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出境医 / 临床实验 / Impact of Serious Pediatric Illness on Parent and Sibling Health

Impact of Serious Pediatric Illness on Parent and Sibling Health

Study Description
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.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 161000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Serious Pediatric Illness on Parent and Sibling Health
Actual Study Start Date : January 30, 2020
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020
Arms 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.
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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:

-

Contacts and Locations

Locations
Layout table for location information
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Cigna Foundation
Investigators
Layout table for investigator information
Principal Investigator: Chris Feudtner, MD Children's Hospital of Philadelphia
Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 2019
Last Update Posted Date August 31, 2020
Actual Study Start Date January 30, 2020
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2019)
  • Emergency department usage among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Emergency department usage among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Ambulatory care usage among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Ambulatory care usage among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Hospitalizations among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Hospitalizations among siblings [ Time Frame: 3 years ]
    Outcome will be assessed based on encounter data in de-identified claims data
  • Adherence to chronic disease management standards among parents [ Time Frame: 3 years ]
    Outcome will be assessed based on data in de-identified claims data
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Serious Pediatric Illness on Parent and Sibling Health
Official Title Impact of Serious Pediatric Illness on Parent and Sibling Health
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population See Eligibility Criteria
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 27, 2020) 		161000
Original Estimated Enrollment
 (submitted: May 30, 2019) 		396000
Actual Study Completion Date July 31, 2020
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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:

-
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971344
Other Study ID Numbers FP00024612
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor Children's Hospital of Philadelphia
Collaborators Cigna Foundation
Investigators
Principal Investigator: Chris Feudtner, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date August 2020

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