Learning Health for Pediatric Complex Care Integration (PCCI)

NCT05056480 | Completed

• 1 other identifier: Pro00104642
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Children and Youth With Special Healthcare Needs; Care Coordination

Keywords

Care coordination; Complex care; Interdisciplinary care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

• 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

Study Arms (2)

Parents/caregivers

Parents/caregivers of children \<20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program

Other: Surveys

Clinical staff

PCCI care management staff participating in implementation of the PCCI program

Other: Surveys

Interventions

Surveys OTHER

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.

Also known as: Interviews

Clinical staff; Parents/caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide informed consent
• Non-English or Spanish speaking parent/caregiver or young adult patient
• Currently employed by Duke Health
• Primary site of work at participating primary care clinic site or central DUHS PHMO

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David Y Ming, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 24, 2021
• Study Start: March 24, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)