Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-03 @ 9:06 AM
Study NCT ID:
NCT03675503
Status:
TERMINATED
Last Update Posted:
2023-05-10
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial.
Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital.
Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.
Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital.
Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.
Detailed Description:
This research project proposes to study the effectiveness of a specific falls prevention intervention in a high risk population by providing ambulatory aids upon admission to the hospital to patients who previously used one at home after a standardized evaluation by a Registered Nurse. This will be a randomized controlled trial within three hospitals in a large academic medical center.
Primary Objectives:
Specific Aim 1: Evaluate the effectiveness in preventing falls by providing an ambulatory aid to patients who use an ambulatory aid at home, and who are deemed fit to use the device in the hospital by their nurse.
Specific Aim 2: Evaluate the nurses' ability to assess the appropriateness of providing an ambulatory aid, such as a cane or walker, to a patient who uses an assistive device at home.
Primary Objectives:
Specific Aim 1: Evaluate the effectiveness in preventing falls by providing an ambulatory aid to patients who use an ambulatory aid at home, and who are deemed fit to use the device in the hospital by their nurse.
Specific Aim 2: Evaluate the nurses' ability to assess the appropriateness of providing an ambulatory aid, such as a cane or walker, to a patient who uses an assistive device at home.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: