Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03675503
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 128

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Number Falls [Baseline and Six months after study]

   Participants's self reported number of falls will be assess at baseline and 6 months after trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	New York	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03675503
• Other Study ID Numbers: 2013-2984
• First Posted: Sep 18, 2018
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• 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

Study Results

No Results Posted as of Aug 28, 2019