Learning Health for Pediatric Complex Care Integration (PCCI)

Care Coordination Clinical Trial

Official title:

Learning Health for Pediatric Complex Care Integration (PCCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056480
• Other study ID #: Pro00104642
• Status: Completed
• Start date: March 24, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Care Coordination

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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