Clinical trial NCT01599689: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2012-05-16
Enrollment: 223
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Delirium incidence
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Secondary outcomes:
measure: Delirium time of onset
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
measure: Delirium duration
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
measure: Mental Status
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
measure: Attention
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
measure: Functional Independence
timeFrame: Assessed at 12 weeks after surgery
measure: Perceptual disturbances about the body and dissociative symptoms
timeFrame: Assessed at 12 weeks after surgery
measure: Health-Related Quality of Life (HRQoL)
timeFrame: Assessed at 12 weeks after surgery
measure: Length of ICU and hospital stay
timeFrame: Assessed at hospital hospital discharge
measure: Mortality
timeFrame: Assessed at 12 weeks after surgery
measure: Factual memories from ICU
timeFrame: Assessed at 12 weeks after surgery
measure: Intraclass correlation coefficient (ICC) for time clusters
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
measure: Acceptability of the intervention
timeFrame: Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Dr. Alain Vuylsteke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.