Proximity Alarms to Reduce Patient Falls

NCT ID: NCT00183053

Last Updated: 2009-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-10-31

Brief 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

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

BedEx Patient Occupancy Monitoring System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: lead

Principal Investigators

Ronald I. Shorr, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Aging & Geriatric Research, University of Florida

Locations

Methodist-University Hospital

Memphis, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8121429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12360147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7625418 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2928815 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9366729 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23165660 (View on PubMed)

Other Identifiers

R01AG025285

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0050

Identifier Type: -

Identifier Source: org_study_id