Can an Evidence-based Mirrors Intervention Reduce Postoperative Delirium in Older Cardiac Surgical Patients? A Pilot and Feasibility Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Delirium incidence
研究概览
简要总结
This pilot cluster-randomised controlled trial aims to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.
详细描述
The risk of delirium, an acute disturbance in mental status and cognition that occurs commonly after cardiac surgery, increases sharply from the age of about 65 years. Its occurrence, even for one day, is associated with longer ICU and hospital stays, increased costs, and negative physical and cognitive outcomes at one year. In spite of previous prevention and intervention research, delirium incidence in the older cardiac surgical patient remains high (up to 72%).
ICU clinicians at Papworth Hospital have made observations suggesting that delirium could be reduced using a novel and unconventional strategy of bedside mirrors. Mirrors of any type are uncommon in ICU environments[1], but their occasional use by patients on our ICU has been reported by bedside clinicians and physiotherapists to result in:
- a normalisation of mental status and attention (core delirium diagnostic criteria), and
- earlier physical mobilisation (associated with reduced delirium risk), particularly in older-aged patients
Evidence from other sources supports mirrors' beneficial effect in these areas [2-10], but mirror use has never to our knowledge been explored for the reduction of delirium. This pilot study seeks to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for elective or urgent cardiac surgery at Papworth Hospital
- •aged 70+ years
排除标准
- •inability to obtain informed consent
- •care pathway anticipating admission elsewhere than to ICU following surgery
- •severe visual impairment impeding ability to recognise self in mirror
- •physical or communication barriers likely to impede effective administration of study procedures
- •severe mental disability likely to impede effective administration of study procedures or assessment of delirium
- •history of psychiatric illness previously requiring hospitalisation
研究组 & 干预措施
Mirrors Intervention
Patients allocated to Mirrors will receive a structured, protocol-driven bedside mirrors intervention as part of their postsurgical ICU care. This intervention will commence as soon as all anaesthetic agents have been switched off and the patient is awake following surgery unless considered clinically inappropriate.
干预措施: Mirrors Intervention (Other)
Standard Care
Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors.
结局指标
主要结局
Delirium incidence
时间窗: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).
次要结局
- Delirium duration(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))
- Mental Status(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))
- Attention(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))
- Functional Independence(Assessed at 12 weeks after surgery)
- Delirium time of onset(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))
- Factual memories from ICU(Assessed at 12 weeks after surgery)
- Perceptual disturbances about the body and dissociative symptoms(Assessed at 12 weeks after surgery)
- Health-Related Quality of Life (HRQoL)(Assessed at 12 weeks after surgery)
- Length of ICU and hospital stay(Assessed at hospital hospital discharge)
- Mortality(Assessed at 12 weeks after surgery)
- Intraclass correlation coefficient (ICC) for time clusters(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))
- Acceptability of the intervention(Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first))