Prophylactic Environmental Management of Delirium

Not Applicable

Completed

• Conditions: Delirium; Falls
• Interventions: Other: Standard Care; Other: Environmental Intervention

• Registration Number: NCT01356810
• Lead Sponsor: Universidad de Valparaiso

Brief Summary

Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.

Detailed Description

A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Above 65 years of age and one of the following:
• Age above 70 years.
• Alcoholism
• Cognitive deficit (Mini mental state examination <24 points)
• Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)

Exclusion Criteria

• Delirium at admission.
• Admittance to a ward other than general internal medicine.
• Lack of family support.
• Informed consent refusal.
• Hospitalization in a room with more than two beds.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Delirium management defined by the attending physician.
Environmental Intervention	Environmental Intervention	-

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium	Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)	New episodes of delirium during the hospital stay

Secondary Outcome Measures

Name	Time	Method
Incidence of Falls	Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days	New episodes of Falls

Trial Locations

Locations (1)

Hospital Naval Almirante Nef; 🇨🇱 Vina del Mar, Valparaiso, Chile