Title: The PERMIT study. Paediatric Early Rehabilitation/Mobilisation during InTensive care feasibility study.
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Critical illness or injury affects 20,000 children and young people (CYP) annually in the UK. Whilst 96% survive, many experience significant physical, cognitive, and psychosocial morbidities, impacting their quality of life. Evidence from paediatric and adult critical care suggests that early rehabilitation/mobilisation (ERM) is safe, and may improve patient outcomes and care costs. However, ERM is not established in UK Paediatric Intensive Care (PICs), and evidence of its impact is required prior to wider-scale implementation. AIMS: To prepare for a definitive ERM trial, we will: i) identify current ERM practice, ii) specify the content of an ERM intervention; ii) establish the patient population for whom ERM may be appropriate; iii) determine patient-centred outcomes of ERM, and appropriate measures; iv) explore the feasibility and acceptability of an ERM future trial. DESIGN/TIMETABLE: Four-phase mixed-methods feasibility study over 24 months, drawing on best practice guidance on developing/evaluating complex rehabilitation interventions. Phase 1 (months 1- 6): identify current ERM practice and establish patient populations (survey of clinical leads, point prevalence study in PICs, rapid review of broad ERM literature). Phase 2 (months 7-16): develop ERM interventions and manualise. Define patient-centred outcomes. (co-design workshops, rapid review of ERM outcomes literature, survey of UK stakeholders). Phase 3 (months 17-21): Test ERM and outcome tool feasibility in PICs (design and test in two independent PICs). Phase 4 (months 22-24): synthesise data, consensus building workshop, report findings, and develop a clinical trial protocol with Birmingham Clinical Trials Unit. SETTING: UK NHS PICs POPULATION: Target population for ERM to be established during PERMIT. CYP, families, medical, nursing and allied health staff will be subjects of wide feasibility assessment and consultation. COSTS/OUTCOME MEASUREMENT: Feasibility criteria for definitive RCT. Patient-centred outcomes/measures (including economic data) for ERM to be determined in Phase 2&3. HEALTH TECHNOLOGY: ERM encompasses techniques to promote physical (movement, mobility, function) and non-physical (cognitive, speech, psychological) recovery. ERM is tailored to individual CYP and typically delivered in discrete or bundled packages by multidisciplinary clinicians and parents. STUDY OUTPUTS: Fully specified, feasible and acceptable ERM manual, including outcome measurement protocol and differentiation from standard rehabilitation interventions (usual care); protocol for ERM clinical trial. TEAM EXPERTISE: We have established a multidisciplinary team of clinicians, clinical academics, methodologists, and service users, led by an NIHR-funded clinician scientist and supported by a fully registered clinical trials unit. Our combined expertise includes paediatric critical care, nursing, allied health (occupational, physical, and speech and language therapy), psychological and play interventions, epidemiology, systematic reviewing, qualitative research, complex intervention development/evaluation, health economics, clinical trials, statistics, and first-hand service user experience. We have extensive experience of NIHR HTA project delivery, and are supported by international ERM experts and a wide range of UK stakeholder groups (see letters).

Lay abstract: Each year 20,000 children and young people (CYP) become so ill or badly injured that they need to be admitted to a Paediatric Intensive Care Unit (PICU). Thankfully over 95% of them survive and are discharged but they can have a number of problems for many weeks and months afterwards. Problems can include physical issues with weakness, having difficulty eating or finding it harder to concentrate than before. Also, both they and their family members may feel more anxious as a result of their experiences. Some patients will therefore need extra support, known as ‘rehabilitation’ to help them recover. There is some research with adult intensive care patients which shows that the earlier this rehabilitation is provided, the quicker they recover, but less is known about rehabilitation with CYP in this situation. We want to see if patients recover quicker if they are given rehabilitation early on and encouraged to get moving while they are still in PICU. This is known as ‘early rehabilitation and mobilisation’ (ERM). Our research team includes doctors, nurses, therapists and researchers who have experience of working in PICU. We will also talk regularly to former patients and their families to make sure we consider their views. Study aims: 1) find out how much ERM is currently being offered to CYP in UK PICUs and what form this support takes; 2) learn what families and staff think are the most important aspects to help recovery; 3) put together guidelines to deliver ERM. We will then try out these guidelines in 2 PICUs to see if they are useful 4) make suggestions about further research How will this be done? There are 4 phases to the study. Phase 1: we will collect information on 150 patients admitted to 14 PICUs in the same three-week period. Health professionals from all 27 PICUs in the UK will be asked about the ERM measures their unit can offer, how much is offered and who provides the ERM activities. We will also study published research for details of what works best for CYP as they recover from critical illness. In this way we will put together a clear picture of what is currently known and what is currently happening with ERM. Phase 2: We will interview a number of patients, family members and staff (nurses, doctors, physios, occupational therapists, dieticians, psychologists, play specialists) about their experiences of ERM. In this way we hope to learn more about what is difficult, what is helpful and what further research is needed. With the information from phase 1 and 2 we will put together a set of guidelines on what seems to be the best way to offer this early support. Phase 3: In phase 3 we will try out the set of guidelines in 3 different PICUs and find out from patients, families and staff whether they find them useful. Phase 4: In the final phase of the project the research team will meet up with the families and health professionals who have been involved in phases 1-3 and pull together their recommendations. What will we do with the results? We will report on the results of this research to health professionals at conferences, through professional groups and by publishing our findings in health journals. The results will also be fed back to the families who took part and the wider public through social media. Finally, we will write a report for the NIHR, who have provided the funding for the work and make recommendations on how future research should be carried out.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE