Learning Health for Pediatric Complex Care Integration (PCCI)
- Conditions
- Children and Youth With Special Healthcare NeedsCare Coordination
- Interventions
- Other: Surveys
- Registration Number
- NCT05056480
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parents/caregivers Surveys Parents/caregivers of children \<20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program Clinical staff Surveys PCCI care management staff participating in implementation of the PCCI program
- Primary Outcome Measures
Name Time Method Change in parent health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey 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) 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 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) 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 Outcome Measures
Name Time Method Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM) Baseline, 3 months, 6 months, 12 months The Parent-Patient Activation Measure (P-PAM) is a 13-item parent-reported survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Change in perceptions of barriers to care, as measured by the Barriers to Care Questionnaire (BCQ) Baseline, 12 months The 19-item Barriers to Care Questionnaire (BCQ) gathers parent perspectives on barriers encountered when trying to get health care for their child. The BCQ uses a 5-level Likert scale (0=never; 4=almost always).
Acceptability, as measured by clinical staff survey 12 months Perceptions of the acceptability of implementation of the PCCI care management program, as measured by the Acceptability of Intervention Measure (AIM)
Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS) Baseline, 12 months The 4-item Cultural Distance Scale (CDS) is a parent-reported survey that uses a 6-level Likert scale (1=very similar; 6=very different).
Changes in caregiver self-efficacy, as measured by the New Generalized Self-Efficacy Scale (NGSE) Baseline, 3 months, 6 months, 9 months, 12 months The 8-item New Generalized Self-Efficacy Scale is a parent-reported survey uses a 5-level Likert scale (1=strongly disagree; 5=strongly agree).
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 This 4-item sub-scale from the Interpersonal Processes of Care survey focuses on perceptions of shared-decision making. Parents respond to questions on a 5-level Likert scale (1=never; 5=always).
Feasibility, as measured by clinical staff survey 12 months Perceptions of the feasibility of implementation of the PCCI care management program, as measured by the Feasbility of Intervention Measure (FIM)
Appropriateness, as measured by clinical staff survey 12 months Perceptions of the appropriateness of implementation of the PCCI care management program, as measured by the Intervention Appropriateness Measure (IAM)
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States