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

NCT ID: NCT06686849

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 5885 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2026-04-30

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.

Conditions

Well-child Care Visits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Care as Usual

In the comparison group, patients' caregivers will not be subject to any standardized follow-up procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low-touch: Text messaging only

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.

Group Type: EXPERIMENTAL

Low-touch: texting

Intervention Type: 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.

High-touch: Community Health Worker outreach

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.

Group Type: EXPERIMENTAL

High-touch: Community health worker outreach

Intervention Type: 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.

Interventions

Low-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.

Intervention Type: BEHAVIORAL

High-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beata Debinski, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

1R21MD019434-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00118696

Identifier Type: -

Identifier Source: org_study_id