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Trial record 3 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Differences in Access to Emergency Paediatric Intensive Care and Care During Transport (DEPICT)

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ClinicalTrials.gov Identifier: NCT03520192
Recruitment Status : Not yet recruiting
First Posted : May 9, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

There are fewer than 30 paediatric intensive care units (PICUs) in the United Kingdom (UK). This means that a critically ill child taken to their nearest hospital will need to be transferred to a PICU. Such transports are usually done by PICU retrieval teams (PICRTs), mobile teams who take specialist expertise to the child and safely transport them to a PICU.

There are national variations in how PICRTs are organised and deliver clinical care. There has been little research into these differences and how they might influence outcomes and experiences for sick children and families. The investigators do not know if national variation in how PICRT services are organised and delivered matters, or whether current standards help achieve the best outcomes for patients. This clinical study aims to understand how existing differences in access to paediatric intensive care and care provided by PICRTs affect clinical outcomes and experiences for transported critically ill children and families. The investigators will analyse routine national audit data to examine various aspects such as how long it takes a PICRT to reach the patient, how long it takes the child to reach the PICU, the seniority of clinicians performing the transport, medical procedures performed by the PICRT and any critical incidents during transport, and investigate whether any of these factors influence how likely a child is to survive. The investigators will also collect and analyse information about the experiences of sick children by interviewing the families involved, and staff experiences of PICU retrieval by interviewing clinicians. Alongside this work, the investigators will look at the costs of different ways of delivering PICRT services for sick children, and use mathematical techniques to study if and how alternate models of service delivery can improve clinical outcomes in a cost effective manner. The research team in this trial includes PICU and transport clinicians, parents, academic experts and an National Health Service (NHS) commissioner.

Independent committees consisting of clinicians and parents will be formed to oversee the study. The work from this study will directly inform the development of evidence-based national standards for PICU transport and help improve the patient experience for critically ill children and their families.


Condition or disease
Access and Transport to Paediatric Intensive Care

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Critically Ill Children and Young People: do National Differences in
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Number


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 90 days ]
    Number

  2. Mortality [ Time Frame: 90 days ]
    Number

  3. Mortality [ Time Frame: One year ]
    Number

  4. Length of stay [ Time Frame: up to 90 days ]
    Number (days)

  5. Days on invasive ventilation [ Time Frame: up to 90 days ]
    Number (days)

  6. Vasoactive agent therapy [ Time Frame: up to 90 days ]
    Number (days)

  7. Renal replacement therapy [ Time Frame: up to 90 days ]
    Number (days)

  8. Extra-corporeal life support [ Time Frame: up to 90 days ]
    Number (days)

  9. Length of hospital stay [ Time Frame: up to 90 days ]
    Number (days)

  10. Number of hospital admissions [ Time Frame: One year ]
    Number

  11. Days in hospital [ Time Frame: One year ]
    Number (days)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young people (age <16 years) transported by a PIC retrieval team for emergency admission to a paediatric intensive care unit in England and Wales.
Criteria

Inclusion Criteria:

  • Children and young people (age <16 years) transported by a PIC retrieval team for emergency admission to a paediatric intensive care unit in England and Wales.

Exclusion Criteria:

  • None

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): NCT03520192


Contacts
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Contact: Nick Hudson 0207 269 9277 nick.hudson@icnarc.org

Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03520192     History of Changes
Other Study ID Numbers: 15HC47
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Paediatric
Critical care
Transport