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Impact of Serious Pediatric Illness on Parent and Sibling Health

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ClinicalTrials.gov Identifier: NCT03971344
Recruitment Status : Enrolling by invitation
First Posted : June 3, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Cigna Foundation
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 396000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Serious Pediatric Illness on Parent and Sibling Health
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. New mental health diagnoses among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on diagnoses in de-identified claims data

  2. New mental health diagnoses among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on diagnoses in de-identified claims data

  3. New physical health diagnoses among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on diagnoses in de-identified claims data

  4. New physical health diagnoses among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on diagnoses in de-identified claims data

  5. New mental health prescriptions among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on prescription data in de-identified claims data

  6. New mental health prescriptions among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on prescription data in de-identified claims data

  7. New physical health prescriptions among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on prescription data in de-identified claims data

  8. New physical health prescriptions among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on prescription data in de-identified claims data


Secondary Outcome Measures :
  1. Emergency department usage among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  2. Emergency department usage among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  3. Ambulatory care usage among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  4. Ambulatory care usage among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  5. Hospitalizations among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  6. Hospitalizations among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data

  7. Adherence to chronic disease management standards among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on data in de-identified claims data

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See Eligibility Criteria
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971344


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Cigna Foundation
Investigators
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Principal Investigator: Chris Feudtner, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03971344     History of Changes
Other Study ID Numbers: FP00024612
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities