Paediatric Early Rehabilitation and Mobilisation during InTensive care feasibility study: The PERMIT study

The PERMIT Study is a multi-phased, mixed-methods study with a number of objectives embedded within study phases. Phase one involves cross-sectional and observational studies conducted to understand current ERM practice within Paediatric Intensive Care Units (PICU).

During Phase one:

1. We will conduct a nationwide survey to identify and describe current Early Rehabilitation and Mobilisation (ERM) practice within UK PICU's.

2. We will also assess the capability of UK PICU's to deliver ERM by conducting an observational study. We would then establish and model how many infants, children and young people would be appropriate for ERM among the PICU population.

Recruitment to the PERMIT observational study will take place at 15 UK PICU's in England and Scotland. We plan to recruit a minimum of 150 paediatric patients into the study.

1. Addenbrookes Cambridge

2. Alder Hey Children's NHS Foundation Trust

3. Birmingham Children’s Hospital

4. Evelina London Children's Hospital

5. Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

6. GOSH CICU, Great Ormond Street Hospital for Children NHS Foundation Trust

7. GOSH PICU, Great Ormond Street Hospital for Children NHS Foundation Trust

8. Great North Children's Hospital, Newcastle

9. Nottingham Children’s Hospital

10. Oxford University Hospitals

11. Royal Hospital for Children Glasgow

12. Royal Manchester Children’s Hospital

13. Southampton Children’s Hospital, Southampton General Hospital

14. St Mary's Hospital, Imperial London

15. University Hospital Leicester and Glenfield Hospital, Leicester

We will include:

• All Infants, Children and Young Persons (CYP) (0-<16 years)

• Admitted to selected 14 PICU's across the country

• Who remain within PICU on Day 3 post-admission

Exclusion:

• Local decision by PI or treating clinical team not to include patient

• Parent or guardian choose to opt out.

The aim of this observational study is to understand current Early Rehabilitation and Mobilisation (ERM) practice within Paediatric Intensive Care (PIC) settings and establish barriers or facilitators to ERM delivery. We will observe and record data on current ERM processes within PICU’s but not intervene on patient care pathways. Data accrued by the PERMIT study will be supplemented with routine clinical collected by a national audit database - Paediatric Intensive Care Audit Network (PICANet).

Primary outcome

• The primary aim of the study is to ascertain the prevalence of Early Rehabilitation and Mobilisation (ERM) delivery on Day 3 post PICU admission. The primary outcome will provide a clearer picture of how frequently paediatric patient’s currently receive ERM when admitted within UK PICU’s

Secondary outcomes

• To estimate the Prevalence and Incidence of ERM delivery between Day 3 and Day 10 post PICU admission;

• To quantify the volume of ERM delivered per patient;

• To characterise the clinical features of patients receiving ERM;

• To describe the type of ERM interventions delivered in PICU’s and;

• To determine factors associated with variability of ERM delivery between PICU's. The secondary outcomes will provide an indication of what patients receive, which patients will benefit the most from ERM interventions and how best to measure improvement after receiving ERM management.

We will undertake a number of rounds of co-designed workshops with key stakeholders (clinicians, parents, Children and Young Persons (CYP)) to develop detailed Early Rehabilitation and Mobilisation (ERM) intervention prototypes and descriptions of feasible and acceptable ways in which they can be delivered to different patient groups and in different contexts. The workshops will be supplemented with qualitative interviews with CYP for whom the workshop format would not be optimally accessible.

Findings from; Phase One and Phase Two will inform the design of a prototype ERM intervention.

During Phase Three the prototype intervention will be piloted across 3 Paediatric Intensive Care Unit (PICU's) within the UK. The aim of the multicentre pilot study is to determine the acceptability and feasibility of the model intervention package and identify possible challenges to attaining recruitment targets during a large-scale multi-centre randomised controlled trial.

CI: Dr. Barney Scholefield

Co-investigator(s)

Trial Office Contact Details