Clinical trial NCT06686849: Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit
Official title: Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Well-child Care Visits
Keywords: Well-Child care
Community Health Workers
Missed healthcare appointments
Text message follow-up
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-11-13
Enrollment: 5885
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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
* Caregiver is not 18 years or older

Primary outcomes:
measure: Proportion of Patients of All Ages with any Completed Well-Child Visits
timeFrame: Week 6 post missed well-child visit
measure: Proportion of Patients Under 3 Years Old with any Completed Well-Child Visits
timeFrame: Week 6 post missed well-child visit
measure: Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
timeFrame: Week 6 post missed well-child visit
measure: Proportion of Patients 3 Years and Older with any Completed Well-Child Visits
timeFrame: Month 3 post missed well-child visit
Secondary outcomes:
measure: Proportion of Patients of All Ages with Any Rescheduled Well-Child Visit
timeFrame: Week 6 post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child Visit
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Vaccination status up-to-date
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Vaccination status up-to-date
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Any Completed Encounter
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Completed Encounter
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Any Non-Well-Child Primary Care Visit
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Non-Well-Child Visit Primary Care Visit
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Any Specialist Visit
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Specialist Visit
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Any Emergency Department Visit
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Emergency Department Visit
timeFrame: Month 3 post missed well-child visit
measure: Proportion of Patients of All Ages with Any Hospitalization
timeFrame: 6 weeks post missed well-child visit
measure: Proportion of Patients 3 Years and Older with Any Hospitalization
timeFrame: Month 3 post missed well-child visit
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Department of Family and Community Medicine, Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Beata Debinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: