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NCT Number: NCT01599689

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

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirrors Intervention

Other

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.

Primary outcomes

  1. Delirium incidence

    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 will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).

Secondary outcomes

  1. Delirium time of onset

    Time frame: 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.

  2. Delirium duration

    Time frame: 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

  3. Mental Status

    Time frame: 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

  4. Attention

    Time frame: 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

  5. Functional Independence

    Time frame: Assessed at 12 weeks after surgery

    Measured using Barthel Index

  6. Perceptual disturbances about the body and dissociative symptoms

    Time frame: Assessed at 12 weeks after surgery

    Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)

  7. Health-Related Quality of Life (HRQoL)

    Time frame: Assessed at 12 weeks after surgery

    Measured using EQ-5D

  8. Length of ICU and hospital stay

    Time frame: 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.

  9. Mortality

    Time frame: Assessed at 12 weeks after surgery

    This is patient mortality from admission to ICU until 12 weeks after surgery.

  10. Factual memories from ICU

    Time frame: Assessed at 12 weeks after surgery

    Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)

  11. Intraclass correlation coefficient (ICC) for time clusters

    Time frame: 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

  12. Acceptability of the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2012
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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