CClinicalTrials.gg
CompletedNCT05807724GREAT-FALLUpdated Feb 24, 2025

Geriatric Emergency Department Fall Injury Prevention Project

An interventional study of Phone-based fall-prevention strategy and Home-visit fall prevention strategy in Fall, Fall Injury and Emergencies, sponsored by Florida Atlantic University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Florida Atlantic University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
644
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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).

Read the 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)

02

Conditions studied

  • Fall
  • Fall Injury
  • Emergencies

Keywords

  • Geriatric
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 644 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Florida Atlantic University is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
644 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherPhone-based fall-prevention strategy

    Written education material and Phone-Based Fall-Prevention Strategy

  • OtherHome-visit fall prevention strategy

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

06

What researchers measure

Primary outcomes

  1. Recurrent fall requiring ED revisit at 6 months

    Number of Participants with 6 months ED Returns

    Time frame: 6 months

  2. Fall-related injury at 6 months

    Number of Participants with 6 months ED Returns

    Time frame: 6 months

Secondary outcomes

  1. Specific fall-related injury at 6 months

    Number of Participants with 6 months ED Returns

    Time frame: 6 months

  2. Fall-related mortality

    Hospital census data

    Time frame: 6 months

  3. All-cause mortality

    Hospital census data

    Time frame: 6 months

07

Study locations

1 site
  • Delray Medical Center
    Delray Beach, Florida 33484, United States
08

References and documents

Publications

  • Shankar KN, Liu SW, Ganz DA. Trends and Characteristics of Emergency Department Visits for Fall-Related Injuries in Older Adults, 2003-2010. West J Emerg Med. 2017 Aug;18(5):785-793. doi: 10.5811/westjem.2017.5.33615. Epub 2017 Jul 14. PubMed 28874929 ↗
  • Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183. PubMed 32640131 ↗
  • Burns E, Kakara R. Deaths from Falls Among Persons Aged >/=65 Years - United States, 2007-2016. MMWR Morb Mortal Wkly Rep. 2018 May 11;67(18):509-514. doi: 10.15585/mmwr.mm6718a1. PubMed 29746456 ↗
  • Bergen G, Stevens MR, Burns ER. Falls and Fall Injuries Among Adults Aged >/=65 Years - United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Sep 23;65(37):993-998. doi: 10.15585/mmwr.mm6537a2. PubMed 27656914 ↗
  • National Prevention Council. Healthy Aging in Action: Advancing the National Prevention Strategy [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK538955/ PubMed 30896903 ↗
  • Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x. PubMed 21226685 ↗
  • Crandall M, Duncan T, Mallat A, Greene W, Violano P, Christmas AB, Barraco R. Prevention of fall-related injuries in the elderly: An Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2016 Jul;81(1):196-206. doi: 10.1097/TA.0000000000001025. PubMed 26958795 ↗
  • Jung D, Shin S, Kim H. A fall prevention guideline for older adults living in long-term care facilities. Int Nurs Rev. 2014 Dec;61(4):525-33. doi: 10.1111/inr.12131. Epub 2014 Sep 12. PubMed 25212122 ↗
  • Kruschke C, Butcher HK. Evidence-Based Practice Guideline: Fall Prevention for Older Adults. J Gerontol Nurs. 2017 Nov 1;43(11):15-21. doi: 10.3928/00989134-20171016-01. PubMed 29065212 ↗
  • Thurman DJ, Stevens JA, Rao JK; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: Assessing patients in a neurology practice for risk of falls (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2008 Feb 5;70(6):473-9. doi: 10.1212/01.wnl.0000299085.18976.20. PubMed 18250292 ↗
  • Phelan EA, Mahoney JE, Voit JC, Stevens JA. Assessment and management of fall risk in primary care settings. Med Clin North Am. 2015 Mar;99(2):281-93. doi: 10.1016/j.mcna.2014.11.004. PubMed 25700584 ↗
  • Davenport K, Alazemi M, Sri-On J, Liu S. Missed Opportunities to Diagnose and Intervene in Modifiable Risk Factors for Older Emergency Department Patients Presenting After a Fall. Ann Emerg Med. 2020 Dec;76(6):730-738. doi: 10.1016/j.annemergmed.2020.06.020. Epub 2020 Sep 30. PubMed 33010956 ↗
  • Cheng P, Tan L, Ning P, Li L, Gao Y, Wu Y, Schwebel DC, Chu H, Yin H, Hu G. Comparative Effectiveness of Published Interventions for Elderly Fall Prevention: A Systematic Review and Network Meta-Analysis. Int J Environ Res Public Health. 2018 Mar 12;15(3):498. doi: 10.3390/ijerph15030498. PubMed 29534531 ↗
  • Biese KJ, Busby-Whitehead J, Cai J, Stearns SC, Roberts E, Mihas P, Emmett D, Zhou Q, Farmer F, Kizer JS. Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial. J Am Geriatr Soc. 2018 Mar;66(3):452-458. doi: 10.1111/jgs.15142. Epub 2017 Dec 22. PubMed 29272029 ↗
  • Goldberg EM, Marks SJ, Resnik LJ, Long S, Mellott H, Merchant RC. Can an Emergency Department-Initiated Intervention Prevent Subsequent Falls and Health Care Use in Older Adults? A Randomized Controlled Trial. Ann Emerg Med. 2020 Dec;76(6):739-750. doi: 10.1016/j.annemergmed.2020.07.025. Epub 2020 Aug 25. PubMed 32854965 ↗
  • Ouslander JG, Reyes B, Diaz S, Engstrom G. Thirty-Day Hospital Readmissions in a Care Transitions Program for High-Risk Older Adults. J Am Geriatr Soc. 2020 Jun;68(6):1307-1312. doi: 10.1111/jgs.16314. Epub 2020 Jan 29. PubMed 31994723 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05807724
Lead sponsor
Florida Atlantic University
Responsible party
Sponsor
First posted
Apr 11, 2023
Start date
Apr 1, 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 24, 2025

Study contacts

Richard D Shih, MD
principal investigator · Florida Atlantic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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