Prophylactic Environmental Management of Delirium

Study Overview
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Brief Summary
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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
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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.

Official Title
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Manejo Ambiental Profilactico Del Delirium Intrahospitalario

Conditions
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Delirium, Falls

Intervention / Treatment
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* Other: Environmental Intervention
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Care<br>Delirium management defined by the attending physician. | Other: Standard Care<br>* Delirium management by the attending physician's preferences.<br>|
| Experimental: Environmental Intervention<br> | Other: Environmental Intervention<br>* The environmental intervention consisted of daily reorientation, avoidance of sensorial deprivation, longer visiting hours, the availability of a clock, a calendar and the presence of familiar objects in the room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Delirium | New episodes of delirium during the hospital stay | Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Falls | New episodes of Falls | Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Primary Prevention, Elderly