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

NCT ID: NCT05781334

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2024-08-31

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.

Conditions

Heart Failure; Type 2 Diabetes; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Virtual Consult Intervention

Intervention Type: OTHER

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

Usual Care

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Greene

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00112465

Identifier Type: -

Identifier Source: org_study_id