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临床试验/NCT06573983
NCT06573983招募中不适用

Development of a Fall Risk Identification and Management Model for Older Veterans

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
1
主要终点
Participant recruitment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Outcome assessors and investigators will be blinded to assignment during phase 2. Participants and care providers are unable to be blinded as delivery of treatment outside of standard of care will demonstrate group assignment.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Receives care within GeriPACT, or general PACT as needed (Aim 1); Receives care within general PACT (standard VHA primary care) (Aim 2)
  • •Screens positive for increased fall risk (answers "yes" to any of 3 screening questions)
  • •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

排除标准

  • •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

研究组 & 干预措施

Standard of care

No Intervention

This group will receive VHA primary care current standard of care.

Fall Risk Identification and Management Model

Experimental

Participants will be assessed on three fall risk factors including physical, 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, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk.

干预措施: Medication Reconciliation (Clinical Pharmacology) (Other)

Fall Risk Identification and Management Model

Experimental

Participants will be assessed on three fall risk factors including physical, 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, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk.

干预措施: Home Safety Modification (Occupational Therapy) (Other)

Fall Risk Identification and Management Model

Experimental

Participants will be assessed on three fall risk factors including physical, 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, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk.

干预措施: Strengthening (Physical Therapy, Gerofit) (Other)

结局指标

主要结局

Participant recruitment

时间窗: 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

时间窗: 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.

次要结局

  • Fall risk management burden(Program start - Program end (average of 12 weeks))
  • 30 second sit to stand(Program start, 1 year after intervention end (average of 1 year post baseline))
  • Falls Efficacy Scale - International (FES-I)(Program start, 1 year after intervention end (average of 1 year post baseline))
  • Screening Tool of Older Persons Prescriptions in older adults with high fall risk (STOPPFall)(Program start, 1 year after intervention end (average of 1 year post baseline))
  • Home Falls and Accidents Screening Tool Self-Report (HOME FAST - SR)(Program start, 1 year after intervention end (average of 1 year post baseline))
  • Unique number of falls.(Through study completion (average of 1 year))
  • Median cumulative number of falls(Through study completion (average of 1 year))
  • Time to first fall(Through study completion (average of 1 year))
  • Unique number of injurious falls(Through study completion (average of 1 year))
  • Median cumulative number of injurious falls(Through study completion (average of 1 year))
  • Time to first injurious fall(Through study completion (average of 1 year))
  • Fall risk identification burden(Program start, Program end (average of 12 weeks))
  • Theoretical framework of acceptability questionnaire(Program end (average of 12 weeks))
  • 3 key questions(Program start)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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