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Fall Risk Identification and Management for Older Veterans (FRIM)

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VA Office of Research and Development

Status

Enrolling

Conditions

Fall Risk

Treatments

Other: Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy)
Other: Strengthening (Physical Therapy, Gerofit)
Other: Home Safety Modification (Occupational Therapy)
Other: Medication Reconciliation (Clinical Pharmacology)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06573983
E5024-W

Details and patient eligibility

About

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.

Full description

Falls among older adults pose a significant risk, leading to life-altering injuries and imposing substantial healthcare costs. There is a pressing need to develop fall prevention models within the Veterans Health Administration (VHA) considering Veterans are more likely to fall than their age-matched non-Veteran counterparts, likely secondary to higher rates of functional impairment and comorbidities. Extensive research has identified numerous fall risk factors across physical, psychological, pharmacological, and environmental domains. Further, screening tools and interventions have been developed to identify and manage these risk factors, offering insight on methods to intervene early and prevent falls in older Veterans. Primary care clinics within the VHA are well-positioned to play a crucial role in preventing falls. These clinics are frequently visited by older Veterans for routine care and are widely accessible across the country. However, fall risk assessment is often not included in the standard care provided by VHA primary care clinics, mainly due to barriers like limited time, competing medical priorities, and a lack of training. Consequently, there is a missed opportunity to address fall prevention. Therefore, the investigators are developing a personalized multifactorial model called Fall Risk Identification and Management (FRIM) to prevent falls in older Veterans seen within primary care by addressing known barriers that have limited the uptake of other fall prevention models. Specifically, the FRIM model follows a three-stage process: briefly screening for fall risk during routine primary care visits, conducting telehealth visits to identify specific fall risk factors, and referring Veterans to existing VHA care pathways with established interventions for managing identified risk factors. The objectives of this CDA-2 are to refine (Aim 1; Phase 1) and assess the feasibility (Aim 2; Phase 2) of the FRIM model in preparation for a future efficacy trial. The initial phase, Aim 1, focuses on refining the FRIM model by gathering feedback on each care pathway from Veterans and clinicians through qualitative interviews following a small field test. Additionally, the investigators will assess the impact of each care pathway on fall risk factor assessments. This phase aims to enhance the model based on the integration of perceptions and outcomes. Following the refinement of the FRIM model, Aim 2 entails conducting a randomized controlled feasibility pilot study. This phase will involve the collection of both qualitative and quantitative data to evaluate the feasibility, acceptability, and candidate efficacy outcomes of the FRIM model while comparing it to VHA standard of care.

Enrollment

108 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Screens positive for increased fall risk within GeriPACT, or generalPACT as needed, (answers "yes" to any of 3 screening questions)
  • 65 years of age and older
  • Positive screen on at least two fall risk factor assessments
  • Access to telehealth
  • Availability of an additional adult (e.g., caregiver or family member) to be present during the physical assessment

Exclusion criteria

  • Life expectancy <12 months, as determined by PCP
  • Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's Disease)
  • 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)
  • Unstable condition that precludes safe participation in structured exercise (e.g., recent deep vein thrombosis) if expected fall risk factor is physical, as determined by PCP or chart review
  • Participation in any intervention components of the FRIM model within the past 6 months
  • Currently using a wheelchair for mobilization

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 2 patient groups

Fall Risk Identification and Management Model
Experimental group
Description:
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.
Treatment:
Other: Medication Reconciliation (Clinical Pharmacology)
Other: Home Safety Modification (Occupational Therapy)
Other: Strengthening (Physical Therapy, Gerofit)
Other: Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy)
Standard of care
No Intervention group
Description:
This group will received current standard of care within the Rocky Mountain Regional GeriPACT clinic.

Trial contacts and locations

1

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Central trial contact

Alexander J Garbin, PhD DPT; Jennifer E Stevens-Lapsley, PhD

Data sourced from clinicaltrials.gov

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