Clinical trial NCT06573983: Fall Risk Identification and Management for Older Veterans
Official title: Development of a Fall Risk Identification and Management Model for Older Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall Risk
Keywords: Falls
Telerehabilitation
Multifactorial
Preventative
Personalized
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-08-27
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two phases to the study. The first phase will include refinement of the intervention by examining quantitative and qualitative data from a small number of participants with no control. The second phase will be a randomized feasibility pilot where the intervention group will be compared to standard of care.
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Participant recruitment
timeFrame: Program start
measure: Participant retention
timeFrame: Program start - 1 year post baseline
Secondary outcomes:
measure: Fall risk identification burden
timeFrame: Program start, Program end (average of 12 weeks)
measure: Fall risk management burden
timeFrame: Program start - Program end (average of 12 weeks)
measure: Theoretical framework of acceptability questionnaire
timeFrame: Program end (average of 12 weeks)
measure: 3 key questions
timeFrame: Program start
measure: 5 times sit to stand
timeFrame: Program start, 1 year after intervention end (average of 1.25 years post baseline)
measure: Survey of Activities and Fear of Falling in the Elderly
timeFrame: Program start, 1 year after intervention end (average of 1.25 years post baseline)
measure: Screening Tool of Older Persons Prescriptions in older adults with high fall risk (STOPPFall)
timeFrame: Program start, 1 year after intervention end (average of 1.25 years post baseline)
measure: Home Falls and Accidents Screening Tool (HOME FAST)
timeFrame: Program start, 1 year after intervention end (average of 1.25 years post baseline)
measure: Unique number of falls.
timeFrame: Through study completion (average of 1.25 years)
measure: Median cumulative number of falls
timeFrame: Through study completion (average of 1.25 years)
measure: Time to first fall
timeFrame: Through study completion (average of 1.25 years)
measure: Unique number of injurious falls
timeFrame: Through study completion (average of 1.25 years)
measure: Median cumulative number of injurious falls
timeFrame: Through study completion (average of 1.25 years)
measure: Time to first injurious fall
timeFrame: Through study completion (average of 1.25 years)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Alexander J Garbin, PhD DPT
role: PRINCIPAL_INVESTIGATOR
References: