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Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

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.


Condition or disease Intervention/treatment Phase
Accidental Falls Harm Reduction Other: Fall Prevention Decision Support Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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.

Other: Fall Prevention Decision Support
Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Mary S Ellen Lindros Albert Einstein College of Medicine/Montefiore Medical Center
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montefiore Medical Center:
Fall Prevention
Hospital Acquired Conditions
Nurse Education
Assistive Devices