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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Regeneron Pharmaceuticals | INDUSTRY |
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The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.
Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Cohort | Prospective patients presenting to sites after implementation of the digital health tool. | ||
| Control Cohort | Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool | ||
| Exploratory Cohort | Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort. | From time of exacerbation to 30 days after discharge |
| To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with a respiratory specialist follow-up visit within 90 days after discharge in the experimental cohort compared to the control cohort. | Enrollment to 90 days after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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Target of five geographically dispersed U.S. hospital systems to capture a diverse patient population and COPD clinical workflow.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Lutheran General Hospital | Not yet recruiting | Park Ridge | Illinois | 60068 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation. | Proportion of patients with all-cause readmission within 30 days after discharge in the experimental cohort compared to the control cohort. | Enrollment to 30 days after discharge |
| To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation. | Proportion of patients with all-cause readmission within 90 days after discharge in the experimental cohort compared to the control cohort. | Enrollment to 90 days after discharge |
| To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 30 days after discharge in the experimental cohort compared to the control cohort | Enrollment to 30 days after discharge |
| To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 90 days after discharge in the experimental cohort compared to the control cohort | Enrollment to 90 days post discharge |
| To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Rate of acute exacerbations (moderate, moderate and severe, severe) at 1 year after discharge in the experimental cohort compared to the control cohort. | Enrollment to 1 year post discharge |
| To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 30 days after discharge in the experimental cohort compared to the control cohort | Enrollment through 30 days after discharge |
| To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 90 days after discharge inthe experimental cohort compared to the control cohort. | Enrollment through 90 days after discharge |
| To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year | Rate of a composite outcome consisting of emergency department visits, readmissions, or exacerbations at 1 year after discharge in the experimental cohort compared to the control cohort. | Enrollment through 1 year after discharge |
| To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days | Proportion of patients with a cardiovascular event within 30 days after discharge in the experimental cohort compared to the control cohort. | Enrollment through 30 days after discharge |
| To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year | Rate of cardiovascular events at 1 year after discharge in the experimental cohort compared to the control cohort. | Enrollment through 1 year after discharge |
| To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days | Proportion of patients with allcause mortality within 30 days after discharge in the experimental cohort compared to the control cohort | Enrollment through 30 days after discharge |
| To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | Proportion of patients with allcause mortality within 90 days after discharge in the experimental cohort compared to the control cohort. | Enrollment through 90 days after discharge |
| To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year. | Rate of all-cause mortality at 1 year after discharge in the experimental cohort compared to the control cohort. | Enrollment through 1 year after discharge |
| To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. | The proportion of patients in the experimental cohort with pharmacological treatment consistent with the GOLD treatment recommendations at 30 and 90 days after discharge for the index exacerbation compared to the control cohort. | Enrollment through 90 days |
| Cooper University Health Care | Recruiting | Cherry Hill | New Jersey | 08002 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Aurora St. Luke's Medical Center | Not yet recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |