Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
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ClinicalTrials.gov Identifier: NCT03675503 |
Recruitment Status :
Terminated
(Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.)
First Posted : September 18, 2018
Last Update Posted : August 28, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Accidental Falls Harm Reduction | Other: Fall Prevention Decision Support | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
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No Intervention: Control
No change in the standard of care.
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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. |
Other: Fall Prevention Decision Support
Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls |
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675503
United States, New York | |
Montefiore Medical Center | |
New York, New York, United States, 10467 |
Principal Investigator: | Mary S Ellen Lindros | Albert Einstein College of Medicine/Montefiore Medical Center |
Responsible Party: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03675503 |
Other Study ID Numbers: |
2013-2984 |
First Posted: | September 18, 2018 Key Record Dates |
Last Update Posted: | August 28, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fall Prevention Hospital Acquired Conditions Nurse Education Assistive Devices |