Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay: A QURE Virtual Patient Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- QURE virtual patient clinical score difference
研究概览
简要总结
This is a national-level research study of neurologists and dementia specialists. The purpose of this study is to assess the clinical evaluation and management recommendations made by practicing providers for patient simulations with symptoms of cognitive decline.
详细描述
QURE Healthcare will recruit a nationwide sample of neurologists and dementia specialists to assess the clinical evaluation and management potential of a novel diagnostic tool. The results of this study are expected to contribute to improved quality of care for patients with symptoms of Alzheimer's disease. Findings from this study will be submitted to a national journal for peer-reviewed publication. This study plans to enroll at least 150 healthcare providers.
This study will evaluate the clinical utility of Alzheimer's disease assay by analyzing improvement in the quality of physician decision-making regarding patients with symptoms of Alzheimer's disease, using a validated patient-simulation-based measurement approach, to achieve the following:
- Measure variation in clinical decisions among practicing neurologists, specifically in how they detect, measure, and manage Alzheimer's disease in patients with symptoms and/or risk factors of cognitive decline.
- Determine whether education on the Alzheimer's disease assay with accompanying test results leads to changes in clinical decision-making with regard to follow-up testing (e.g., CSF analysis, PET imaging), diagnostic accuracy, and treatment recommendations.
- Model whether the use of the Alzheimer's disease assay leads to higher-value and/or lower-cost care decisions (including follow-up testing, diagnostics, and treatment) that can lead to more efficient care.
- Determine whether the Alzheimer's disease assay results differentially impact treatment decisions for different patient types (use cases).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Board-certified in neurology for at least two years (and no more than 35 years
- •Average at least 20 hours per week of clinical and patient care duties over the past six months
- •Routinely evaluate patients at risk for Alzheimer's disease
- •Practicing in the United States
- •Able to read English
- •Access to the internet
- •Not participating in a clinical research study of the AD assay
- •Informed, signed, and voluntarily consented to participate in this study
排除标准
- •Board-certified in neurology for less than two years
- •Board certification in neurology over 35 years ago
- •Unable to read English
- •Unable to access the internet
- •Not practicing in the United States
- •Not averaging at least 20 hours per week of clinical or patient care duties over the past six months
- •Participating in a clinical research study of the AD assay
- •Do not voluntarily consent to participate in this study
研究组 & 干预措施
Control
Control participants will complete two rounds of three virtual patient cases. In both rounds, control participants will have access to standard of care diagnostic tools. They will not receive the AD assay test results.
Intervention
Intervention participants will complete two rounds of three virtual patient cases. In the first round, intervention participants will have access to standard of care diagnostic tools. They will then receive educational material about a novel AD assay. In the second round, they will automatically receive test results for the novel AD assay in addition to standard of care tools.
干预措施: Educational materials on the Alzheimer's disease assay (Other)
Intervention
Intervention participants will complete two rounds of three virtual patient cases. In the first round, intervention participants will have access to standard of care diagnostic tools. They will then receive educational material about a novel AD assay. In the second round, they will automatically receive test results for the novel AD assay in addition to standard of care tools.
干预措施: Alzheimer's disease assay results (Other)
结局指标
主要结局
QURE virtual patient clinical score difference
时间窗: Up to 12 months
Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of symptoms of cognitive decline, as measured by the participants' diagnostic and treatment case scores. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
Change in follow-up decisions (QURE scored-based) after receiving AD assay results
时间窗: Up to 12 months
Assessing changes in follow-up decisions (via QURE case domain scores) among intervention providers after they receive the results of the novel AD assay in the second round of case administration. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
次要结局
- Variation in QURE virtual patient case baseline scores(Up to 12 months)
- Difference in QURE virtual patient case scores by case type(Up to 12 months)
研究者
Trever Burgon, PhD
Principal Investigator
Qure Healthcare, LLC