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

NCT05781334 | Completed

• 1 other identifier: Pro00112465
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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

Keywords

heart failure; type 2 diabetes; chronic kidney disease; implementation; hospitalization

Outcome Measures

Primary Outcomes (2)

• Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)

  hospital discharge (up to approximately 14 days)

• Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)

  30 days post-discharge (approximately 6 weeks)

Other Outcomes (9)

• 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)

• 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)

Study Arms (2)

Virtual Consult Intervention

ACTIVE COMPARATOR

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.

Other: Virtual Consult Intervention

Usual Care

NO INTERVENTION

Usual care

Interventions

Virtual Consult Intervention 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

Virtual Consult Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:
• HF (any ejection fraction)
• CKD with estimated GFR ≥ 20 mL/min/1.73m2 \*
• T2DM (by clinical history or hemoglobin A1c)

You may not qualify if:

• End-stage stage renal disease on dialysis or eGFR \<20 mL/kg/1.73m2.
• Pre-menopausal woman who are either breast-feeding or pregnant
• History of heart transplant or actively listed for heart transplant
• Implanted left ventricular assist device or implant anticipated within 3 months.
• Enrolled in or planning to enroll in hospice care.
• Active cancer (except localized prostate, breast, or non-melanoma skin cancers)

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen J Greene

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 23, 2023
• Study Start: June 9, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)