Clinical trial NCT05781334: Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease
Official title: Identifying Barriers to and optiMizing In-hosPitaL usE of Evidenced-based Medical thErapies for patieNTs With Cardio-Renal-Metabolic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Type 2 Diabetes
Chronic Kidney Diseases
Keywords: heart failure
type 2 diabetes
chronic kidney disease
implementation
hospitalization
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2023-03-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
timeFrame: hospital discharge (up to approximately 14 days)
measure: Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
timeFrame: 30 days post-discharge (approximately 6 weeks)
Secondary outcomes:
Other outcomes:
measure: Number of participants with ACEI/ARB therapy among patients with heart failure or chronic kidney disease
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with ARNI for heart failure
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with Beta-blocker therapy for heart failure with ejection fraction <50%
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with Mineralocorticoid receptor antagonist for heart failure
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with GLP-1 receptor agonist for type 2 diabetes
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with GLP-1 receptor agonist and/or SGLT2i for type 2 diabetes
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: 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).
timeFrame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with all-cause hospital readmission
timeFrame: 30 days post-discharge (approximately 6 weeks)
measure: Number of participants with heart failure readmission
timeFrame: 30 days post-discharge (approximately 6 weeks)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Stephen J Greene
role: PRINCIPAL_INVESTIGATOR
References: