Impact of Serious Pediatric Illness on Parent and Sibling Health

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 Overview

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

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 Type: Observational
• Enrollment (Actual): 161000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

See Eligibility Criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Cigna Foundation
• Investigators: Principal Investigator: Chris Feudtner, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: FP00024612

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No