Geriatric Emergency Department Fall Injury Prevention Project (GREAT-FALL)

February 21, 2025 updated by: Florida Atlantic University
This prospective randomized study will assess an emergency department (ED) based prevention strategy in geriatric patients at high risk for recurrent falls and injury. Falling is a major health hazard in older adults with a number of proposed but unproven protocols to prevent fall-related injuries. This study proposes to study one of these strategies, the CDC's Stopping Elderly Accidents, Deaths and Injuries program (the STEADI Program).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess whether certain Emergency Department patients at high risk of recurrent falls and injuries related to falls will benefit from the recommendations of the Center for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths and Injuries program (STEADI Program).

Study subjects will be randomized to one of 3 arms: 1) current care; 2) a phone-based fall-prevention strategy; or 3) a home-visit fall prevention strategy

  1. Current emergency department care
  2. STEADI recommendations administered via phone at 14 days
  3. STEADI recommendations administered via a home visit at 14 days

The STEADI recommendations include the following:

  • Follow-up with a primary care physician
  • An assessment of your risk of falling. This includes looking at your ability to walk, your strength and balance.
  • Assessment medications looking for potential medication interactions
  • Measuring your vital signs (blood pressure and heart rate)
  • Assessment of your vision
  • Assessment of your footwear
  • Recommendations to improve home safety (such as ensuring proper lighting, ensuring adequate hand-rails, and others)

Initial data collection will occur at the time of the ED visit. Intervention will occur 14 days after ED visit. Telephonic follow-up will occur at 3 months and 6 months after study enrollment.

Data will be collected from the patients/patient representatives and medical records. All data will be collected by trained research assistants (RAs)

Study Type

Interventional

Enrollment (Actual)

644

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

  • United States
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray 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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over the age of 65 with a ground level fall who live at home will be eligible for study inclusion

Exclusion Criteria:

  • Being transferred from another facility, trauma activation, hospice or palliative care participant, end-stage heart failure (two or more congestive heart failure hospitalizations in past 6 months), end stage emphysema (two or more chronic obstructive pulmonary disease hospitalizations in past 6 months), metastatic cancer, severe leukemia or multiple myeloma or lymphoma on treatment or requiring transfusion and end stage renal disease requiring dialysis. An additional exclusion criterion is patients with dementia, if the subject is unable to state name or unable to point to an object (for those with aphasia)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Current care
Current care at the ED
Experimental: Phone-based fall-prevention strategy

The phone-based fall-prevention strategy is based on the CDC's Stopping Elderly Accidents Deaths & Injuries (STEADI) program (https://www.cdc.gov/steadi/index.html). The STEADI Algorithm will be the template for both fall-prevention strategies utilized in this study. In addition, the CDC Check For Safety-A Home Prevention Checklist for Older Adults pamphlet will be used.

At the time of study enrollment, the STEADI program written material will be provided and components of it will be discussed with the study subjects and caregivers, if present.

The phone-based strategy will provide the patient and caregiver easy to read materials before ED discharge and a structured phone call around 14 days post ED discharge.
Other: Phone-based fall-prevention strategy
Written education material and Phone-Based Fall-Prevention Strategy
Experimental: Home-visit fall prevention strategy
The specific components of the home-visit fall prevention strategy are similar to the Phone-Based Fall-Prevention Strategy. The essential difference is the in-person visit by the research associate to discuss and reinforce the fall-prevention strategy.
Other: Home-visit fall prevention strategy
Written education material and Home visit-Based Fall-Prevention Strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent fall requiring ED revisit at 6 months
Time Frame: 6 months
Number of Participants with 6 months ED Returns
6 months
Fall-related injury at 6 months
Time Frame: 6 months
Number of Participants with 6 months ED Returns
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific fall-related injury at 6 months
Time Frame: 6 months
Number of Participants with 6 months ED Returns
6 months
Fall-related mortality
Time Frame: 6 months
Hospital census data
6 months
All-cause mortality
Time Frame: 6 months
Hospital census data
6 months

Collaborators and Investigators

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

Sponsor

Florida Atlantic University

Investigators

  • Principal Investigator: Richard D Shih, MD, Florida Atlantic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1903012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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