Proximity Alarms to Reduce Patient Falls

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00183053
First received: September 13, 2005
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention
Aging
Device: BedEx Patient Occupancy Monitoring System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Proximity Alarms to Reduce Patient Falls

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Patient falls over 15 months

Secondary Outcome Measures:
  • Restraint use
  • patient care costs over 15 months

Estimated Enrollment: 10000
Study Start Date: May 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted to one of 16 study units at Methodist University Hospital
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183053

Locations
United States, Tennessee
Methodist-University Hospital
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald I. Shorr, MD, MS Department of Aging & Geriatric Research, University of Florida
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00183053     History of Changes
Other Study ID Numbers: AG0050, R01AG025285
Study First Received: September 13, 2005
Last Updated: October 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Hospitalization
Fall Risk
Frailty

ClinicalTrials.gov processed this record on April 22, 2014