GREAT-FALL: Geriatric Emergency Department Fall Injury Prevention Project

Sponsor
Florida Atlantic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05807724
Collaborator
(none)
1,600
1
3
18
88.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Phone-based fall-prevention strategy
  • Other: Home-visit fall prevention strategy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Geriatric Emergency Department Fall Injury Prevention Project
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recurrent fall requiring ED revisit at 6 months [6 months]

    Number of Participants with 6 months ED Returns

  2. Fall-related injury at 6 months [6 months]

    Number of Participants with 6 months ED Returns

Secondary Outcome Measures

  1. Specific fall-related injury at 6 months [6 months]

    Number of Participants with 6 months ED Returns

  2. Fall-related mortality [6 months]

    Hospital census data

  3. All-cause mortality [6 months]

    Hospital census data

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 CHF hospitalizations in past 6 months), end stage emphysema (two or more COPD 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Delray Medical Center Delray Beach Florida United States 33484

Sponsors and Collaborators

  • Florida Atlantic University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT05807724
Other Study ID Numbers:
  • 1903012
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Florida Atlantic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2023