Physiotherapy and Optimised Enteral Nutrition In the Post-acute Phase of Critical Illness (PHOENIX): A Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Intervention adherence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Study outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years) that received ≥ 4 days advanced respiratory support (defined as invasive or non-invasive ventilation) on ICU,
- •Alive at ICU discharge
- •On-going physiotherapy and dietetic rehabilitation needs identified by the PICUPS tool (Defined as patients who are unable to transfer from bed to chair independently AND not able to meet nutritional requirements independently).
排除标准
- •Death expected within the next 72 hours,
- •Poor pre-ICU admission mobility (inability to walk > 10 metres with or without an aid)
- •mobilisation contraindicated (e.g., spinal injury),
- •Contraindication to or inability to tolerate enteral nutrition,
- •Significant brain injury and not recovered to a GCS of ≥ 14 by ICU discharge.
结局指标
主要结局
Intervention adherence
时间窗: For 14 days following recruitment
Percentage of intervention sessions completed
Recruitment rate
时间窗: At recruitment within the 6 month screening window
Proportion of patients agreeing to take part out of all those invited (recruitment rate)
Retention rate
时间窗: from recruitment up to 30 days
Proportion of participants who complete the primary outcome (retention rate)
次要结局
- Days alive and out of hospital in 30 days(30 days following recruitment)
- Functional independence(At baseline, 14 days and 30 days)
- Health Related Quality of Life(At 30 days following recruitment)
- Physical Function(At baseline, 14 days and 30 days)