Impact of Serious Pediatric Illness on Parent and Sibling Health

Completed

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

• Registration Number: NCT03971344
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Study Start: 2020-01-30
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States