NCT05807724

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

March 29, 2023

Last Update Submit

February 21, 2025

Conditions

FallFall InjuryEmergencies

Keywords

Geriatric

Outcome Measures

Primary Outcomes (2)

  • Recurrent fall requiring ED revisit at 6 months

    Number of Participants with 6 months ED Returns

    6 months

  • Fall-related injury at 6 months

    Number of Participants with 6 months ED Returns

    6 months

Secondary Outcomes (3)

  • Specific fall-related injury at 6 months

    6 months

  • Fall-related mortality

    6 months

  • All-cause mortality

    6 months

Study Arms (3)

Current care

NO INTERVENTION

Current care at the ED

Phone-based fall-prevention strategy

EXPERIMENTAL

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

Home-visit fall prevention strategy

EXPERIMENTAL

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

Phone-based fall-prevention strategyOTHER

Written education material and Phone-Based Fall-Prevention Strategy

Phone-based fall-prevention strategy
Home-visit fall prevention strategyOTHER

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

Home-visit fall prevention strategy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Related Publications (16)

  • 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.

    PMID: 28874929BACKGROUND

  • 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.

    PMID: 32640131BACKGROUND

  • 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.

    PMID: 29746456BACKGROUND

  • 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.

    PMID: 27656914BACKGROUND

  • 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/

    PMID: 30896903BACKGROUND

  • 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.

    PMID: 21226685BACKGROUND

  • 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.

    PMID: 26958795BACKGROUND

  • 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.

    PMID: 25212122BACKGROUND

  • 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.

    PMID: 29065212BACKGROUND

  • 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.

    PMID: 18250292BACKGROUND

  • 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.

    PMID: 25700584BACKGROUND

  • 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.

    PMID: 33010956BACKGROUND

  • 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.

    PMID: 29534531BACKGROUND

  • 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.

    PMID: 29272029BACKGROUND

  • 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.

    PMID: 32854965BACKGROUND

  • 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.

    PMID: 31994723BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard D Shih, MD

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)