Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159868
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-28
Brief Title:
Physiotherapy and Optimised Nutrition in Survivors of Critical Illness
Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Organization:
University Hospitals Coventry and Warwickshire NHS Trust
Study Overview
Official Title:
Physiotherapy and Optimised Enteral Nutrition In the Post-acute Phase of Critical Illness PHOENIX A Randomised Controlled Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHOENIX
Brief Summary:
The goal of this randomised controlled feasibility study is to assess the feasibility and acceptability of individualised physiotherapy and optimised nutrition delivered on the ward following discharge from intensive care to increase days alive and out of hospital as well as the proposed methodology to optimise design and delivery for a definitive evaluation trial Specific objectives are
i To assess acceptability of the intervention to users and providers ii To assess feasibility of recruitment procedures for a future trial iii To estimate recruitment retention and measure completion rates for a future trial
Participants will receive a combination of structured individualised physiotherapy and optimised nutrition beginning immediately following recruitment and continuing for up to 14days or hospital discharge whichever is sooner As a feasibility trial the primary outcomes to be assessed are around study feasibility The investigators will also compare clinical outcomes for the intervention participants in comparison to those receiving standard care to see if the intervention increases the number of days alive and out of hospital within 30 days of recruitment
i To assess acceptability of the intervention to users and providers ii To assess feasibility of recruitment procedures for a future trial iii To estimate recruitment retention and measure completion rates for a future trial
Participants will receive a combination of structured individualised physiotherapy and optimised nutrition beginning immediately following recruitment and continuing for up to 14days or hospital discharge whichever is sooner As a feasibility trial the primary outcomes to be assessed are around study feasibility The investigators will also compare clinical outcomes for the intervention participants in comparison to those receiving standard care to see if the intervention increases the number of days alive and out of hospital within 30 days of recruitment
Detailed Description:
Research question Is it feasible and acceptable to undertake a randomised controlled trial evaluating the clinical and cost-effectiveness of an individualised physiotherapy and nutrition support intervention delivered on the ward following ICU discharge in adult survivors of critical illness
Background Each year in the UK 140000 patients are discharged from intensive care units ICU to general hospital wards almost all with complex rehabilitation needs Eighty-four percent 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 in itself and additionally acts 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 combining adequate nutrition and exercise on the general ward has driven widespread variation in practice
The investigators 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
Aims To evaluate the feasibility and acceptability of conducting a randomised controlled trial evaluating the clinical and cost-effectiveness of structured individualised physiotherapy and nutritional support in ward-based patients following ICU discharge
Objectives
i To assess acceptability of the intervention to users and providers ii To assess feasibility of recruitment procedures for a future trial iii To estimate recruitment retention and measure completion rates
Methods PHOENIX is a two-centre allocation-concealed open-label parallel group randomised controlled feasibility trial with integrated qualitative evaluation of acceptability
The investigators will recruit sixty adult survivors from intensive care units at two university hospitals with ongoing physiotherapy and nutritional needs at ICU discharge Participants will be randomised on a 11 basis to receive the structured rehabilitation intervention or standard care The intervention comprises enhanced physiotherapy delivered by a specialist critical care team in combination with optimised nutrition guided by indirect calorimetry
Primary feasibility outcomes are recruitment and retention rates and intervention fidelity Acceptability will be evaluated through semi structured interviews of participants and staff
Background Each year in the UK 140000 patients are discharged from intensive care units ICU to general hospital wards almost all with complex rehabilitation needs Eighty-four percent 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 in itself and additionally acts 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 combining adequate nutrition and exercise on the general ward has driven widespread variation in practice
The investigators 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
Aims To evaluate the feasibility and acceptability of conducting a randomised controlled trial evaluating the clinical and cost-effectiveness of structured individualised physiotherapy and nutritional support in ward-based patients following ICU discharge
Objectives
i To assess acceptability of the intervention to users and providers ii To assess feasibility of recruitment procedures for a future trial iii To estimate recruitment retention and measure completion rates
Methods PHOENIX is a two-centre allocation-concealed open-label parallel group randomised controlled feasibility trial with integrated qualitative evaluation of acceptability
The investigators will recruit sixty adult survivors from intensive care units at two university hospitals with ongoing physiotherapy and nutritional needs at ICU discharge Participants will be randomised on a 11 basis to receive the structured rehabilitation intervention or standard care The intervention comprises enhanced physiotherapy delivered by a specialist critical care team in combination with optimised nutrition guided by indirect calorimetry
Primary feasibility outcomes are recruitment and retention rates and intervention fidelity Acceptability will be evaluated through semi structured interviews of participants and staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None