PERMIT phase 3 feasibility study

• Research type

  Research Study

• Full title

  The PERMIT Intervention feasiblity study Feasibilty of implementating the Paediatric Early Rehabilitation/Mobilisation during InTensive care (PERMIT) Intervention

• IRAS ID

  287244

• Contact name

  Barnaby Scholefield

• Contact email

  b.scholefield@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Clinicaltrials.gov Identifier

  NCT04110938

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). We want to see if patients recover quicker if rehabilitation starts early and they are encouraged to get moving whilst still in PICU. This is known as ‘early rehabilitation and mobilisation’ (ERM).
  PERMIT is an NIHR/HTA funded programme with four stages:
  1) We undertook a national survey of perceptions, a systematic review of the literature and an observational study of ERM over 2 weeks across 14 UK PICUs
  2) We worked with professionals and families to develop an ERM manual appropriate for the age and acuity level of the child.
  3) In the current phase we will try out the ERM manual in 3 PICUs to see if they are useful and then
  4) Make suggestions about further research.
  This protocol outlines the third stage, exploring feasibility and acceptability of implementing the PERMIT intervention in the following Steps:
  Step 1: Implementing the PERMIT intervention within 3 PICUs
  Step 2: Enrolling and delivering PERMIT intervention to CYP in PICU
  Step 3: Measuring outcomes and assessing impact of PERMIT intervention on CYP and parents.
  Over 5 months, we will share the ERM manual with 6-15 key staff on 3 PICUs so that they can consider implementation; they will be interviewed weekly. 90 staff will be eligible to complete 3 online questionnaires. If implementation is feasible, we will recruit up 30 children aged 0-16 years in 3 PICUs if parents consent. On ward rounds the PICU team will use the ERM manual to assess acuity and prescribe ERM. We will collect routine data and observe whether prescribed ERM is delivered. After further consent, up to 30 parents can complete questionnaires at PICU discharge and interviews (n=12-15 consenting, approx 3 declining Step 2) within 30 days. 12-15 staff will be interviewed.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  21/SC/0127

• Date of REC Opinion

  26 Apr 2021

• REC opinion

  Favourable Opinion