Parental Decision Making for Seriously Ill ChildrenDSPINCT01163136
Decision Making in Serious Pediatric Illness
An observational study of Parental Decision Making for Seriously Ill Children, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parental Decision Making for Seriously Ill Children
- How many people
- 358 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non English-speaking parents
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Keywords
- Parental decision making, Decision Making in Serious Pediatric Illness (DSPI), palliative care decision making
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' reprioritized goals
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.
Measured: up to 2 years
Secondary outcomes (1)
Parents' self-defined 'good parent' attributes
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2014
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Decision Making for Seriously Ill ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Chris Feudtner, MD, PhD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163136
- Sponsor's protocol ID
- 10-007447
- Other IDs
- 1R01NR012026-01
- Acronym
- DSPI
- Status last verified
- Sep 2017
- First submitted
- 13 Jul 2010
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Serious Pediatric Illness
- ClinicalTrials.gov ID
- NCT01163136
- Acronym / sponsor ID
- DSPI / 10-007447
- Keywords
- Parental decision making, Decision Making in Serious Pediatric Illness (DSPI), palliative care decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non English-speaking parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parents' reprioritized goals
Time frame: up to 2 years
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.
1 secondary outcome
Parents' self-defined 'good parent' attributes
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Feudtner, MD, PhD, MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Decision Making for Seriously Ill Children, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' reprioritized goals (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.