Skip to main content
Clinical Trials/NCT03971344
NCT03971344
Completed
Not Applicable

Impact of Serious Pediatric Illness on Parent and Sibling Health

Children's Hospital of Philadelphia1 site in 1 country161,000 target enrollmentJanuary 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Family Members of: Newborns Extremely Premature
Sponsor
Children's Hospital of Philadelphia
Enrollment
161000
Locations
1
Primary Endpoint
New mental health diagnoses among parents
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2020
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Cigna customers as follows:
  • Neonatal Intensive Care Unit (NICU) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams.
  • Critical Congenital Heart Disease (CCHD) cohort: Newborns with critical congenital heart defects who undergo surgery by 12 months of life.
  • Oncology cohort: Patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer.
  • 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

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Emergency department usage among parents(3 years)
  • Emergency department usage among siblings(3 years)
  • Ambulatory care usage among parents(3 years)
  • Ambulatory care usage among siblings(3 years)
  • Hospitalizations among parents(3 years)
  • Hospitalizations among siblings(3 years)
  • Adherence to chronic disease management standards among parents(3 years)
  • Receipt of well-child visit and childhood immunizations among siblings(3 years)

Study Sites (1)

Loading locations...

Similar Trials