Geriatric Emergency Department Fall Injury Prevention Project

NCT ID: NCT05807724

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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)

Conditions

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Fall Fall Injury Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Current care

Current care at the ED

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Phone-based fall-prevention strategy

Intervention Type OTHER

Written education material and Phone-Based Fall-Prevention Strategy

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.

Group Type EXPERIMENTAL

Home-visit fall prevention strategy

Intervention Type OTHER

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

Interventions

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Phone-based fall-prevention strategy

Written education material and Phone-Based Fall-Prevention Strategy

Intervention Type OTHER

Home-visit fall prevention strategy

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida Atlantic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard D Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Atlantic University

Locations

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Delray Medical Center

Delray Beach, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28874929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32640131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29746456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27656914 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 30896903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21226685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26958795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25212122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29065212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18250292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25700584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33010956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29534531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29272029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32854965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31994723 (View on PubMed)

Other Identifiers

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1903012

Identifier Type: -

Identifier Source: org_study_id

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