Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Feasibility
NCT04909762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-06-02
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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