Children and Youth With Special Healthcare NeedsNCT05056480
Learning Health for Pediatric Complex Care Integration (PCCI)
An observational study of Children and Youth With Special Healthcare Needs and Care Coordination, run by Duke University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Children and Youth With Special Healthcare Needs, Care Coordination
- What is being tested?
- Surveys
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Surveys
- Keywords
- Care coordination, Complex care, Interdisciplinary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Also called Interviews
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents/caregivers | Parents/caregivers of children <20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program Receives: Other: Surveys | |
| Clinical staff | PCCI care management staff participating in implementation of the PCCI program Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start24 Mar 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children and Youth With Special Healthcare NeedsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Y Ming, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056480
- Sponsor's protocol ID
- Pro00104642
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Health for Pediatric Complex Care Integration (PCCI)
- ClinicalTrials.gov ID
- NCT05056480
- Acronym / sponsor ID
- Pro00104642
- Keywords
- Care coordination, Complex care, Interdisciplinary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents/caregivers | – | Other: SurveysParents/caregivers of children <20 years old who received interdisciplinary care coordination within the Pediatric Complex Care Integration (PCCI) program |
| Clinical staff | – | Other: SurveysPCCI care management staff participating in implementation of the PCCI program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Exclusion criteria for children and parents/caregivers: children/parents will be excluded if they meet the below criteria:
- Inclusion criteria for clinical staff and providers (participation in interviews and quantitative staff/provider-reported surveys):
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysAlso: InterviewsParent/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 | Clinical staff, Parents/caregivers |
Primary outcome
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).
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.
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).
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).
8 secondary outcomes
Change in caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
Time frame: 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
Change in perceptions of cultural distance, as measured by the Cultural Distance Scale (CDS)
Time frame: 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
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
Feasibility, as measured by clinical staff survey
Time frame: 12 months
Acceptability, as measured by clinical staff survey
Time frame: 12 months
Appropriateness, as measured by clinical staff survey
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Patient Navigation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Y Ming, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Youth With Special Healthcare Needs and Care Coordination, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in care fragmentation, as measured by the Pediatric Integrated Care Survey (PICS) (time frame: Baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.