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NCT ID: NCT04909762 Not yet recruiting - Critical Illness Clinical Trials

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

PERMIT
Start date: June 2021
Phase: N/A
Study type: Interventional

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 implementationÍž 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.

NCT ID: NCT04110938 Not yet recruiting - Critical Illness Clinical Trials

Paediatric Early Rehabilitation/Mobilisation During InTensive Care

PERMIT
Start date: October 28, 2019
Phase:
Study type: Observational [Patient Registry]

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).