TY - JOUR
T1 - Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness (PHOENIX): protocol for a mixed methods feasibility randomised controlled trial
AU - McWilliams, David
AU - Owen, Gustafson
AU - Wyer, Nicola
AU - Couper, Keith
AU - Kimani, Peter
AU - Kandiyali, Rebecca
AU - Barghouthy, Dalia
AU - Haylett, Rebekah
AU - Richardson, Holly
AU - Negus-Fancey, Miles
AU - King, Elizabeth
AU - Gallie, L
AU - Puthucheary, Zudin
PY - 2025/3/27
Y1 - 2025/3/27
N2 - 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. 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. 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. NCT06159868. Prospectively registered on 28 November 2023. [Abstract copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.]
AB - 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. 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. 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. NCT06159868. Prospectively registered on 28 November 2023. [Abstract copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.]
KW - Critical Illness
KW - Enteral Nutrition
KW - Exercise
KW - Feasibility Studies
KW - Humans
KW - Intensive Care Units
KW - Intensive care units
KW - Malnutrition
KW - Multicenter Studies as Topic
KW - Nutrition & Dietetics
KW - Physical Therapy Modalities
KW - Randomized Controlled Trials as Topic
KW - Rehabilitation Medicine
KW - United Kingdom
KW - REHABILITATION MEDICINE
KW - NUTRITION & DIETETICS
UR - https://doi.org/10.1136/bmjopen-2025-100803
UR - http://www.scopus.com/inward/record.url?scp=105001360323&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2025-100803
DO - 10.1136/bmjopen-2025-100803
M3 - Article
SN - 2044-6055
VL - 15
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e100803
ER -