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

NCT06686849 | Completed DMC

• 2 other identifiers: IRB001186961R21MD019434-01A1
• Study Type: interventional
• Target: 3,846
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-child Care Visits

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Month 3 post missed well-child visit

Secondary Outcomes (14)

• Proportion of Patients of All Ages with Any Rescheduled Well-Child Visit

  Week 6 post missed well-child visit

• Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child Visit

  Month 3 post missed well-child visit

• Proportion of Patients of All Ages with Vaccination status up-to-date

  6 weeks post missed well-child visit

• Proportion of Patients 3 Years and Older with Vaccination status up-to-date

  Month 3 post missed well-child visit

• Proportion of Patients of All Ages with Any Completed Encounter

  6 weeks post missed well-child visit

Study Arms (3)

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.

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.

Behavioral: High-touch: Community health worker outreach

Interventions

Low-touch: texting BEHAVIORAL

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.

Low-touch: Text messaging only

High-touch: Community health worker outreach BEHAVIORAL

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.

High-touch: Community Health Worker outreach

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Department of Family and Community Medicine, Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Beata Debinski, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: January 9, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: July 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data from the first six months of trial enrollment will be deposited approximately nine months after the enrollment begins. A complete dataset for the full twelve months of enrollment will be deposited by six months after enrollment is completed. As data will be deposited to open Inter-University Consortium for Political \& Social Research (openICPSR), it will be published and immediately available to the public. Data will be available on openICPSR permanently.
• Access Criteria: The study protocol and codebooks (with variable-level details) will be made available as PDFs on the openICPSR website along with the data. openICPSR will also release metadata about the project that adheres to the Data Documentation Initiative (DDI) disciplinary metadata standard. The only requirements to access downloadable, de-identified data through ICPSR are user registration and agreement to ICPSR's Terms of Use, which require users to agree to not redisseminate data, to use appropriate data citation, and to maintain human subjects protections.

Locations

US (1)