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

Funded by National Institute for Health Research

 

 

Every year in the UK up to 20,000 infants, children and young people require treatment following a critical illness or injury within a Paediatric Intensive Care Unit (PICU). Almost all (96%) survive; however, some survivors require long durations of ICU care, experience long term health problems and slow recovery.

Early rehabilitation and mobilisation (ERM) is a broad term for a range of physical activities, therapies and modification to standard critical care treatments that can be delivered to patients during their stay in the intensive care units (ICU). In adult ICUs, ERM has reduced the amount of physical weakness, reduced the overall length of time patients are in ICU and promoted faster recovery to normal activities when home. However, there remains a lack of evidence and guidance for the use of ERM for infants, children and young people within paediatric ICUs.

The PERMIT Study, funded by the NIHR Health Technology Assessment programme, aims to understand how ERM could be used within Paediatric ICUs in the UK, what should be included within an ERM programme, which patients could potentially benefit and how a clinical trial to establish its impact could be designed.

The PERMIT Study team is led by Dr Barney Scholefield, NIHR Clinician Scientist and Consultant in Paediatric Intensive Care at University of Birmingham and Birmingham Women & Children’s Hospital. The team comprises a large, nationwide, multidisciplinary team of academics, clinicians and parent representatives from PICU, neurology, rehabilitation medicine, physiotherapists, occupational therapists and clinical trial researchers from UK Universities and the NHS.

The research programme is split into three main phases. These will investigate in:

  • Phase 1: The current use of ERM within UK PICU's using surveys and a multi-centre observational study;

  • Phase 2: Establishing which ERM interventions and clinical outcomes should be examined in the future, using co-designed workshops and interviews with health care professionals, children and their families;

  • Phase 3: Testing the feasibility of running a clinical trial by piloting the preferred ERM intervention package.

Phase One

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.

Setting

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

Study population

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.

Intervention

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).

Outcomes

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.

Phase Two

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.

Other research group staff members

CI: Dr. Barney Scholefield

Co-investigator(s)

Rob Forsyth
Consultant Neurologist
Institute of Health and Society
Newcastle University

Tim Rapley
Professor
Northumbria University

Jenniffer McAnuff
Academic Occupational Therapist
Institute of Health and Society, Newcastle University

Nazima Pathan
Consultant in Paediatric Intensive Care
Department of Paediatrics, The Chancellor, Masters and Scholars of the University of Cambridge

Stephen Brett
Consultant in Intensive Care
Department of Surgery and Cancer
Imperial College of Science, Technology and Medicine

Joseph Manning
NIHR /HEE Clinical Lecturer
Charge Nurse Paediatric Critical Care Outreach
The University of Nottingham and Nottingham University Hospitals NHS Trust

David Moore
Senior Lecturer
Institute of Applied Health
University of Birmingham

Michelle Geary
Physiotherapist
Child Health, University Hospital Southampton
NHS Foundation Trust

Fenella Kirkham
Professor of Neurology
Child Health, University Hospital Southampton
NHS Foundation Trust

Gillian Colville
Psychologist
Paediatric Psychology Service
St George's University Hospitals, NHS Foundation Trust

Julie Menzies
Senior PICU Research Nurse
Paediatric Intensive Care
Birmingham Children's Hospital NHS
Foundation Trust

Kevin Morris
Honorary Professor of Paediatric Intensive Care
Paediatric Intensive Care
Birmingham Children's Hospital NHS Foundation Trust

Roger Parslow
Senior Lecturer
University of Leeds Child Health

Dr Richard Feltbower
Principal Investigator PICANet
PICANet, University of Leeds Child Health

Hannah Child
Advisor
Birmingham Children's Hospital

Sophie Lockley
PPI Representative

Trial Office Contact Details

Faaria Hussain
Project Manager for PERMIT study
Institute of Microbiology and Infection
Biosciences Building
College of Medical and Dental Sciences
University of Birmingham
Edgbaston Birmingham
B15 2TT
f.hussain@bham.ac.uk

Jacqueline Y. Thompson
Research Fellow for PERMIT study
Public Health Building
Institute of Applied Health Research
University of Birmingham
Birmingham
B15 2TT
j.y.thompson@bham.ac.uk