Learning Health for Pediatric Complex Care Integration (PCCI)

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.

Study Overview

• Status: Completed
• Conditions: Care Coordination; Children and Youth With Special Healthcare Needs
• Intervention / Treatment: Other: Surveys

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parents/caregivers; Parents/caregivers of children <20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program	Other: Surveys; Parent/caregivers participants will complete multiple repeating surveys to gather family-reported perspectives on the impact of the PCCI care management program. Clinical staff participants will complete multiple repeating surveys that gather clinician perspectives on the impact of the PCCI care management program. Parent/caregiver and clinical staff participants will also be invited to participated in one-on-one semi-structured interviews with the study team.; Other Names: Interviews
Clinical staff; PCCI care management staff participating in implementation of the PCCI program	Other: Surveys; Parent/caregivers participants will complete multiple repeating surveys to gather family-reported perspectives on the impact of the PCCI care management program. Clinical staff participants will complete multiple repeating surveys that gather clinician perspectives on the impact of the PCCI care management program. Parent/caregiver and clinical staff participants will also be invited to participated in one-on-one semi-structured interviews with the study team.; Other Names: Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in care fragmentation, as measured by the Pediatric Integrated Care Survey (PICS)	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).	Baseline, 6 months, 12 months
Change in child health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey	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.	Baseline, 3 months, 6 months, 9 months, 12 months
Change in parent health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey	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).	Baseline, 3 months, 6 months, 9 months, 12 months
Change in well-being, as measured by the Well-Being Index (WBI)	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).	Baseline, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)	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).	Baseline, 3 months, 6 months, 12 months
Change in perceptions of barriers to care, as measured by the Barriers to Care Questionnaire (BCQ)	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).	Baseline, 12 months
Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS)	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).	Baseline, 12 months
Changes in caregiver self-efficacy, as measured by the New Generalized Self-Efficacy Scale (NGSE)	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).	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	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).	3 months, 6 months, 9 months, 12 months
Feasibility, as measured by clinical staff survey	Perceptions of the feasibility of implementation of the PCCI care management program, as measured by the Feasbility of Intervention Measure (FIM)	12 months
Acceptability, as measured by clinical staff survey	Perceptions of the acceptability of implementation of the PCCI care management program, as measured by the Acceptability of Intervention Measure (AIM)	12 months
Appropriateness, as measured by clinical staff survey	Perceptions of the appropriateness of implementation of the PCCI care management program, as measured by the Intervention Appropriateness Measure (IAM)	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David Y Ming, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Interdisciplinary care; Care coordination; Complex care
• Other Study ID Numbers: Pro00104642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No