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Completed

NCT Number: NCT05807724

Geriatric Emergency Department Fall Injury Prevention Project

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delray Medical Center

Delray Beach, Florida, 33484, United States

About this study

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

  • Current emergency department care
  • STEADI recommendations administered via phone at 14 days
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phone-based fall-prevention strategy

Other

Written education material and Phone-Based Fall-Prevention Strategy

Home-visit fall prevention strategy

Other

Written education material and Home visit-Based Fall-Prevention Strategy

Primary outcomes

  1. Recurrent fall requiring ED revisit at 6 months

    Time frame: 6 months

    Number of Participants with 6 months ED Returns

  2. Fall-related injury at 6 months

    Time frame: 6 months

    Number of Participants with 6 months ED Returns

Secondary outcomes

  1. Specific fall-related injury at 6 months

    Time frame: 6 months

    Number of Participants with 6 months ED Returns

  2. Fall-related mortality

    Time frame: 6 months

    Hospital census data

  3. All-cause mortality

    Time frame: 6 months

    Hospital census data

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Registry information

Acronym: GREAT-FALL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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