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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599689
• Other study ID #: P01629
• Secondary ID: SA16/0212
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: April 21, 2015
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Foundation Trust	Papworth Everard	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Vanhaudenhuyse A, Schnakers C, Brédart 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Functional Independence	Measured using Barthel Index	Assessed at 12 weeks after surgery
Secondary	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
Secondary	Health-Related Quality of Life (HRQoL)	Measured using EQ-5D	Assessed at 12 weeks after surgery
Secondary	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
Secondary	Mortality	This is patient mortality from admission to ICU until 12 weeks after surgery.	Assessed at 12 weeks after surgery
Secondary	Factual memories from ICU	Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000)	Assessed at 12 weeks after surgery
Secondary	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)
Secondary	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)