Impact of Serious Pediatric Illness on Parent and Sibling Health

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 31, 2020

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.

Arms, Groups and Cohorts

  • Family members of newborns extremely premature
    • Parents and siblings (if any) of infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams.
  • Family members of new pediatric oncology patients
    • Parents and siblings (if any) of patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer.
  • Family members of critical congenital heart defect patients
    • Parents and siblings (if any) of newborns with critical congenital heart defects who typically undergo surgery by 12 months of life.
  • Family members of children with severe neurological impairment
    • Parents and siblings (if any) of patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans.

Clinical Trial Outcome Measures

Primary Measures

  • New mental health diagnoses among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on diagnoses in de-identified claims data
  • New mental health diagnoses among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on diagnoses in de-identified claims data
  • New physical health diagnoses among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on diagnoses in de-identified claims data
  • New physical health diagnoses among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on diagnoses in de-identified claims data
  • New mental health prescriptions among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on prescription data in de-identified claims data
  • New mental health prescriptions among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on prescription data in de-identified claims data
  • New physical health prescriptions among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on prescription data in de-identified claims data
  • New physical health prescriptions among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on prescription data in de-identified claims data

Secondary Measures

  • Emergency department usage among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Emergency department usage among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Ambulatory care usage among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Ambulatory care usage among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Hospitalizations among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Hospitalizations among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on encounter data in de-identified claims data
  • Adherence to chronic disease management standards among parents
    • Time Frame: 3 years
    • Outcome will be assessed based on data in de-identified claims data
  • Receipt of well-child visit and childhood immunizations among siblings
    • Time Frame: 3 years
    • Outcome will be assessed based on data in de-identified claims data

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Collaborator
    • Cigna Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Feudtner, MD, Principal Investigator, Children’s Hospital of Philadelphia

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