Access and Transport to Paediatric Intensive Care Clinical Trial
— DEPICTOfficial title:
Critically Ill Children and Young People: do National Differences in
| NCT number | NCT03520192 |
| Other study ID # | 15HC47 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | December 31, 2021 |
| Verified date | October 2022 |
| Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2838 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 16 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Great Ormond Street Hospital for Children NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Great Ormond Street Hospital for Children NHS Foundation Trust |
United Kingdom,
Evans REC, Barber V, Seaton S, Draper ES, Rajah F, Pagel C, Polke E, Ramnarayan P, Wray J; DEPICT Study Investigators. Development of a parent experience measure for paediatric critical care transport teams. Nurs Crit Care. 2022 May;27(3):367-374. doi: 10 — View Citation
Evans REC, Barber V, Seaton S, Ramnarayan P, Davies P, Wray J; DEPICT Study Group. Is Parental Presence in the Ambulance Associated With Parental Satisfaction During Emergency Pediatric Intensive Care Retrieval? A Cross-Sectional Questionnaire Study. Pedi — View Citation
Ramnarayan P, Evans R, Draper ES, Seaton SE, Wray J, Morris S, Pagel C; DEPICT Study Investigators. Differences in access to Emergency Paediatric Intensive Care and care during Transport (DEPICT): study protocol for a mixed methods study. BMJ Open. 2019 Jul 16;9(7):e028000. doi: 10.1136/bmjopen-2018-028000. — View Citation
Seaton SE, Draper ES, Pagel C, Rajah F, Wray J, Ramnarayan P; DEPICT Study Team. The effect of care provided by paediatric critical care transport teams on mortality of children transported to paediatric intensive care units in England and Wales: a retros — View Citation
Seaton SE, Ramnarayan P, Davies P, Hudson E, Morris S, Pagel C, Rajah F, Wray J, Draper ES; DEPICT Study Team. Does time taken by paediatric critical care transport teams to reach the bedside of critically ill children affect survival? A retrospective coh — View Citation
Seaton SE, Ramnarayan P, Pagel C, Davies P, Draper ES; DEPICT Study Team. Impact on 30-day survival of time taken by a critical care transport team to reach the bedside of critically ill children. Intensive Care Med. 2020 Oct;46(10):1953-1955. doi: 10.100 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality | Number | 30 days | |
| Secondary | Mortality | Number | up to 90 days | |
| Secondary | Mortality | Number | 90 days | |
| Secondary | Mortality | Number | One year | |
| Secondary | Length of stay | Number (days) | up to 90 days | |
| Secondary | Days on invasive ventilation | Number (days) | up to 90 days | |
| Secondary | Vasoactive agent therapy | Number (days) | up to 90 days | |
| Secondary | Renal replacement therapy | Number (days) | up to 90 days | |
| Secondary | Extra-corporeal life support | Number (days) | up to 90 days | |
| Secondary | Length of hospital stay | Number (days) | up to 90 days | |
| Secondary | Number of hospital admissions | Number | One year | |
| Secondary | Days in hospital | Number (days) | One year |