Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Feasibility

NCT04909762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-02

No results posted yet for this study

Summary

19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). The investgators 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 National Institute of Health research/Health Technology Assessment funded programme with four stages:

1. The investgators undertook a national survey of perceptions, a systematic review of the literature and an observational study of ERM over 2 weeks across 14 United Kingdom PICUs
2. The investgators 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 the investgators 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, the investgatorswill 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, the investgators 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. the investgators 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.

Conditions

  • ICU
  • Critical Illness

Interventions

OTHER

Early Rehabilitation and Mobilisation (ERM)

Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package. It is provided by health professionals from multiple disciplines and care-givers within intensive care settings.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    collaborator OTHER
  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER
  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER
  • University of Birmingham

    lead OTHER

Principal Investigators

  • Barnaby Scholefield, Dr · Birmingham Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-11-30
Completion
2022-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909762 on ClinicalTrials.gov