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Impact of Serious Pediatric Illness on Parent and Sibling Health

Impact of Serious Pediatric Illness on Parent and Sibling Health

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03971344
Enrollment
161000
Registered
2019-06-03
Start date
2020-01-30
Completion date
2020-07-31
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Members of: Children Severe Neurological Impairment, Family Members of: Critical Congenital Heart Defect Patients, Family Members of: Newborns Extremely Premature, Family Members of: New Pediatric Oncology Patients

Brief summary

To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family.

Detailed description

Although standard pediatric practice, when caring for a child with serious illness, is to provide support to the child's parents and any siblings, little quantitative information exists regarding what could be considered the collateral impact on other family members of having a child with serious illness in the family. This study seeks to provide such information, using existing claims data from the health insurance company, Cigna, to identify children with serious illness and then examining the health and health care of their family members. The investigators hypothesize that, compared to control families without a sick child, parents and siblings of children with serious pediatric illness (SPI) will have more new mental and physical health diagnoses, more new prescriptions, increased levels of Emergency Department (ED) and acute care services, and reduced levels of use of recommended chronic disease management for pre-existing conditions and of preventative services.

Interventions

None listed

Sponsors

Cigna Foundation
CollaboratorUNKNOWN
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Cigna customers as follows: 1. Neonatal Intensive Care Unit (NICU) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams. 2. Critical Congenital Heart Disease (CCHD) cohort: Newborns with critical congenital heart defects who undergo surgery by 12 months of life. 3. Oncology cohort: Patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer. 4. Severe Neurological Impairment (NI) cohort: Patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans. * For each index patient in a particular SPI cohort, Investigators randomly identified up to four children of the same ages as the index patient but who do not have the specific SPI. The matching by age was as follows: in months if \< 3 years; and in years if age \> or = 3 years. Cigna then identified all family members, using both definitions of family members described above.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
New physical health prescriptions among siblings3 yearsOutcome will be assessed based on prescription data in de-identified claims data
New mental health diagnoses among parents3 yearsOutcome will be assessed based on diagnoses in de-identified claims data
New mental health diagnoses among siblings3 yearsOutcome will be assessed based on diagnoses in de-identified claims data
New physical health diagnoses among parents3 yearsOutcome will be assessed based on diagnoses in de-identified claims data
New physical health diagnoses among siblings3 yearsOutcome will be assessed based on diagnoses in de-identified claims data
New mental health prescriptions among parents3 yearsOutcome will be assessed based on prescription data in de-identified claims data
New mental health prescriptions among siblings3 yearsOutcome will be assessed based on prescription data in de-identified claims data
New physical health prescriptions among parents3 yearsOutcome will be assessed based on prescription data in de-identified claims data

Secondary

MeasureTime frameDescription
Emergency department usage among parents3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Emergency department usage among siblings3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Ambulatory care usage among parents3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Ambulatory care usage among siblings3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Hospitalizations among parents3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Hospitalizations among siblings3 yearsOutcome will be assessed based on encounter data in de-identified claims data
Adherence to chronic disease management standards among parents3 yearsOutcome will be assessed based on data in de-identified claims data
Receipt of well-child visit and childhood immunizations among siblings3 yearsOutcome will be assessed based on data in de-identified claims data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026