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Proximity Alarms to Reduce Patient Falls

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Aging

Treatments

Device: BedEx Patient Occupancy Monitoring System

Study type

Interventional

Funder types

NIH

Identifiers

NCT00183053
AG0050
R01AG025285 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patient admitted to one of 16 study units at Methodist University Hospital

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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