Clinical Trials Directory

Trials / Completed

CompletedNCT00183053

Proximity Alarms to Reduce Patient Falls

Trial of Proximity Alarms to Reduce Patient Falls

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10,000 (estimated)
Sponsor
National Institute on Aging (NIA) · NIH
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEBedEx Patient Occupancy Monitoring System

Timeline

Start date
2006-05-01
Primary completion
2007-10-01
Completion
2007-10-01
First posted
2005-09-16
Last updated
2009-11-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00183053. Inclusion in this directory is not an endorsement.