Learning Health for Pediatric Complex Care Integration (PCCI)

October 11, 2022 updated by: Duke University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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.
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
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).
Baseline, 3 months, 6 months, 9 months, 12 months
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).
Baseline, 3 months, 6 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
Time Frame: 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).
Baseline, 3 months, 6 months, 12 months
Change in perceptions of barriers to care, as measured by the Barriers to Care Questionnaire (BCQ)
Time Frame: 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).
Baseline, 12 months
Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS)
Time Frame: 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).
Baseline, 12 months
Changes in caregiver self-efficacy, as measured by the New Generalized Self-Efficacy Scale (NGSE)
Time Frame: 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).
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
Time Frame: 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).
3 months, 6 months, 9 months, 12 months
Feasibility, as measured by clinical staff survey
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Y Ming, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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