Fall Risk Management for Older Veterans

(FRIM Trial)

Overseen By Jennifer E Stevens-Lapsley, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological diagnosis, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

108 Participants Needed

Trial Summary

What is the purpose of this trial?

Falls are a common occurrence among older adults, and Veterans have an even higher risk of falling compared to non-Veterans. These falls often lead to severe health consequences, including traumatic brain injuries, hip fractures, emergency visits, hospitalizations, and even death. It is crucial to prioritize fall prevention in order to reduce injuries and enable older Veterans to age comfortably at home. Although current fall prevention programs in the Veterans Health Administration primarily focus on inpatient care and nursing homes, there is a pressing need to address falls among older Veterans living independently in the community. The proposed VA-specific Fall Risk Identification and Management (FRIM) model aims to proactively prevent falls in older Veterans who receive primary care, effectively reducing the occurrence of adverse health events associated with falls. By placing emphasis on prevention rather than reacting after falls have already happened, this initiative seeks to significantly enhance the overall well-being of older Veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Fall Risk Identification and Management treatment for older veterans?

Research shows that systematic fall risk assessment and targeted interventions, such as exercise programs and environmental hazard reduction, can significantly reduce fall rates in older adults. These strategies are part of effective fall reduction programs, which have been supported by large studies and expert guidelines. ^{1 2 3 4 5}

Is the Fall Risk Management treatment safe for older veterans?

The research does not provide specific safety data for the Fall Risk Management treatment, but it highlights the importance of fall prevention and management in older adults, suggesting that structured fall prevention strategies are generally considered safe and beneficial. ^{6 7 8 9 10}

How does the Fall Risk Identification and Management treatment differ from other treatments for fall risk in older veterans?

The Fall Risk Identification and Management treatment is unique because it emphasizes early screening to detect risk factors, tailored interventions, and ensuring adherence to these interventions by older adults, which is not always the focus of other treatments. This approach involves both healthcare professionals and patients, aiming to bridge the gap between recommended practices and current clinical activities. ^{2 3 11 12 13}

Research Team

Alexander J Garbin, PhD DPT

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

This trial is for older Veterans who are at risk of falling and live independently. It's designed to help them avoid falls and the serious injuries that can result. To join, they should be receiving primary care through the Veterans Health Administration.

Inclusion Criteria

Positive screen on at least two fall risk factor assessments

I am 65 years old or older.

Access to telehealth

Exclusion Criteria

Life expectancy <12 months, as determined by PCP

I have a neurological condition like stroke, MS, or Parkinson's.

Moderate cognitive impairment (<13 on telephone Montreal Cognitive Assessment (MoCA-BLIND) or <18 on MoCA Full administered during clinic visit in the previous 3 months)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Model Refinement

Refinement of the FRIM model by gathering feedback from Veterans and clinicians through qualitative interviews following a small field test.

12 weeks

Multiple visits (virtual and in-person)

Feasibility Pilot Study

Conducting a randomized controlled feasibility pilot study to evaluate the feasibility, acceptability, and candidate efficacy outcomes of the FRIM model.

1 year

Regular telehealth visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including tracking of falls and injurious falls.

1.25 years

Weekly self-reports via the Annie-App

Treatment Details

Interventions

• Fall Risk Identification and Management

Trial Overview The FRIM model being tested includes physical therapy exercises to strengthen muscles, reviews of medications by clinical pharmacologists, changes at home recommended by occupational therapists to make it safer, and cognitive behavioral therapy to improve mental health.

Participant Groups

Group I: Fall Risk Identification and Management Model Experimental Treatment 4 Interventions

Participants will be assessed on four fall risk factors including physical, psychological, pharmacological, and environmental. If a participant screens positive for a fall risk factor, they will then be referred to an existing VHA care pathway. The care pathways include: strengthening via physical therapy or Gerofit for physical fall risk, cognitive behavioral therapy via clinical psychology or occupational therapy for psychological fall risk, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk.

Group II: Standard of care Active Control 1 Intervention

This group will received current standard of care within the Rocky Mountain Regional GeriPACT clinic.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Older patients who had a fall in the three months before hospitalization showed a greater concern for fall prevention and engaged in more fall prevention behaviors, but they also felt less confident in their ability to prevent falls.

Positive associations were found between patients' perceptions of fall risk and their engagement in fall prevention activities, suggesting that improving patient awareness and confidence could enhance existing fall prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older hospital inpatients' fall risk factors, perceptions, and daily activities to prevent falling. Kiyoshi-Teo, H., Northrup-Snyder, K., Cohen, DJ., et al.[2019]

In a study of 250 elderly patients over 60 years old, the prevalence of falls was found to be 27.6%, with a significant correlation to age, particularly in those over 80 years old, and a higher incidence in females compared to males.

Key risk factors for falls included visual impairment, postural hypotension, and having more than three risk factors, indicating that simple clinical assessments can effectively identify high-risk individuals for fall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Fall Risk in Elderly Rural Population. Geetha, J., Sakthivadivel, V., Gaur, A.[2022]

Falls among older adults are a major health issue, but identifying and addressing risk factors like weakness and unsteady gait can significantly reduce fall rates.

Effective fall prevention programs include systematic risk assessments, targeted interventions, exercise programs, and environmental hazard reductions, supported by extensive clinical trial data and expert guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Falls in older people: epidemiology, risk factors and strategies for prevention. Rubenstein, LZ.[2022]

Falls are a significant health risk for older adults, with 30-40% of those over 65 experiencing at least one fall each year, leading to serious injuries and increased healthcare costs.

Key risk factors for falls include impaired balance and gait, polypharmacy, and a history of previous falls, along with demographic factors like age and gender, which clinicians should consider when managing fall risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for falls among older adults: a review of the literature. Ambrose, AF., Paul, G., Hausdorff, JM.[2022]

A study involving 1,819 inpatients at 6 Veterans Health Administration medical centers found that the veteran population is at a high risk for falls, particularly due to their older age and health conditions.

The Morse Fall Scale (MFS) was used to assess fall risk, highlighting the need for targeted interventions to prevent falls and related injuries among aging veterans in both acute and long-term care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veterans' fall risk profile: a prevalence study. Quigley, PA., Palacios, P., Spehar, AM.[2021]

The study analyzed data from approximately 4 million unique patients in the VA Healthcare system, revealing a four-fold increase in fall-related encounters among elderly veterans from FY 1997-2001, indicating a growing concern for fall injuries in this population.

Elderly veterans (over 65) were more likely to receive care in non-urgent settings and had higher co-morbid conditions, highlighting the need for targeted fall prevention strategies and comprehensive care for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using administrative data to track fall-related ambulatory care services in the Veterans Administration Healthcare system. Luther, SL., French, DD., Powell-Cope, G., et al.[2019]

In a study of 212,617 hospitalized patients, orthopedic patients had a significantly higher fall rate (3.12%) compared to other patients (1.80%), highlighting their increased vulnerability, especially among older individuals.

Falls leading to serious injuries were most common between 1-7 a.m., suggesting that targeted fall prevention strategies during these hours could be crucial for improving patient safety in orthopedic wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of falls in orthopedic patients during hospitalization. Kobayashi, K., Ando, K., Inagaki, Y., et al.[2018]

In a study of 14,831 older adults, veterans experienced more noninjurious falls (26.6%) compared to nonveterans (24.0%), but had fewer fall-related injuries (8.9% vs. 12.3%).

Regular physical activity appears to lower the odds of noninjurious falls among veterans, suggesting that staying active may help reduce fall risks as they age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Falls Among a National Cohort of Older Veterans. Marciniak, D., Alexander, NB., Hoffman, GJ.[2021]

In a study of 250 older patients who fell, it was found that female sex and regular medicine use were significant predictors of different types of falls, highlighting the need for targeted prevention strategies.

The research suggests that healthcare providers should carefully review medication prescriptions for older adults, as polypharmacy may increase the risk of falls, which can lead to serious injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-dependent physiological changes, medicines and sex-influenced types of falls. Kusljic, S., Perera, S., Manias, E.[2019]

Falls are a common and serious issue for older adults, and at least 30% of these falls are likely preventable with proper risk management and assessment strategies.

Current practices in Germany do not routinely include structured fall assessments in outpatient and inpatient services, which could lead to legal challenges for institutions that fail to implement adequate fall prevention measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Falling in geriatrics. Diagnosis and treatment]. Becker, C., Rapp, K.[2021]

Effective fall risk management for older adults requires early screening, tailored interventions, and active participation from both healthcare professionals and the individuals at risk.

Despite available guidelines and financial incentives to promote evidence-based practices, there is still a significant gap in the implementation of fall prevention strategies in clinical settings, highlighting the need for improved adoption methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complexities of fall prevention in clinical settings: a commentary. Shubert, TE., Smith, ML., Prizer, LP., et al.[2014]

Older adults often experience skin injuries from falls, and chronic wounds can further increase their risk of falling, highlighting the importance of comprehensive assessments in skin and wound care.

Effective strategies to reduce falls in older adults should focus on identifying risk factors and maintaining skin integrity, which are essential for improving patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults, Falls, and Skin Integrity. Cheung, C.[2022]

A study of 137 seniors revealed that male veterans are at a higher risk of falling and sustaining injuries compared to the general senior population.

While senior women have a lower risk of falling and injury than veterans, they are still at a higher risk than non-veteran senior men, highlighting the need for targeted fall prevention strategies for these specific groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of the impact of gender and veteran status on falls among community-dwelling seniors: implications for targeting falls prevention activities. Weeks, LE.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Older hospital inpatients' fall risk factors, perceptions, and daily activities to prevent falling. [2019]

2. Romania pubmed.ncbi.nlm.nih.gov

Assessment of Fall Risk in Elderly Rural Population. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Falls in older people: epidemiology, risk factors and strategies for prevention. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Risk factors for falls among older adults: a review of the literature. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Veterans' fall risk profile: a prevalence study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Using administrative data to track fall-related ambulatory care services in the Veterans Administration Healthcare system. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Characteristics of falls in orthopedic patients during hospitalization. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Falls Among a National Cohort of Older Veterans. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Age-dependent physiological changes, medicines and sex-influenced types of falls. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Falling in geriatrics. Diagnosis and treatment]. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Complexities of fall prevention in clinical settings: a commentary. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Older Adults, Falls, and Skin Integrity. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

An examination of the impact of gender and veteran status on falls among community-dwelling seniors: implications for targeting falls prevention activities. [2019]