Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids

May 8, 2023 updated by: Montefiore Medical Center

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

Terminated

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

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mary S Ellen Lindros, Albert Einstein College of Medicine/Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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