Clinical trial NCT05807724: Geriatric Emergency Department Fall Injury Prevention Project
Official title: Geriatric Emergency Department Fall Injury Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Fall Injury
Emergencies
Keywords: Geriatric
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 644
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Recurrent fall requiring ED revisit at 6 months
timeFrame: 6 months
measure: Fall-related injury at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Specific fall-related injury at 6 months
timeFrame: 6 months
measure: Fall-related mortality
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
Study officials:
affiliation: Florida Atlantic University
name: Richard D Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
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