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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Consult Intervention | Active Comparator | The intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications. |
|
| Usual Care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Consult Intervention | Other | The intervention will consist of a quality improvement (QI)-based virtual consult designed by a multi-disciplinary team that will aim to address provider-level, patient-level, and system-level barriers to cardio-renal-metabolic disease medications |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors) | hospital discharge (up to approximately 14 days) | |
| Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors) | 30 days post-discharge (approximately 6 weeks) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ACEI/ARB therapy among patients with heart failure or chronic kidney disease | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) | |
| Number of participants with ARNI for heart failure | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
Inclusion Criteria:
1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Greene | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27707 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| Number of participants with Beta-blocker therapy for heart failure with ejection fraction <50% | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| Number of participants with Mineralocorticoid receptor antagonist for heart failure | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| Number of participants with GLP-1 receptor agonist for type 2 diabetes | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| Number of participants with GLP-1 receptor agonist and/or SGLT2i for type 2 diabetes | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| Composite medication score at discharge based on the use of ≥ 50% target dosing of ACEI/ARB/ARNI and beta-blocker, any MRA dose, and any SGLT2i dose (for patients with heart failure and ejection fraction </=40% only). | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| Number of participants with all-cause hospital readmission | 30 days post-discharge (approximately 6 weeks) |
| Number of participants with heart failure readmission | 30 days post-discharge (approximately 6 weeks) |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |