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

Duke University

Status: Completed

Conditions: Chronic Kidney Diseases; Type 2 Diabetes; Heart Failure

Treatments: Other: Virtual Consult Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05781334

Pro00112465

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

202 participants in 2 patient groups

Virtual Consult Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Virtual Consult Intervention

Usual Care

No Intervention group

Description:

Usual care