Paediatric Early Rehabilitation/Mobilisation During InTensive Care

NCT04110938 | Unknown DMC

• 1 other identifier: RG_18-161
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Although survival rates from PICU are at an all-time high (\>96%), low levels of mortality have been offset by an increase in morbidity. The impact of being critically ill and exposed to the PICU is multiple. Weakness, cognitive impairment, organ dysfunction, and psychological problems have been reported to emanate from deconditioning. Subsequently, post-PICU many CYP experience significant and residual physical, cognitive, and psychosocial morbidities that impact on their quality of life. The contemporary focus has turned to the development, testing, and implementation of interventions to minimize the harmful effects of critical care and maximize patient outcomes. Early rehabilitation and/or mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health professionals from multiple disciplines and care-givers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive). Rehabilitation has been shown to improve quality of life and patient outcomes; reduce health inequalities, and make significant savings to the health care system. Benefits have been demonstrated in the use of ERM in adult ICU populations in relation to patient outcomes as well as healthcare utilization. Studies also indicate that the intervention is safe and feasible, reduces delirium and increases ventilator-free days, improves day-to-day functioning and reduces hospital readmissions. However, in the United Kingdom (UK), the understanding of current ERM practices (including content, barriers, facilitators, feasibility, and safety) and their impact on the outcomes of pediatric ICU patients is limited. This has stifled an evidence-based approach to ERM which has resulted in disparity in the adoption and utilization of ERM interventions in PICUs across the UK. To address this critical gap, the first phase of a four-phase program of the PERMIT study will generate evidence of current PICU ERM practices by conducting a survey and an observational study. The second phase of the study will involve conducting qualitative workshops to develop a prototype ERM program. Qualitative workshops will also be conducted among key stakeholders (clinicians, parents, CYP) to inform the design of an ERM intervention. The third phase will investigate this ERM program in a pilot study in UK PICUs and finally, the efficacy of the intervention will be tested using a large scale, definitive randomized controlled trial (RCT).

Conditions

ICU; Critical Illness

Keywords

PICU; Paediatric; Early mobilisation; Early rehabilitation; Observational

Outcome Measures

Primary Outcomes (1)

• Number of early rehabilitation and/or mobilisation (ERM) delivered on Day 3 post PICU admission

  The prevalence and scope of ERM will be described as the proportion of patients with any 'active interaction' delivered on Day 3 post-admission.

  3 weeks

Secondary Outcomes (5)

• Incidence rates and ratios of the number of ERM interventions from Day 3 to Day 10 post PICU admission

  3 weeks

• The cumulative prevalence of ERM for each day in PICU after Day 3 up to Day 10 post-admission

  3 weeks

• Factors associated with variability of early rehabilitation and/or mobilisation (ERM) delivery

  3 weeks

• To evaluate predictors of ERM provided on Day 3 post-PICU-admission

  3 weeks

• Dose of ERM per day of PICU admission

  3 weeks

Eligibility Criteria

• Age: 38 Weeks - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All Children and Young Persons (CYP) (0-\<16 years) admitted to paediatric itnesive care units for 3 days or more

You may qualify if:

• All Children and Young Persons (CYP) (0-\<16 years)
• Admitted to PICU
• Remain within PICU on day 3 post-admission

You may not qualify if:

• Local decision by PI or treating clinical team not to include patient
• Parent or guardian choose to opt out.

Sponsors & Collaborators

• University of Birmingham: lead
• University of Nottingham: collaborator
• Newcastle University: collaborator
• Northumbria University: collaborator
• University of Cambridge: collaborator
• University of Leeds: collaborator
• Imperial College London: collaborator

Study Sites (1)

Birmingham Women's 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

07968722758; b.scholefield@bham.ac.uk

Jacqueline Thompson, MPH

CONTACT

012141459107; j.y.thompson@bham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: October 1, 2019
• Study Start: October 28, 2019
• Primary Completion: November 30, 2019
• Study Completion: October 31, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-08

Locations

GB (1)