Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183053
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-09-13
Brief Title:
Proximity Alarms to Reduce Patient Falls
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Trial of Proximity Alarms to Reduce Patient Falls
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG025285 | NIH | None | httpsreporternihgovquickSearchR01AG025285 |