Clinical Trial: Proximity Alarms to Reduce Patient Falls

This study is not yet open for patient recruitment.
Verified by National Institute on Aging (NIA) September 2005

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00183053

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Trial of Proximity Alarms to Reduce Patient Falls

Further Study Details: 
Primary Outcomes: Patient falls over 15 months
Secondary Outcomes: Restraint use; patient care costs over 15 months
Expected Total Enrollment:  10000

Study start: May 2006;  Expected completion: March 2008
Last follow-up: August 2007;  Data entry closure: December 2007

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
Criteria

Inclusion Criteria:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00183053

Ronald I. Shorr, MD, MS      901-448-5900    rshorr@utmem.edu

Tennessee
      Methodist-University Hospital, Memphis,  Tennessee,  38104,  United States
Ronald I. Shorr, MD, MS,  Principal Investigator

Study chairs or principal investigators

Ronald I. Shorr, MD, MS,  Principal Investigator,  University of Tennessee Health Science Center and Methodist-University Hospital   

More Information

Publications

Tideiksaar R, Feiner CF, Maby J. Falls prevention: the efficacy of a bed alarm system in an acute-care setting. Mt Sinai J Med. 1993 Nov;60(6):522-7.

Morse JM. Enhancing the safety of hospitalization by reducing patient falls. Am J Infect Control. 2002 Oct;30(6):376-80.

Bates DW, Pruess K, Souney P, Platt R. Serious falls in hospitalized patients: correlates and resource utilization. Am J Med. 1995 Aug;99(2):137-43.

Morse JM, Black C, Oberle K, Donahue P. A prospective study to identify the fall-prone patient. Soc Sci Med. 1989;28(1):81-6.

Oliver D, Britton M, Seed P, Martin FC, Hopper AH. Development and evaluation of evidence based risk assessment tool (STRATIFY) to predict which elderly inpatients will fall: case-control and cohort studies. BMJ. 1997 Oct 25;315(7115):1049-53.

Study ID Numbers:  AG0050; R01AG025285
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00183053
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27

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