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

NCT04909762 | Unknown DMC

• 1 other identifier: ERN_18-1134
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The investgators worked with professionals and families to develop an ERM manual appropriate for the age and acuity level of the child.
3. 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. 4.Make suggestions about further research.

Conditions

ICU; Critical Illness

Keywords

PICU; Paediatric; Early mobilisation; Early rehabilitation; Observational

Outcome Measures

Primary Outcomes (3)

• Number of PICUs implementing PERMIT intervention

  The prevalence and scope of ERM will be described as the proportion of PICUs progressing from step 1 (PICU preparation) to step 2 (patient delivery). Assessment of implementation progress within PICUs (e.g. barriers and facilitators to implementation) PICUs using the weekly debrief with PERMIT champions, the three brief online surveys of PICU health care professionals and the interviews with PICU health care professionals.

  4 weeks

• Proportion of eligible CYP recruited to receive the PERMIT intervention

  The proportion of eligible CYP recruited to receive the PEMRIT intervention will be calculated as the number of eligible CYP recruited divided by the total number of eligible CYP at each site.

  4 weeks

• Proportion of completed outcome assessment tools of eligible CYP

  Proportion of CYP with 100% completed outcome measurement tools and \>50% completed will be recorded at each PICU site.

  4 weeks

Secondary Outcomes (3)

• Acceptability of all data collection forms, outcome measurement tools and the PERMIT intervention as a whole

  4 weeks

• Number of ERM activities prescribed per CYP following patient acuity screening

  4 weeks

• Number of ERM activities delivered per CYP

  4 weeks

Study Arms (1)

Early rehabilitation and mobilisation

OTHER

Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health care professionals from multiple disciplines and parents/carers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive). In adult intensive care, ERM has been shown in clinical trials to improve long term physical functioning and return to independence. It can also shorten the length of ventilation and stay in intensive care and hospital with significant economic benefit.

Other: Early Rehabilitation and Mobilisation (ERM)

Interventions

Early Rehabilitation and Mobilisation (ERM) OTHER

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.

Early rehabilitation and mobilisation

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Steps 1-3:
• The PERMIT champions: health care professionals (HCP) and managers from each PICU who will lead the implementation of the PERMIT intervention. The PERMIT champions could be the PI, the PIC manager, a consultant lead, a physio lead and a senior nurse but this is decided locally.
• HCP: Health care professionals who work within the PICU and could be /are involved in delivering the PERMIT intervention to CYP (i.e. doctors, nurses, allied health professionals, play therapists, psychologists etc.).
• Steps 2-3:
• CYP
• Admitted to a participating PICU. Age 0 to \<16 years at time of admission. Likely to remain within PICU on day 3 post admission. Consent by parent/legal guardian.
• Step 3:
• Parents/legal guardians of CYP fulfilling criteria above.

You may not qualify if:

• Steps 1-3:
• PERMIT champions who decline to participate in the debrief.
• Steps 2-3:
• Local decision by PICU health care professionals not to include CYP.

Sponsors & Collaborators

• University of Birmingham: lead
• King's College Hospital NHS Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Birmingham Women's and Children's NHS Foundation Trust: collaborator

Study Sites (1)

Birmingham Women and Children's Hospital PICU

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Related Publications (1)

• Scholefield BR, Menzies JC, McAnuff J, Thompson JY, Manning JC, Feltbower RG, Geary M, Lockley S, Morris KP, Moore D, Pathan N, Kirkham F, Forsyth R, Rapley T. Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study. Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.

  PMID: 38063184 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barnaby Scholefield, Dr

  Birmingham Women's and Children's Hospital

  STUDY CHAIR

Central Study Contacts

Barnaby Scholefield, Dr

CONTACT

00441213339684; b.scholefield@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will receive Early Rehabilitation and Mobilisation intervention.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: June 2, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-03

Locations

GB (1)