search
Back to results

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

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mirrors Intervention
Sponsored by
Papworth Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium focused on measuring Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Mental Disorders, Cardiac Surgery, Mirrors

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Papworth Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mirrors Intervention

Standard Care

Arm Description

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.

Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Delirium duration
This is the total number of ICU days with delirium, as measured using the CAM-ICU
Mental Status
Measured from Features 1 & 3 of CAM-ICU
Attention
Measured from Feature 2 of CAM-ICU
Functional Independence
Measured using Barthel Index
Perceptual disturbances about the body and dissociative symptoms
Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)
Health-Related Quality of Life (HRQoL)
Measured using EQ-5D
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.
Mortality
This is patient mortality from admission to ICU until 12 weeks after surgery.
Factual memories from ICU
Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)
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
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.

Full Information

First Posted
May 8, 2012
Last Updated
April 21, 2015
Sponsor
Papworth Hospital NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01599689
Brief Title
Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients
Official Title
Can an Evidence-based Mirrors Intervention Reduce Postoperative Delirium in Older Cardiac Surgical Patients? A Pilot and Feasibility Cluster Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Mental Disorders, Cardiac Surgery, Mirrors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirrors Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors.
Intervention Type
Other
Intervention Name(s)
Mirrors Intervention
Intervention Description
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 Outcome Measure Information:
Title
Delirium incidence
Description
Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU).
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Secondary Outcome Measure Information:
Title
Delirium time of onset
Description
This is the patient's first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU.
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Title
Delirium duration
Description
This is the total number of ICU days with delirium, as measured using the CAM-ICU
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Title
Mental Status
Description
Measured from Features 1 & 3 of CAM-ICU
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Title
Attention
Description
Measured from Feature 2 of CAM-ICU
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Title
Functional Independence
Description
Measured using Barthel Index
Time Frame
Assessed at 12 weeks after surgery
Title
Perceptual disturbances about the body and dissociative symptoms
Description
Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011)
Time Frame
Assessed at 12 weeks after surgery
Title
Health-Related Quality of Life (HRQoL)
Description
Measured using EQ-5D
Time Frame
Assessed at 12 weeks after surgery
Title
Length of ICU and hospital stay
Description
This is the patient's length of stay in ICU and hospital, in number of days from admission date until discharge date.
Time Frame
Assessed at hospital hospital discharge
Title
Mortality
Description
This is patient mortality from admission to ICU until 12 weeks after surgery.
Time Frame
Assessed at 12 weeks after surgery
Title
Factual memories from ICU
Description
Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)
Time Frame
Assessed at 12 weeks after surgery
Title
Intraclass correlation coefficient (ICC) for time clusters
Description
This is a measure of the within-cluster correlation necessary for calculating sample size necessary for a definitive trial if warranted
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Title
Acceptability of the intervention
Description
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.
Time Frame
Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Alain Vuylsteke, MD
Organizational Affiliation
Papworth Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papworth Hospital NHS Foundation Trust
City
Papworth Everard
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19300071
Citation
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.
Results Reference
background
PubMed Identifier
18202215
Citation
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.
Results Reference
background
PubMed Identifier
9265610
Citation
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.
Results Reference
background
PubMed Identifier
10376620
Citation
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.
Results Reference
background
PubMed Identifier
25493277
Citation
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.
Results Reference
background
PubMed Identifier
27733826
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs