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

NCT01599689 | Completed

• 2 other identifiers: P01629SA16/0212
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Delirium time of onset

  Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)

• Delirium duration

  Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)

• Mental Status

  Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)

• Attention

  Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first)

• Functional Independence

  Assessed at 12 weeks after surgery

Study Arms (2)

Mirrors Intervention

EXPERIMENTAL

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.

Other: Mirrors Intervention

Standard Care

NO INTERVENTION

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

Interventions

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.

Mirrors Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• scheduled for elective or urgent cardiac surgery at Papworth Hospital
• aged 70+ years

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 19300071 BACKGROUND

• 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.

  PMID: 18202215 BACKGROUND

• 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.

  PMID: 9265610 BACKGROUND

• 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.

  PMID: 10376620 BACKGROUND

• 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.

  PMID: 25493277 BACKGROUND

• 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.

  PMID: 27733826 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Delirium; Neurocognitive Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Mental Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Alain Vuylsteke, MD

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 16, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 22, 2015

Record last verified: 2013-06

Locations

GB (1)