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Proximity Alarms to Reduce Patient Falls
This study has been completed.
Study NCT00183053   Information provided by National Institute on Aging (NIA)
First Received: September 13, 2005   Last Updated: October 29, 2009   History of Changes

September 13, 2005
October 29, 2009
May 2006
October 2007   (final data collection date for primary outcome measure)
Patient falls over 15 months
Same as current
Complete list of historical versions of study NCT00183053 on ClinicalTrials.gov Archive Site
  • Restraint use
  • patient care costs over 15 months
Same as current
 
Proximity Alarms to Reduce Patient Falls
Trial of Proximity Alarms to Reduce Patient Falls

The purpose of this study is to test an intervention to introduce and implement proximity alarms on the risk of falls in hospitalized patients.

Proximity alarm systems are promoted as an approach to reduce falls and decrease use of physical restraints in hospitals, but they have not been tested rigorously. This study will implement proximity alarms at Methodist-University Hospital (M-UH), a 652-bed urban community hospital in Memphis, Tennessee. The hospital provides primary to tertiary care to a diverse adult patient population. The group randomized trial will be conducted on 16 25-bed general medical-surgical nursing units at M-UH. Nursing units will be randomized within blocks of 2 based on rates of falls that occur during an initial 3-month observation period. Over a 15-month intervention, 8 nursing units will be randomized to receive the alarm-based intervention, and 8 will utilize existing nursing care methods to minimize falls. Intervention units will receive an adequate supply of proximity alarm monitoring systems to apply to all patients considered by nursing staff to be at high risk for falls. An implementation team, consisting of a nurse-champion, geriatrician and biomedical instrumentation specialist, will train and conduct regular follow-up on intervention units to address technical issues related to use of the alarms. The primary outcome measure, patient falls, will be ascertained prospectively by a nurse-manager using a method developed to collect patient (e.g., orientation and postural blood pressure) and environmental data collected in a standardized manner. The primary aim of the study is to determine whether proximity alarm monitoring reduces falls. The study has been designed to test the hypothesis that patient falls will be 25% lower on intervention units compared to control units. The secondary aims are to determine whether proximity alarm monitoring reduces the use of physical restraints, or decreases patient care costs. This will be the first methodologically sound study to evaluate this promising approach to reducing falls in hospitals. Whether or not alarms successfully reduce falls, findings from this study have the potential to widely impact purchasing decisions and clinical practice related to fall prevention in acute-care settings.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Aging
Device: BedEx Patient Occupancy Monitoring System
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10000
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient admitted to one of 16 study units at Methodist University Hospital
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183053
 
AG0050, R01AG025285
National Institute on Aging (NIA)
 
Principal Investigator: Ronald I. Shorr, MD, MS Department of Aging & Geriatric Research, University of Florida
National Institute on Aging (NIA)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP