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

F

Florida Atlantic University

Status

Completed

Conditions

Fall Injury
Emergencies
Fall

Treatments

Other: Home-visit fall prevention strategy
Other: Phone-based fall-prevention strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT05807724
1903012

Details and patient eligibility

About

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).

Full 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)

Enrollment

644 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

644 participants in 3 patient groups

Current care
No Intervention group
Description:
Current care at the ED
Phone-based fall-prevention strategy
Experimental group
Description:
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.
Treatment:
Other: Phone-based fall-prevention strategy
Home-visit fall prevention strategy
Experimental group
Description:
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.
Treatment:
Other: Home-visit fall prevention strategy

Trial contacts and locations

1

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Central trial contact

Scott M Alter, MD; Richard D Shih, MD

Data sourced from clinicaltrials.gov

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