Decision Making in Serious Pediatric Illness (DSPI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01163136
First received: July 13, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

This study will look at a cohort of parents whose children are confronting life-threatening illnesses in intensive care, palliative care, and complex care settings, to test whether parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to change the "level of care" order status of their child (as an important and demonstrable example of adapting goals); b) to reprioritize goals for the child when they are reassessed regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent' attributes.


Condition
Parental Decision Making for Seriously Ill Children

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decision Making in Serious Pediatric Illness

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Parents' reprioritized goals [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Parents, when interviewed every 4 months for up to 2 years, are asked what the goals of care are for their child, and if the priority of those goals has changed.


Secondary Outcome Measures:
  • Parents' self-defined 'good parent' attributes [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Parents, when interviewed every 4 months for up to 2 years, are asked how they assess their achievement of attributes of being a good parent to their ill child


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Parents making medical decisions for a child living with a life-threatening condition confront, sometimes repeatedly, an extremely daunting task: how to decide when to set aside the therapeutic goal of cure or of life prolongation and instead prioritize the goals of comfort or quality of life.

This study will look at a cohort of parents whose children are confronting life-threatening illnesses in intensive care, palliative care, and complex care settings, to test whether parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to change the "level of care" order status of their child (as an important and demonstrable example of adapting goals); b) to reprioritize goals for the child when they are reassessed regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent' attributes.

We hypothesize that parents with higher levels of hopeful patterns of thinking subsequently will be:

More likely to enact a limit of intervention order. More likely, upon explicit formal reassessment, to reprioritize goals for the child.

More likely to report a higher degree of achieving self-defined 'good parent' attributes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parents of children of age < 18 years or cognitively impaired such that their parents make all medical decisions on their behalf; and of either gender and any race/ethnicity who are patients at The Children's Hospital of Philadelphia (CHOP) admitted to the neonatal, pediatric, or cardiac intensive care unit (CICU), neonatal intensive care unit (NICU), or pediatric intensive care unit (PICU), or who have been referred to the Pediatric Advanced Care Team (PACT) for palliative care services.

Criteria

Inclusion Criteria:

  • Parents of children who are patients at The Children's Hospital of Philadelphia (CHOP) admitted to the neonatal, pediatric, or cardiac intensive care unit (NICU, PICU, or CICU), or who have been referred to the Pediatric Advanced Care Team (PACT) for palliative care services. A patient is eligible when the patient's attending physician considers it likely that parents will have major treatment decisions to make for their child within the coming 12 to 24 months.

Exclusion Criteria:

  • Non English-speaking parents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163136

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Chris Feudtner, MD, PhD, MPH Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01163136     History of Changes
Other Study ID Numbers: 10-007447, 1R01NR012026-01
Study First Received: July 13, 2010
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Parental decision making
Decision Making in Serious Pediatric Illness (DSPI)
palliative care decision making

ClinicalTrials.gov processed this record on April 17, 2014