- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675503
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- any one determined to be in need of walking aid and
- Can stand up from a seated position independently without assistance
- Can use ambulatory aid at home without assistance/supervision
- Can sit up in bed AND rise to a standing position independently
Exclusion Criteria:
- Not able to give consent
- Not able to use ambulatory aid independently
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No change in the standard of care.
|
|
|
Experimental: Fall Prevention Decision Support
Nursing assesses patient using the "Assistive Device Checklist" and provides assistive devices to patients, if appropriate. Decision support aimed at preventing hospital falls and empowering nurses. |
Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number Falls
Time Frame: Baseline and Six months after study
|
Participants's self reported number of falls will be assess at baseline and 6 months after trial.
|
Baseline and Six months after study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary S Ellen Lindros, Albert Einstein College of Medicine/Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013-2984
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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