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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: Mirrors Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
      • Papworth Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Mirrors 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.
No Intervention: Standard Care; 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?

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)

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Dr. Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
• Freysteinson WM. The use of mirrors in critical care nursing. Crit Care Nurs Q. 2009 Apr-Jun;32(2):89-93. doi: 10.1097/CNQ.0b013e3181a27b3d.
• Vanhaudenhuyse A, Schnakers C, Bredart S, Laureys S. Assessment of visual pursuit in post-comatose states: use a mirror. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):223. doi: 10.1136/jnnp.2007.121624. No abstract available.
• Tabak N, Bergman R, Alpert R. The mirror as a therapeutic tool for patients with dementia. Int J Nurs Pract. 1996 Sep;2(3):155-9. doi: 10.1111/j.1440-172x.1996.tb00042.x.
• Tung ML, Murphy IC, Griffin SC, Alphonso AL, Hussey-Anderson L, Hughes KE, Weeks SR, Merritt V, Yetto JM, Pasquina PF, Tsao JW. Observation of limb movements reduces phantom limb pain in bilateral amputees. Ann Clin Transl Neurol. 2014 Sep;1(9):633-8. doi: 10.1002/acn3.89. Epub 2014 Sep 30.
• Giraud K, Pontin M, Sharples LD, Fletcher P, Dalgleish T, Eden A, Jenkins DP, Vuylsteke A. Use of a Structured Mirrors Intervention Does Not Reduce Delirium Incidence But May Improve Factual Memory Encoding in Cardiac Surgical ICU Patients Aged Over 70 Years: A Pilot Time-Cluster Randomized Controlled Trial. Front Aging Neurosci. 2016 Sep 28;8:228. doi: 10.3389/fnagi.2016.00228. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Cardiac Surgery; Confusion; Neurologic Manifestations; Mental Disorders; Delirium; Signs and Symptoms; Delirium, Dementia, Amnestic, Cognitive Disorders; Neurobehavioral Manifestations; Mirrors
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: P01629; SA16/0212 (Other Grant/Funding Number: The Dunhill Medical Trust)