Fall Risk Identification and Management for Older Veterans

NCT ID: NCT06573983

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2029-09-30

Brief Summary

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.

Detailed 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.

Conditions

Fall Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fall Risk Identification and Management Model

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 Type: EXPERIMENTAL

Strengthening (Physical Therapy, Gerofit)

Intervention Type: OTHER

Individuals with physical fall risk will be referred to strengthening interventions available within the VHA. These may include Physical Therapy or Gerofit (a supervised exercise program).

Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy)

Intervention Type: OTHER

Individuals with psychological fall risk will be referred psychological interventions such as cognitive behavioral therapy, which focuses on guided talking. This can be performed by VHA occupational therapists and clinical psychologists.

Medication Reconciliation (Clinical Pharmacology)

Intervention Type: OTHER

Individuals with pharmacological fall risk will be referred to clinical pharmacology for medication reconciliation. This includes examining the current medication list and deprescribing medications, if appropriate.

Home Safety Modification (Occupational Therapy)

Intervention Type: OTHER

Individuals with environmental fall risk will be referred to occupational therapy for home safety assessments and modifications. This will involve modifying components within the home to reduce potential fall risk factors.

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Strengthening (Physical Therapy, Gerofit)

Individuals with physical fall risk will be referred to strengthening interventions available within the VHA. These may include Physical Therapy or Gerofit (a supervised exercise program).

Intervention Type: OTHER

Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy)

Individuals with psychological fall risk will be referred psychological interventions such as cognitive behavioral therapy, which focuses on guided talking. This can be performed by VHA occupational therapists and clinical psychologists.

Intervention Type: OTHER

Medication Reconciliation (Clinical Pharmacology)

Individuals with pharmacological fall risk will be referred to clinical pharmacology for medication reconciliation. This includes examining the current medication list and deprescribing medications, if appropriate.

Intervention Type: OTHER

Home Safety Modification (Occupational Therapy)

Individuals with environmental fall risk will be referred to occupational therapy for home safety assessments and modifications. This will involve modifying components within the home to reduce potential fall risk factors.

Intervention Type: OTHER

Eligibility Criteria

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 (Aim 1); Positive screen on at least one fall risk factor assessment (Aim 2)
• 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, with the intention of reducing a FRIM fall risk factor, within the past 2 months
• Currently using a wheelchair for mobilization
• If it is in the opinion of the study staff that the participant would be at an increased suicide risk due to study procedures

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander J Garbin, PhD DPT

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexander J Garbin, PhD DPT

Role: CONTACT

Alexander.Garbin@va.gov

(563) 340-7121

Jennifer E Stevens-Lapsley, PhD

Role: CONTACT

Jennifer.Stevens-Lapsley@va.gov

(303) 949-9304

Facility Contacts

Alexander J Garbin, PhD DPT

Role: primary

Alexander.Garbin@va.gov

563-340-7121

Other Identifiers

E5024-W

Identifier Type: -

Identifier Source: org_study_id