Proximity Alarms to Reduce Patient Falls

Aging Clinical Trial

Official title:

Trial of Proximity Alarms to Reduce Patient Falls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183053
• Other study ID #: AG0050
• Secondary ID: R01AG025285
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 29, 2009
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: October 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• BedEx Patient Occupancy Monitoring System

Locations

Country	Name	City	State
United States	Methodist-University Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient falls over 15 months
Secondary	Restraint use
Secondary	patient care costs over 15 months