search
Back to results

Geriatric Emergency Department Fall Injury Prevention Project (GREAT-FALL)

Primary Purpose

Fall, Fall Injury, Emergencies

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone-based fall-prevention strategy
Home-visit fall prevention strategy
Sponsored by
Florida Atlantic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall focused on measuring Geriatric

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 CHF hospitalizations in past 6 months), end stage emphysema (two or more COPD 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)

Sites / Locations

  • Delray Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Current care

Phone-based fall-prevention strategy

Home-visit fall prevention strategy

Arm Description

Current care at the ED

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.

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.

Outcomes

Primary Outcome Measures

Recurrent fall requiring ED revisit at 6 months
Number of Participants with 6 months ED Returns
Fall-related injury at 6 months
Number of Participants with 6 months ED Returns

Secondary Outcome Measures

Specific fall-related injury at 6 months
Number of Participants with 6 months ED Returns
Fall-related mortality
Hospital census data
All-cause mortality
Hospital census data

Full Information

First Posted
March 29, 2023
Last Updated
May 19, 2023
Sponsor
Florida Atlantic University
search

1. Study Identification

Unique Protocol Identification Number
NCT05807724
Brief Title
Geriatric Emergency Department Fall Injury Prevention Project
Acronym
GREAT-FALL
Official Title
Geriatric Emergency Department Fall Injury Prevention Project
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Atlantic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 Current emergency department care STEADI recommendations administered via phone at 14 days 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Fall Injury, Emergencies
Keywords
Geriatric

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Current care
Arm Type
No Intervention
Arm Description
Current care at the ED
Arm Title
Phone-based fall-prevention strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Home-visit fall prevention strategy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Phone-based fall-prevention strategy
Intervention Description
Written education material and Phone-Based Fall-Prevention Strategy
Intervention Type
Other
Intervention Name(s)
Home-visit fall prevention strategy
Intervention Description
Written education material and Home visit-Based Fall-Prevention Strategy
Primary Outcome Measure Information:
Title
Recurrent fall requiring ED revisit at 6 months
Description
Number of Participants with 6 months ED Returns
Time Frame
6 months
Title
Fall-related injury at 6 months
Description
Number of Participants with 6 months ED Returns
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Specific fall-related injury at 6 months
Description
Number of Participants with 6 months ED Returns
Time Frame
6 months
Title
Fall-related mortality
Description
Hospital census data
Time Frame
6 months
Title
All-cause mortality
Description
Hospital census data
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 CHF hospitalizations in past 6 months), end stage emphysema (two or more COPD 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard D Shih, MD
Phone
561-733-5934
Email
rshih@health.fau.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Scott M Alter, MD
Phone
561-733-5934
Email
alters@health.fau.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Shih, MD
Organizational Affiliation
Florida Atlantic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28874929
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.
Results Reference
background
PubMed Identifier
32640131
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.
Results Reference
background
PubMed Identifier
29746456
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.
Results Reference
background
PubMed Identifier
27656914
Citation
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.
Results Reference
background
PubMed Identifier
30896903
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/
Results Reference
background
PubMed Identifier
21226685
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.
Results Reference
background
PubMed Identifier
26958795
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.
Results Reference
background
PubMed Identifier
25212122
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.
Results Reference
background
PubMed Identifier
29065212
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.
Results Reference
background
PubMed Identifier
18250292
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.
Results Reference
background
PubMed Identifier
25700584
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.
Results Reference
background
PubMed Identifier
33010956
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.
Results Reference
background
PubMed Identifier
29534531
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.
Results Reference
background
PubMed Identifier
29272029
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.
Results Reference
background
PubMed Identifier
32854965
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.
Results Reference
background
PubMed Identifier
31994723
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.
Results Reference
background

Learn more about this trial

Geriatric Emergency Department Fall Injury Prevention Project

We'll reach out to this number within 24 hrs