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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.
Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk Assessment and Intensive Prevention Strategy | Experimental | Primary care providers (PCP) randomized to the Risk Assessment and Intensive Prevention Strategy Arm will receive notification if any patients with diabetes under their care have high heart failure risk based on clinical or biomarker scores. Providers will receive recommendations, option for e-consultation, and referral to cardiometabolic risk management program. |
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| Usual Care | No Intervention | Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Prevention Strategy | Behavioral | Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident Heart Failure or All-cause death | Incident Heart Failure (based on electronic health record International Classification of Diseases codes) or all-cause death. This will be assessed via retrospective chart review. | 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Rates of SGLT2i | Counts of SGLT2 inhibitor prescriptions filled | 6-months from electronic health record alert. |
| Prescription Rate of Finerenone | Counts of Finerenone prescriptions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ambarish Pandey, MD | Contact | 617-869-8957 | ambarish.pandey@utsouthwestern.edu | |
| VINAYAK SUBRAMANIAN, MD | Contact | 2114-645-9868 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75209 | United States |
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| 6-months from electronic health record alert. |
| Prescription Rate of GLP1 | Counts of GLP1 prescription | 6-months from electronic health record alert. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D058065 | Diabetic Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
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