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Clinical Trials/NCT05056480
NCT05056480
Completed
Not Applicable

Learning Health for Pediatric Complex Care Integration (PCCI)

Duke University1 site in 1 country20 target enrollmentMarch 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children and Youth With Special Healthcare Needs
Sponsor
Duke University
Enrollment
20
Locations
1
Primary Endpoint
Change in parent health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2021
End Date
October 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in parent health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey

Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The PROMIS Global Health Survey is a 10-item parent-reported survey that gathers parent perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).

Change in care fragmentation, as measured by the Pediatric Integrated Care Survey (PICS)

Time Frame: Baseline, 6 months, 12 months

The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).

Change in child health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey

Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.

Change in well-being, as measured by the Well-Being Index (WBI)

Time Frame: Baseline, 3 months, 6 months, 12 months

The Well-Being Index is a 9-time clinical provider/staff-reported measure that gathers staff perceptions of their overall well-being at work. Seven of the 9 survey items use a dichotomous response (Yes/No) and two remaining items use 7-level Likert scale (1=very strongly disagree; 7=very strongly agree).

Secondary Outcomes

  • Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)(Baseline, 3 months, 6 months, 12 months)
  • Change in perceptions of barriers to care, as measured by the Barriers to Care Questionnaire (BCQ)(Baseline, 12 months)
  • Acceptability, as measured by clinical staff survey(12 months)
  • Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS)(Baseline, 12 months)
  • Changes in caregiver self-efficacy, as measured by the New Generalized Self-Efficacy Scale (NGSE)(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Changes in perceptions of shared decision-making, as measured by the a sub-scale from the Interpersonal Processes of Care survey(3 months, 6 months, 9 months, 12 months)
  • Feasibility, as measured by clinical staff survey(12 months)
  • Appropriateness, as measured by clinical staff survey(12 months)

Study Sites (1)

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