Chronic Kidney Diseases, Heart Failure, Type 2 Diabetes
Conditions
Keywords
heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization
Brief summary
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.
Interventions
OTHERVirtual Consult Intervention
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
Sponsors
Boehringer Ingelheim
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record: 1. HF (any ejection fraction) 2. CKD with estimated GFR ≥ 20 mL/min/1.73m2 \* 3. T2DM (by clinical history or hemoglobin A1c)
Exclusion criteria
1. End-stage stage renal disease on dialysis or eGFR \<20 mL/kg/1.73m2. 2. Pre-menopausal woman who are either breast-feeding or pregnant 3. History of heart transplant or actively listed for heart transplant 4. Implanted left ventricular assist device or implant anticipated within 3 months. 5. Enrolled in or planning to enroll in hospice care. 6. Active cancer (except localized prostate, breast, or non-melanoma skin cancers)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors) | hospital discharge (up to approximately 14 days) |
Other
| Measure | Time frame |
|---|---|
| Number of participants with ARNI for heart failure | hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks) |
| 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 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) |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed