NCT02356211

Brief Summary

Objective To reduce subsequent falls following Multifactorial Falls Assessment Design: Prospective Case Control Population: Frail elderly Veteran outpatient population referred for falls assessment Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic patients followed for 1 year and outcomes compared to Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

August 1, 2008

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

8.4 years

First QC Date

January 31, 2015

Results QC Date

January 13, 2017

Last Update Submit

March 2, 2020

Conditions

Keywords

falls

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experienced Falls

    Number of participants who experienced falls in 12 months, based on self-recall and telephone interview.

    12 months

Study Arms (2)

Treatment

EXPERIMENTAL

Geriatric Multifactorial Falls Assessment Clinic

Other: Multifactorial Falls Assessment

Control

NO INTERVENTION

Geriatric Evaluation and Management Service (GEM)

Interventions

The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIATRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year.

Also known as: Falls Clinic
Treatment

Eligibility Criteria

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

You may qualify if:

  • Community-dwelling frail elderly with history of fall

You may not qualify if:

  • Severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TVHS Nashville Campus

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

  • Michael YL, Whitlock EP, Lin JS, Fu R, O'Connor EA, Gold R; US Preventive Services Task Force. Primary care-relevant interventions to prevent falling in older adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 21;153(12):815-25. doi: 10.7326/0003-4819-153-12-201012210-00008.

  • Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.

  • Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.

  • Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.

  • 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.

Limitations and Caveats

Fall rates determined by patient recall at 1 year by telephone interview. All patients were consented so advanced demented patients were not included in the intervention. Falls e-consults were limited by EMR information and provider discretion

Results Point of Contact

Title
James S. Powers MD, Clinical Associate Director, GRECC
Organization
TVHS GRECC, Nashville TN

Study Officials

  • James Powers, MD

    TVHS GRECC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Director, TVHS GRECC

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 5, 2015

Study Start

August 1, 2008

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 10, 2020

Results First Posted

January 31, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Per Va IRB, no personal identifiers including age \>89 can be shared. Aggregate data published: Powers JS, Samuels LR, Hu JR, Roumie CL. Veterans Geriatric Multifactorial Falls Assessment Clinic is Associated with Lower Fall Rate . J Gerontology and Aging Research 2017;1:102.

Locations