Proximity Alarms to Reduce Patient Falls
October 29, 2009 updated by: National Institute on Aging (NIA)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38104
- Methodist-University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient admitted to one of 16 study units at Methodist University Hospital
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Patient falls over 15 months
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Secondary Outcome Measures
Outcome Measure |
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Restraint use
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patient care costs over 15 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ronald I. Shorr, MD, MS, Department of Aging & Geriatric Research, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1067/mic.2002.125808.
- 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. doi: 10.1016/s0002-9343(99)80133-8.
- 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. doi: 10.1016/0277-9536(89)90309-2.
- 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. doi: 10.1136/bmj.315.7115.1049.
- Shorr RI, Chandler AM, Mion LC, Waters TM, Liu M, Daniels MJ, Kessler LA, Miller ST. Effects of an intervention to increase bed alarm use to prevent falls in hospitalized patients: a cluster randomized trial. Ann Intern Med. 2012 Nov 20;157(10):692-9. doi: 10.7326/0003-4819-157-10-201211200-00005.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
November 1, 2009
Last Update Submitted That Met QC Criteria
October 29, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AG0050
- R01AG025285 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.