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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
223
Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care. To be administered at set times and in a standardised way by ICU nursing and physical therapy teams.
Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridgeshire, United Kingdom
Delirium incidence
Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Delirium time of onset
This is the patient's first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU.
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Delirium duration
This is the total number of ICU days with delirium, as measured using the CAM-ICU
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Mental Status
Measured from Features 1 \& 3 of CAM-ICU
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Attention
Measured from Feature 2 of CAM-ICU
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Functional Independence
Measured using Barthel Index
Time frame: Assessed at 12 weeks after surgery
Perceptual disturbances about the body and dissociative symptoms
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Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)
Time frame: Assessed at 12 weeks after surgery
Health-Related Quality of Life (HRQoL)
Measured using EQ-5D
Time frame: Assessed at 12 weeks after surgery
Length of ICU and hospital stay
This is the patient's length of stay in ICU and hospital, in number of days from admission date until discharge date.
Time frame: Assessed at hospital hospital discharge
Mortality
This is patient mortality from admission to ICU until 12 weeks after surgery.
Time frame: Assessed at 12 weeks after surgery
Factual memories from ICU
Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)
Time frame: Assessed at 12 weeks after surgery
Intraclass correlation coefficient (ICC) for time clusters
This is a measure of the within-cluster correlation necessary for calculating sample size necessary for a definitive trial if warranted
Time frame: 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
This is the number of instances when the intervention was considered appropriate by clinicians and accepted and used by patients, divided by total recorded indicated instances.
Time frame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)