Geriatric Emergency Department Fall Injury Prevention Project

Emergencies Clinical Trial

— GREAT-FALL  

Official title:

Geriatric Emergency Department Fall Injury Prevention Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807724
• Other study ID #: 1903012
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Florida Atlantic University
• Contact: Richard D Shih, MD
• Phone: 561-733-5934
• Email: rshih[@]health.fau.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Fall
• Fall Injury
• Wounds and Injuries

Intervention

Other:
• Phone-based fall-prevention strategy
Written education material and Phone-Based Fall-Prevention Strategy
• Home-visit fall prevention strategy
Written education material and Home visit-Based Fall-Prevention Strategy

Locations

Country	Name	City	State
United States	Delray Medical Center	Delray Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Atlantic University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent fall requiring ED revisit at 6 months	Number of Participants with 6 months ED Returns	6 months
Primary	Fall-related injury at 6 months	Number of Participants with 6 months ED Returns	6 months
Secondary	Specific fall-related injury at 6 months	Number of Participants with 6 months ED Returns	6 months
Secondary	Fall-related mortality	Hospital census data	6 months
Secondary	All-cause mortality	Hospital census data	6 months