NCT03675503

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

September 7, 2018

Last Update Submit

May 8, 2023

Conditions

Keywords

Fall PreventionHospital Acquired ConditionsNurse EducationAssistive Devices

Outcome Measures

Primary Outcomes (1)

  • Change in Number Falls

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

    Baseline and Six months after study

Study Arms (2)

Control

NO INTERVENTION

No change in the standard of care.

Fall Prevention Decision Support

EXPERIMENTAL

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

Interventions

Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls

Fall Prevention Decision Support

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not able to give consent
  • Not able to use ambulatory aid independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

Location

MeSH Terms

Conditions

Harm ReductionIatrogenic Disease

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary S Ellen Lindros

    Albert Einstein College of Medicine Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 18, 2018

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations