Fall Risk Identification and Management for Older Veterans

Not Applicable

Recruiting

• Conditions: Fall Risk

• Registration Number: NCT06573983
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Study Start: 2024-11-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2028-12-31
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant recruitment	Program start	Participant recruitment will be tracked as part of feasibility. It will be determined as the proportion of Veterans screened as eligible that are recruited.
Participant retention	Program start - 1 year post baseline	Participant retention will be tracked as part of feasibility. It will be determined as the 1-year retention rate of participants.

Secondary Outcome Measures

Name	Time	Method
Fall risk identification burden	Program start, Program end (average of 12 weeks)	Fall risk identification burden will be tracked as part of feasibility. It will be determined as the time to identify fall risk factors during telehealth visit.
5 times sit to stand	Program start, 1 year after intervention end (average of 1.25 years post baseline)	The 5 times sit to stand is a test of lower extremity strength, transitional movements, and balance. The test is scored based on the time to completed 5 sit to stand movements and is highly predictive of falls and injurious falls. A higher time indicates worse physical function and greater physical fall risk.
Screening Tool of Older Persons Prescriptions in older adults with high fall risk (STOPPFall)	Program start, 1 year after intervention end (average of 1.25 years post baseline)	Pharmacological fall risk will be identified via the number of medications prescribed on the Screening Tool of Older Persons Prescriptions in older adults with high fall risk. The number of medications prescribed will be collected from the participant's medical record. A higher score indicates more fall risk increasing drugs and greater pharmacological fall risk.
Fall risk management burden	Program start - Program end (average of 12 weeks)	Fall risk management burden will be tracked as part of feasibility. It will be determined as the time to complete fall risk factor management.
Theoretical framework of acceptability questionnaire	Program end (average of 12 weeks)	Acceptability will be measured using an established questionnaire based on the theoretical framework of acceptability. Responses on the questionnaire range from 1 (did not like, high burden) to 5 (strongly liked, low burden).
3 key questions	Program start	The 3 key questions include 1) whether the older adult feels unsteady when standing or walking, 2) worries about falling, 3) or has fallen in the past year. Participant responses of 'yes' or 'no' to each question will be recorded.
Home Falls and Accidents Screening Tool (HOME FAST)	Program start, 1 year after intervention end (average of 1.25 years post baseline)	The Home Falls and Accidents and Screening Tool is a questionnaire that assesses 25 potential home fall risk factors (e.g., slippery surfaces, lighting, etc.). A higher score indicates greater environmental fall risk.
Survey of Activities and Fear of Falling in the Elderly	Program start, 1 year after intervention end (average of 1.25 years post baseline)	This survey is a questionnaire that probes fear of falling and activity restriction of eleven activities. Fear of falling is scored based on the average worry to perform each activity ranging from 0 (not worried) to 3 (very worried). Activity restriction is scored by the number of activities that an individuals reports doing less than usual compared to three years ago. Additional questions probe whether activities are restricted due to fear of falling. Higher scores indicate greater psychological fall risk.
Unique number of falls.	Through study completion (average of 1.25 years)	Unique number of falls will be measured as a yes/no occurrence of any falls during the study. This will be measured using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.
Median cumulative number of falls	Through study completion (average of 1.25 years)	Median number of cumulative falls per Veteran will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.
Time to first fall	Through study completion (average of 1.25 years)	Time to first fall is a continuous measure of days to the first fall occurring within the study period. This will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.
Time to first injurious fall	Through study completion (average of 1.25 years)	Injurious falls will be defined as falls requiring medical attention. Time to first injurious fall is a continuous measure of days to the first injurious fall occurring within the study period. This will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.
Unique number of injurious falls	Through study completion (average of 1.25 years)	Injurious falls will be defined as falls requiring medical attention. Unique number of injurious falls will be measured as a yes/no occurrence of any injurious falls during the study. This will be measured using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.
Median cumulative number of injurious falls	Through study completion (average of 1.25 years)	Injurious falls will be defined as falls requiring medical attention. Median number of cumulative injurious falls per Veteran will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse.

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States