Prophylactic Environmental Management of Delirium (MAPDI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Manejo Ambiental Profilactico Del Delirium Intrahospitalario|
- Incidence of Delirium [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days) ] [ Designated as safety issue: No ]New episodes of delirium during the hospital stay
- Incidence of Falls [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days ] [ Designated as safety issue: No ]New episodes of Falls
|Study Start Date:||September 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Standard Care
Delirium management defined by the attending physician.
Other: Standard Care
Delirium management by the attending physician's preferences.
|Experimental: Environmental Intervention||
Other: Environmental Intervention
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356810
|Hospital Naval Almirante Nef|
|Vina del Mar, Valparaiso, Chile|
|Principal Investigator:||Felipe T Martinez, MD||Universidad de Valparaiso|