Impact of Serious Pediatric Illness on Parent and Sibling Health

Family Members of: Children Severe Neurological Impairment Clinical Trial

Official title:

Impact of Serious Pediatric Illness on Parent and Sibling Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971344
• Other study ID #: FP00024612
• Status: Completed
• Start date: January 30, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161000
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Cigna Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New mental health diagnoses among parents	Outcome will be assessed based on diagnoses in de-identified claims data	3 years
Primary	New mental health diagnoses among siblings	Outcome will be assessed based on diagnoses in de-identified claims data	3 years
Primary	New physical health diagnoses among parents	Outcome will be assessed based on diagnoses in de-identified claims data	3 years
Primary	New physical health diagnoses among siblings	Outcome will be assessed based on diagnoses in de-identified claims data	3 years
Primary	New mental health prescriptions among parents	Outcome will be assessed based on prescription data in de-identified claims data	3 years
Primary	New mental health prescriptions among siblings	Outcome will be assessed based on prescription data in de-identified claims data	3 years
Primary	New physical health prescriptions among parents	Outcome will be assessed based on prescription data in de-identified claims data	3 years
Primary	New physical health prescriptions among siblings	Outcome will be assessed based on prescription data in de-identified claims data	3 years
Secondary	Emergency department usage among parents	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Emergency department usage among siblings	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Ambulatory care usage among parents	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Ambulatory care usage among siblings	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Hospitalizations among parents	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Hospitalizations among siblings	Outcome will be assessed based on encounter data in de-identified claims data	3 years
Secondary	Adherence to chronic disease management standards among parents	Outcome will be assessed based on data in de-identified claims data	3 years
Secondary	Receipt of well-child visit and childhood immunizations among siblings	Outcome will be assessed based on data in de-identified claims data	3 years