Does Mobilisation in the Evening Reduce the Incidence of Delirium in Patients Admitted to Intensive Care: a Mixed-methods, Randomised Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Recruitment rate
研究概览
简要总结
Patients with severe illness require lifesaving treatment in intensive care units. Around a third of patients admitted to intensive care develop delirium. This is a severe state of confusion. Delirium can be a frightening experience. Patients suffering from delirium can find it difficult to think clearly or understand what is happening. In some cases delirium can cause people to see or hear things that are not really there. Patients who develop delirium tend to spend longer in hospital and have worse overall outcomes. A major cause for the development of delirium is poor sleep. Previous research suggests that delirium levels can be reduced when patients are more active. The investigators have noticed that when patients in intensive care have physiotherapy during the day, they are often very tired and fall asleep quickly afterwards. The investigators think that patients who have physiotherapy in the evening will sleep better overnight and hope this will subsequently reduce the number who develop delirium.
To answer this question the investigators need to compare patients who are active in the evening with those who only have physiotherapy sessions during the day. Before a full study can take place it is important to make sure it is designed in the best way. To do this, 60 patients will be recruited from 2 hospitals in the UK over 6 months. Half of those who agree to take part will be seen by the physiotherapist in the evening, the other half will not. The investigators will then ask the following questions before deciding whether to do a full study
- Will patients agree to be a part of this trial?
- Will they agree to the additional physiotherapy sessions offered in the evening?
- Will patients and staff members be happy for us to randomly select who receives this extra treatment?
详细描述
The investigators hypothesise that mobilisation in the evening will promote more natural sleep, with patients becoming tired from physical exertion and plan to evaluate the impact this may have on reducing the incidence or duration of delirium.
A mixed-methods, two centre, randomised controlled feasibility study to establish the viability of conducting a larger multicentre RCT to test the effects of evening mobilisation on the incidence of ICU-acquired delirium.
Part 1 will evaluate whether it is possible to achieve acceptable recruitment and retention rates, intervention fidelity, and if the proposed data collection methods are appropriate.
Part 2 includes an acceptability analysis and qualitative evaluation, aiming to explore both patient and staff subjective experiences of the study intervention and proposed research methods (including willingness for randomisation and study outcome measures) and provide information to refine the study intervention (if required). The investigators will use principles of Normalisation Process Theory [28] and the NoMAD assessment tool [29] to assess the practicalities associated with implementing additional evening physiotherapy.
Treatment / Intervention The intervention will be delivered by a dedicated mobilisation team recruited from the study centres and will include trained ICU physiotherapists. Mobilisation will be delivered according to standardised procedures and established safety criteria. The intervention will begin on day 1 of admission or the first evening following recruitment.
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
All outcomes will be collected by an independent researcher 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)
- •Admitted to ICU,
- •Able to respond to verbal stimulus (Richmond Agitation Sedation Scale ≥ -3)
- •Expected to stay in the ICU for at least 24 hours.
排除标准
- •Death expected within the next 72 hours,
- •Immobility prior to admission,
- •Mobilisation contraindicated (e.g., spinal injury),
- •Delirium diagnosis during this ICU admission,
- •Acute or subacute severe neurological deficit or injury;
- •Severe psychiatric illness (not including depression) or developmental problems;
- •Suspected or confirmed drug or alcohol intoxication/overdose or withdrawal.
结局指标
主要结局
Recruitment rate
时间窗: 3 month recruitment window
Proportion of patients agreeing to take part out of all those invited
Intervention fidelity
时间窗: Up to 7 days following recruitment
Percentage of intervention sessions completed
Retention rate
时间窗: Up to 7 days following recruitment
Proportion of participants who complete the intervention
次要结局
- Sleep quality(During critical care stay, average of 2 weeks)
- Incidence of delirium(During critical care stay, average of 2 weeks)
- Duration of delirium(During critical care stay, average of 2 weeks)
- Mobility level at critical care discharge(At ICU discharge, average of 2 weeks)