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Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit

Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06686849
Enrollment
3846
Registered
2024-11-13
Start date
2025-01-09
Completion date
2026-04-07
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-child Care Visits

Keywords

Well-Child care, Community Health Workers, Missed healthcare appointments, Text message follow-up

Brief 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). 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.

Interventions

BEHAVIORALLow-touch: texting

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.

BEHAVIORALHigh-touch: Community health worker outreach

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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\- Already rescheduled their appointment by the time the sample list was generated

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients of All Ages with any Completed Well-Child VisitsWeek 6 post missed well-child visitWhether 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 VisitsWeek 6 post missed well-child visitWhether 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 VisitsWeek 6 post missed well-child visitWhether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention

Secondary

MeasureTime frameDescription
Proportion of Patients of All Ages with Any Rescheduled Well-Child VisitWeek 6 post missed well-child visitWhether any Well-Child visit was rescheduled by each patient (yes/no) following usual care, text intervention or community health worker intervention
Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child VisitMonth 3 post missed well-child visitWhether any Well-Child visit was rescheduled by each patient (yes/no) following usual care, text intervention or community health worker intervention
Proportion of Patients of All Ages with Vaccination status up-to-date6 weeks post missed well-child visitWhether each patient is up-to-date on all age-appropriate vaccinations (yes/no)
Proportion of Patients 3 Years and Older with Vaccination status up-to-dateMonth 3 post missed well-child visitWhether each patient is up-to-date on all age-appropriate vaccinations (yes/no)
Proportion of Patients of All Ages with Any Completed Encounter6 weeks post missed well-child visitWhether each patient had any completed healthcare encounter within the same health system (yes/no)
Proportion of Patients 3 Years and Older with Any Completed EncounterMonth 3 post missed well-child visitWhether each patient had any completed healthcare encounter within the same health system (yes/no)
Proportion of Patients of All Ages with Any Non-Well-Child Primary Care Visit6 weeks post missed well-child visitWhether each patient had any completed non-Well-Child primary healthcare visit within the same health system (yes/no)
Proportion of Patients 3 Years and Older with Any Non-Well-Child Visit Primary Care VisitMonth 3 post missed well-child visitWhether each patient had any completed non-Well-Child primary healthcare visit within the same health system (yes/no)
Proportion of Patients of All Ages with Any Specialist Visit6 weeks post missed well-child visitWhether each patient had any completed non-Well-Child specialist visit within the same health system (yes/no)
Proportion of Patients 3 Years and Older with Any Specialist VisitMonth 3 post missed well-child visitWhether each patient had any completed non-Well-Child specialist visit within the same health system (yes/no)
Proportion of Patients of All Ages with Any Emergency Department Visit6 weeks post missed well-child visitWhether each patient had any Emergency Department visit within the same health system (yes/no)
Proportion of Patients 3 Years and Older with Any Emergency Department VisitMonth 3 post missed well-child visitWhether each patient had any Emergency Department within the same health system (yes/no)
Proportion of Patients of All Ages with Any Hospitalization6 weeks post missed well-child visitWhether each patient had any hospitalization within the same health system (yes/no)
Proportion of Patients 3 Years and Older with Any HospitalizationMonth 3 post missed well-child visitWhether each patient had any hospitalization within the same health system (yes/no)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBeata Debinski, PhD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026