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临床试验/NCT03971344
NCT03971344已完成不适用

Impact of Serious Pediatric Illness on Parent and Sibling Health

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 161,000 人开始时间: 2020年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161,000
试验地点
1
主要终点
New mental health diagnoses among parents

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

New mental health diagnoses among parents

时间窗: 3 years

Outcome will be assessed based on diagnoses in de-identified claims data

New mental health diagnoses among siblings

时间窗: 3 years

Outcome will be assessed based on diagnoses in de-identified claims data

New physical health diagnoses among parents

时间窗: 3 years

Outcome will be assessed based on diagnoses in de-identified claims data

New physical health diagnoses among siblings

时间窗: 3 years

Outcome will be assessed based on diagnoses in de-identified claims data

New mental health prescriptions among parents

时间窗: 3 years

Outcome will be assessed based on prescription data in de-identified claims data

New mental health prescriptions among siblings

时间窗: 3 years

Outcome will be assessed based on prescription data in de-identified claims data

New physical health prescriptions among parents

时间窗: 3 years

Outcome will be assessed based on prescription data in de-identified claims data

New physical health prescriptions among siblings

时间窗: 3 years

Outcome will be assessed based on prescription data in de-identified claims data

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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