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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent falls among older Veterans living at home who receive primary care. It seeks to identify and manage risks through a new model called Fall Risk Identification and Management, which examines physical, psychological, medication, and home safety factors. Based on their needs, participants will receive referrals to existing care programs like physical therapy or home safety assessments. This trial is ideal for Veterans aged 65 and older who have a high risk of falling and can access telehealth services. As an unphased trial, it offers Veterans the chance to contribute to innovative fall prevention strategies tailored to their unique needs.

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 prior data suggests that the Fall Risk Identification and Management model is safe for older Veterans?

Research has shown that the Fall Risk Identification and Management (FRIM) model helps older Veterans by lowering their risk of falls. This method examines various risk factors, including physical and mental health, medications, and home safety. When risks are identified, participants receive guidance to existing care programs. For instance, they might engage in strength-building exercises or have professionals assess their home for safety issues.

As a model rather than a medication, it focuses on prevention rather than treatment. No direct evidence of negative effects exists because the model employs well-known care strategies already in use in healthcare. This suggests it is likely safe. The goal is to enhance safety and prevent falls rather than introduce new treatments that might pose safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tackles fall risk among older veterans with a comprehensive approach. Unlike standard care, which might focus on general support, this method assesses specific fall risk factors—physical, psychological, pharmacological, and environmental—and provides targeted interventions. For instance, if a veteran is at risk due to physical factors, they might receive physical therapy or join the Gerofit program. This personalized approach not only addresses the immediate risk but also connects participants to existing care pathways for long-term management, aiming to significantly reduce falls and improve overall health outcomes.

What evidence suggests that the Fall Risk Identification and Management model is effective for preventing falls in older Veterans?

Studies have shown that programs aimed at strengthening muscles can effectively reduce falls among older adults living in their communities. This trial tests the Fall Risk Identification and Management (FRIM) model as an experimental approach. It assesses various risk factors, including physical health, mental well-being, medications, and home safety. When a risk is identified, participants receive guidance on specific care options, such as physical therapy to build strength or home adjustments for safety. This method aims to prevent falls before they occur, helping older Veterans remain safe and independent. Research indicates that these targeted actions can decrease the likelihood of falls and related injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Alexander J Garbin, PhD DPT

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

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

Access to telehealth

I can have an adult with me during my physical exams.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10999312

Project Details - NIH RePORTER The proposed VA-specific Fall Risk Identification and Management (FRIM) model aims to proactively prevent falls in older Veterans who receive primary care, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06573983

Fall Risk Identification and Management for Older Veterans This phase will involve the collection of both qualitative and quantitative data to evaluate the feasibility, acceptability, and candidate efficacy outcomes of ...

3. ctv.veeva.com ctv.veeva.com/study/fall-risk-identification-and-management-for-older-veterans

Fall Risk Identification and Management for Older Veterans The proposed VA-specific Fall Risk Identification and Management (FRIM) model aims to proactively prevent falls in older Veterans who receive primary care.

4. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141700246

RRP 09-202 – HSR Study - VA Health Systems Research Studies have shown that fall prevention programs emphasizing muscle strength building have been effective in reducing the number of falls in community dwelling ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7554127/

Physical Activity and Falls among a National Cohort of ... Veterans reported more non-injurious falls (26.6% vs. 24.0%, p<0.002), but fewer fall-related injuries (8.9% vs 12.3%, p<0.001) than non-veterans.

6. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=17

Fall Prevention and Management for Older Adults About 25% of community-dwelling adults fall every year, resulting in annual medical costs of at least $19 billion in the United States.