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| Name | Class |
|---|---|
| Beckman Coulter, Inc. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational materials on the Alzheimer's disease assay | Other | Between Round 1 and Round 2 virtual patient case administration, Intervention participants will receive educational materials describing the clinical validation and use cases of the Alzheimer's disease assay. These materials will approximate the type of information physicians would receive to introduce them to the Alzheimer's disease assay and may be comprised of a slide deck, fact sheet, sample test report, and/or example case scenarios. |
| Measure | Description | Time Frame |
|---|---|---|
| QURE virtual patient clinical score difference | 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). | Up to 12 months |
| Change in follow-up decisions (QURE scored-based) after receiving AD assay results | 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). | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in QURE virtual patient case baseline scores | Participants completing QURE virtual patients receive scores based upon the quality of care they provide. 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). This measure will assess the baseline levels of variation in the care of virtual patients with symptoms of cognitive decline among all participants, including by use case types. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trever Burgon, PhD | QURE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QURE Healthcare | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The study will enroll neurologists and dementia specialists practicing in the United States. Participants will be randomly assigned to either control or intervention arms upon enrollment. All eligible and consented participants will complete two rounds of three virtual patient simulations.
The intervention arm participants will receive educational material about the novel Alzheimer's disease assay after round 1 of data collection. After a waiting period, intervention arm participants will receive the results of the AD assay at the appropriate point in the virtual patient simulation. Control arm participants will not receive results of the AD assay, but will have access to standard of care tools during both rounds of case administration.
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| Alzheimer's disease assay results | Other | Within each of their virtual patient cases in Round 2 of case administration, Intervention participants will receive Alzheimer's disease assay results at the clinically appropriate point for each case. |
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| Up to 12 months |
| Difference in QURE virtual patient case scores by case type | Difference in the overall quality scores between control and intervention participants. The overall score is calculated as the percent of correct (evidence-based) minus incorrect (low-value) decisions divided by the total number of correct decisions in a QURE virtual patient case. Differences in scores between case types across rounds will be assessed to determine which use cases show the most improvement. | Up to 12 months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |