NCT00183053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

September 13, 2005

Last Update Submit

October 29, 2009

Conditions

Aging

Keywords

HospitalizationFall RiskFrailty

Outcome Measures

Primary Outcomes (1)

  • Patient falls over 15 months

Secondary Outcomes (2)

  • Restraint use

  • patient care costs over 15 months

Interventions

BedEx Patient Occupancy Monitoring SystemDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist-University Hospital

Memphis, Tennessee, 38104, United States

Location

Related Publications (6)

  • 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.

    PMID: 8121429BACKGROUND

  • 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.

    PMID: 12360147BACKGROUND

  • 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.

    PMID: 7625418BACKGROUND

  • 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.

    PMID: 2928815BACKGROUND

  • 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.

    PMID: 9366729BACKGROUND

  • 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.

    PMID: 23165660DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald I. Shorr, MD, MS

    Department of Aging & Geriatric Research, University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(1)