Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease

Study Overview
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Brief Summary
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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.

Official Title
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Identifying Barriers to and optiMizing In-hosPitaL usE of Evidenced-based Medical thErapies for patieNTs With Cardio-Renal-Metabolic Disease

Conditions
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Heart Failure, Type 2 Diabetes, Chronic Kidney Diseases

Intervention / Treatment
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* Other: Virtual Consult Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record: HF (any ejection fraction) CKD with estimated GFR ≥ 20 mL/min/1.73m2 * T2DM (by clinical history or hemoglobin A1c) Exclusion Criteria: End-stage stage renal disease on dialysis or eGFR <20 mL/kg/1.73m2. Pre-menopausal woman who are either breast-feeding or pregnant History of heart transplant or actively listed for heart transplant Implanted left ventricular assist device or implant anticipated within 3 months. Enrolled in or planning to enroll in hospice care. Active cancer (except localized prostate, breast, or non-melanoma skin cancers)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual Consult Intervention<br>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. | Other: Virtual Consult Intervention<br>* 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<br>|
| No Intervention: Usual Care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization