Environmental Intervention on Delirious Patients

The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium

The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Behavioral: environmental intervention

Detailed Description

Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.

Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hakjae Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• with an age of 18 years or older
• who understood the purpose of this study and agreed to participate
• stayed in the SICU for a period of 48 hours or longer

Exclusion Criteria:

• who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
• who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
• who had a history of severe psychiatric or neurologic deficit
• who required an isolation room due to transplantation or immunologic compromise
• who were discharged from ICU within 48 hours
• who were re-admitted to the ICU
• who were less than 18 years old
• who were admitted to the Surgical ICU through another ICU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: pre-intervention; Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment)
Experimental: post-intervention; After providing environmental intervention for critically ill patients	Behavioral: environmental intervention; provide environmental intervention (help sleep cycle, provide comfortable environment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence rate of delirium	5 month
time to delirium onset	5 month
the duration of delirium	5 month

Secondary Outcome Measures

Outcome Measure	Time Frame
the number of days of ventilator use	5 month
the length of stay at the SICU	5 month
the length of stay at hospital	5 month
the rate of re-admission to the SICU	5 month
mortality rate.	5 month

Collaborators and Investigators

• Sponsor: Asan Medical Center

Publications and helpful links

General Publications

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
• Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
• Holt R, Young J, Heseltine D. Effectiveness of a multi-component intervention to reduce delirium incidence in elderly care wards. Age Ageing. 2013 Nov;42(6):721-7. doi: 10.1093/ageing/aft120. Epub 2013 Aug 26.
• Arenson BG, MacDonald LA, Grocott HP, Hiebert BM, Arora RC. Effect of intensive care unit environment on in-hospital delirium after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jul;146(1):172-8. doi: 10.1016/j.jtcvs.2012.12.042. Epub 2013 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): October 31, 2014

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; critically ill patients; environmental intervention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: AsanMC-Delirium

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No