Physiotherapy and Optimised Enteral Nutrition in the post-Acute phase of critical illness (PHOENIX): Protocol for a mixed methods feasibility randomised controlled trial

Introduction Each year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice. We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU. Methods and analysis Physiotherapy and Optimised Enteral Nutrition In the post-Acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial. Ethics and dissemination Ethical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media. Trial registration number NCT06159868. Prospectively registered on 28 November 2023.