Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can an Evidence-based Mirrors Intervention Reduce Postoperative Delirium in Older Cardiac Surgical Patients? A Pilot and Feasibility Cluster Randomised Controlled Trial

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Other: Mirrors Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirrors Intervention<br>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. | Other: Mirrors Intervention<br>* 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.<br>|
| No Intervention: Standard Care<br>Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence | Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU). | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | Assessed at 12 weeks after surgery | 
| Perceptual disturbances about the body and dissociative symptoms | Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011) | Assessed at 12 weeks after surgery | 
| Health-Related Quality of Life (HRQoL) | Measured using EQ-5D | 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. | Assessed at hospital hospital discharge | 
| Mortality | This is patient mortality from admission to ICU until 12 weeks after surgery. | Assessed at 12 weeks after surgery | 
| Factual memories from ICU | Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000) | 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 | 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. | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Mental Disorders, Cardiac Surgery, Mirrors