Postoperative Delirium
Conditions
Keywords
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Mental Disorders, Cardiac Surgery, Mirrors
Brief summary
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.
Detailed description
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.
Interventions
OTHERMirrors Intervention
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.
Sponsors
Papworth Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled for elective or urgent cardiac surgery at Papworth Hospital * aged 70+ years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium incidence | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | This is the patient's first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU. |
| Mental Status | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) | Measured from Features 1 & 3 of CAM-ICU |
| Attention | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) | Measured from Feature 2 of CAM-ICU |
| Functional Independence | Assessed at 12 weeks after surgery | Measured using Barthel Index |
| Perceptual disturbances about the body and dissociative symptoms | Assessed at 12 weeks after surgery | Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011) |
| Delirium duration | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) | This is the total number of ICU days with delirium, as measured using the CAM-ICU |
| Length of ICU and hospital stay | Assessed at hospital hospital discharge | This is the patient's length of stay in ICU and hospital, in number of days from admission date until discharge date. |
| Mortality | Assessed at 12 weeks after surgery | This is patient mortality from admission to ICU until 12 weeks after surgery. |
| Factual memories from ICU | Assessed at 12 weeks after surgery | Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000) |
| 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) | This is a measure of the within-cluster correlation necessary for calculating sample size necessary for a definitive trial if warranted |
| 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) | 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. |
| Health-Related Quality of Life (HRQoL) | Assessed at 12 weeks after surgery | Measured using EQ-5D |
Countries
United Kingdom
Outcome results
None listed