative time of year and season * dichotomized outcome data on subsequent healthcare encounters * dichotomized or categorized Community Health Worker-generated data (high-touch intervention group only)
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit
- ClinicalTrials.gov ID
- NCT06686849
- Acronym / sponsor ID
- IRB00118696
- Conditions
- Well-child Care Visits
- Keywords
- Well-Child care, Community Health Workers, Missed healthcare appointments, Text message follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,846 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 13 Nov 2024 (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.
The overall goal of this study is to compare the effectiveness of different follow up protocols for scheduled but not attended ("no-show") Well-Child Visits, relative to care-as-usual (no standardized or typical follow up procedure). The main goals are to:
- Demonstrate feasibility of merging a new referral protocol following Well-Child visit no-show into existing health system Community Health Worker resources.
- Compare Well-Child Visit attendance following no-show between patients randomized to care-as-usual (comparison), text message only (low-touch intervention), and community health worker outreach (high-touch intervention) groups.
- Define the costs and cost-effectiveness of different follow-up protocols.
Detailed description
Well-Child visits (WCV) are at the core of preventive care in pediatrics. These Visits are an important opportunity for patients to be engaged with the healthcare system, for assessing child health and development, and for screening and counseling for prevention. Missed WCVs have been associated with negative health outcomes as well as avoidable healthcare costs and may occur for a variety of different reasons. There is room for improving follow-up with families to re-engage patients after not attending a scheduled WCV ("no-show"). This study will test and compare a text messaging intervention and community health worker outreach intervention to care-as-usual (no standard follow-up) as strategies for proactively engaging families in care after no-show to promote rescheduling and visit attendance. Evaluating effectiveness and cost-effectiveness of both interventions will inform clinical practice and decision-making in healthcare to help ultimately improve pediatric preventive care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | No intervention | –In the comparison group, patients' caregivers will not be subject to any standardized follow-up procedure. |
| Low-touch: Text messaging only | Experimental | Behavioral: Low-touch: textingThe patients' primary caregiver will receive a text message that includes details about the missed appointment, and guidance on rescheduling. Up to three total reminders will be sent, spaced one week apart, if the appointment is not rescheduled in the interim. |
| High-touch: Community Health Worker outreach | Experimental | Behavioral: High-touch: Community health worker outreachRegardless of rescheduling status, the Community Health Worker (CHW) will reach out to the primary phone number on file within approximately 1 week of enrollment in the study. Per usual team protocol, up to three phone call attempts will be made to the primary phone number on file, followed by an attempt to the secondary phone number on file. The CHW will screen the families' needs per their usual protocol and inquire about reasons for no-showing for the scheduled appointment; additional questions will include whether they can provide support for rescheduling the no-showed visit and helping to attend it. The CHW will also have a discretionary fund available through this project to help support the family in addressing instrumental needs if existing resources are not available through the hospital, governmental services, or other organizations. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Are 0-17 years
- No-showed for a well-child visit scheduled at a family medicine or general pediatrics practice in Forsyth County, North Carolina
- Have a phone number on record for a primary caregiver
- With primary language for contact that is English or Spanish
Key exclusion criteria (1 listed)
- Already rescheduled their appointment by the time the sample list was generated
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 |
|---|---|---|
| Low-touch: textingText message: The patients' primary caregiver will be sent up to three text messages spaced one week apart, starting at one week post no-show. The message will identify the child by the first name and give information about the missed visit (date, time, clinic location) and how to reschedule (by clinic-specific phone number, and/or directing the patient to myatriumhealth.org). If a patient has a newly scheduled well-child visit on file prior to all three text messages being sent, messages will be stopped. | Behavioural | Low-touch: Text messaging only |
| High-touch: Community health worker outreachCommunity health worker (CHW) outreach: Within approximately one week of patient enrollment and randomization to the high-touch intervention arm, the community health worker will call the primary phone number in the patient's record. Up to three phone call attempts will be made and logged for this number, then a fourth and final attempt will be made to reach the secondary contact phone number in the patient's health record. If the caregiver is successfully reached, the CHW intervention will be limited to one phone call in which the CHW will assess reason(s) why the patient missed the appointment, will screen for social and other needs, and will assist in rescheduling the missed appointment and addressing potential barriers to attendance. | Behavioural | High-touch: Community Health Worker outreach |
Primary outcome
Proportion of Patients of All Ages with any Completed Well-Child Visits
Time frame: Week 6 post missed well-child visit
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Proportion of Patients Under 3 Years Old with any Completed Well-Child Visits
Time frame: Week 6 post missed well-child visit
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
Time frame: Week 6 post missed well-child visit
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
Time frame: Month 3 post missed well-child visit
Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention
14 secondary outcomes
Proportion of Patients of All Ages with Any Rescheduled Well-Child Visit
Time frame: Week 6 post missed well-child visit
Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child Visit
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Vaccination status up-to-date
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Vaccination status up-to-date
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Completed Encounter
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Completed Encounter
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Non-Well-Child Primary Care Visit
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Non-Well-Child Visit Primary Care Visit
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Specialist Visit
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Specialist Visit
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Emergency Department Visit
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Emergency Department Visit
Time frame: Month 3 post missed well-child visit
Proportion of Patients of All Ages with Any Hospitalization
Time frame: 6 weeks post missed well-child visit
Proportion of Patients 3 Years and Older with Any Hospitalization
Time frame: Month 3 post 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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will preserve and share predominantly transformed analytical variables, or de-identified patient data about: * study arm assignment * preferred language of care (English/Spanish) * prior Well-child visit in previous 2 years (yes/no) * age in years * racial categorization * ethnicity * insurance status (categorized into private, public, or uninsured) -# of siblings who no-showed in study period * unique identifier for each patient * unique identifier for each household * qualifying Well-child visit no-show encounter-level data that will be shared will be a unique identifier for the clinic location, time of visit, and a week of the year (1-52) instead of date of visit to reduce identifiability but provide information about relative time of year and season * dichotomized outcome data on subsequent healthcare encounters * dichotomized or categorized Community Health Worker-generated data (high-touch intervention group only)
Related trials for Well-child Care Visits
Recruiting
Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care Services
Pediatric, Well Child Care
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.
Beata Debinski, PhD 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 Low-touch: texting and High-touch: Community health worker outreach in people with Well-child Care Visits, 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 4 inclusion and 1 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 28 Jul 2026. 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?
Proportion of Patients of All Ages with any Completed Well-Child Visits (time frame: Week 6 post missed well-child visit). The study lists 4 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 28 Jul 2026.