Can Bedside Mirrors Reduce Delirium

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01599689
First received: May 8, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Postoperative Delirium
Other: Bedside Mirrors Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Can Bedside Mirrors Reduce Delirium in the Older Cardiac Surgical Patient? A Pilot Cluster Randomised Trial

Resource links provided by NLM:


Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Delirium incidence [ Time Frame: From day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).


Secondary Outcome Measures:
  • Delirium time of onset [ Time Frame: From day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    This is the patient's first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU.

  • Delirium duration [ Time Frame: From day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    This is the total number of ICU days with delirium, as measured using the CAM-ICU

  • Mental Status [ Time Frame: From day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    Measured from Features 1 & 3 of CAM-ICU

  • Attention [ Time Frame: From day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    Measured from Feature 2 of CAM-ICU

  • Functional Independence [ Time Frame: At ICU discharge, at post-discharge follow-up (6-12 weeks after surgery) ] [ Designated as safety issue: No ]
    Measured using Barthel Index

  • Perceptual disturbances about the body and dissociative symptoms [ Time Frame: At ICU discharge, at post-discharge follow-up (6-12 weeks after surgery) ] [ Designated as safety issue: No ]
    Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)

  • Health-Related Quality of Life (HRQoL) [ Time Frame: At post-discharge follow-up (6-12 weeks after surgery) ] [ Designated as safety issue: No ]
    Measured using EQ-5D

  • Length of ICU and hospital stay [ Time Frame: Assessed at discharge from ICU and at discharge from hospital (or at 12 weeks after surgery, whichever comes first) ] [ Designated as safety issue: No ]
    This is the patient's length of stay in ICU and hospital, in number of days from admission date until discharge date.

  • Mortality [ Time Frame: Assessed at 12 weeks after surgery ] [ Designated as safety issue: No ]
    This is patient mortality from admission to ICU until 12 weeks after surgery.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bedside Mirrors
Patients allocated to Bedside 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: Bedside 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.

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, 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, 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599689

Locations
United Kingdom
Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Principal Investigator: Dr. Alain Vuylsteke, MD Papworth Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01599689     History of Changes
Other Study ID Numbers: P01629, SA16/0212
Study First Received: May 8, 2012
Last Updated: June 27, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Papworth Hospital NHS Foundation Trust:
Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Cardiac Surgery
Mirrors

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014