ClinicalTrials.Veeva

Menu

Learning Health for Pediatric Complex Care Integration (PCCI)

Duke University logo

Duke University

Status

Completed

Conditions

Children and Youth With Special Healthcare Needs
Care Coordination

Treatments

Other: Surveys

Study type

Observational

Funder types

Other

Identifiers

NCT05056480
Pro00104642

Details and patient eligibility

About

The study team will conduct a mixed methods evaluation of the implementation of an evidence-based clinical program -- the Pediatric Complex Care Integration (PCCI) program - for improvement of care integration for children and youth with special healthcare needs (CYSHCN) and children with medical complexity (CMC). The PCCI program is not a discrete intervention itself; rather it is a health system-initiated program that will be implemented as a new standard of care for eligible patients with the intention of improving quality of care, implemented by clinical teams within Duke Health.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Inclusion criteria for children and parents/caregivers:

    • Patients up to 20 years old or under at the time of the monthly data pull or clinical team recommendation (for participation in the PCCI clinical program; no minors under 18 years old will be directly surveyed)
    • Adult parents/caregivers of participating children (for participation in interviews and quantitative parent-reported surveys) *For human-centered design interviews, PCCI program participation is not required
    • Primary care attributed to Duke Pediatrics Primary Care - Roxboro Road clinic
    • High level of medical complexity: CSHCN (level 2 PMCA) or CMC (level 3 PMCA)
    • High risk for future healthcare utilization - may be defined by provider/care team determination, EHR data-based risk prediction model (exempt IRB Pro00104983, Developing a Model to Predict Risk for Healthcare Utilization by Children with Chronic Conditions), or any other way in which the clinical team determines a patient is "high risk" as part of their standard practice/care.
  • Exclusion criteria for children and parents/caregivers: children/parents will be excluded if they meet the below criteria:

    • Unable to provide informed consent
    • Non-English or Spanish speaking parent/caregiver or young adult patient
  • Inclusion criteria for clinical staff and providers (participation in interviews and quantitative staff/provider-reported surveys):

    • Currently employed by Duke Health
    • Primary site of work at participating primary care clinic site or central DUHS PHMO

Trial design

20 participants in 2 patient groups

Parents/caregivers
Description:
Parents/caregivers of children \<20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program
Treatment:
Other: Surveys
Clinical staff
Description:
PCCI care management staff participating in implementation of the PCCI program
Treatment:
Other: Surveys

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems