Clinical trial NCT05056480: Learning Health for Pediatric Complex Care Integration (PCCI)
Official title: Learning Health for Pediatric Complex Care Integration (PCCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children and Youth With Special Healthcare Needs
Care Coordination
Keywords: Care coordination
Complex care
Interdisciplinary care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult parents/caregivers of children/youth who have primary care attributed to Duke Pediatrics Primary Care - Roxboro Road clinic and are receiving complex care management within the PCCI clinical program.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in care fragmentation, as measured by the Pediatric Integrated Care Survey (PICS)
timeFrame: Baseline, 6 months, 12 months
measure: Change in child health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in parent health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in well-being, as measured by the Well-Being Index (WBI)
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in perceptions of barriers to care, as measured by the Barriers to Care Questionnaire (BCQ)
timeFrame: Baseline, 12 months
measure: Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS)
timeFrame: Baseline, 12 months
measure: Changes in caregiver self-efficacy, as measured by the New Generalized Self-Efficacy Scale (NGSE)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Changes in perceptions of shared decision-making, as measured by the a sub-scale from the Interpersonal Processes of Care survey
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Feasibility, as measured by clinical staff survey
timeFrame: 12 months
measure: Acceptability, as measured by clinical staff survey
timeFrame: 12 months
measure: Appropriateness, as measured by clinical staff survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Health
name: David Y Ming, MD
role: PRINCIPAL_INVESTIGATOR
References: