Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
Location status: Recruiting
Location contact
Alexander J Garbin, PhD DPT
CONTACT
Alexander J Garbin, PhD DPT
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06573983
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045-7211, United States
Location status: Recruiting
Alexander J Garbin, PhD DPT
CONTACT
Alexander J Garbin, PhD DPT
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Alexander J Garbin, PhD DPT
CONTACT
Jennifer E Stevens-Lapsley, PhD
CONTACT
VA Office of Research and Development
Fed
Development of a Fall Risk Identification and Management Model for Older Veterans
Acronym: FRIM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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