Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06159868 |
Other study ID # |
DM633323 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
May 1, 2025 |
Study information
Verified date |
June 2024 |
Source |
University Hospitals Coventry and Warwickshire NHS Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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, 140,000 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 1:1 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.