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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Chronic Kidney Diseases; Heart Failure
• Interventions: Other: Virtual Consult Intervention

• Registration Number: NCT05781334
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-23
• Study Start: 2023-06-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:

2. HF (any ejection fraction)

3. CKD with estimated GFR ≥ 20 mL/min/1.73m2 *

4. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Consult Intervention	Virtual 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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)	30 days post-discharge (approximately 6 weeks)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States