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

Heart Failure Clinical Trial

— IMPLEMENT-CRM  

Official title:

Identifying Barriers to and optiMizing In-hosPitaL usE of Evidenced-based Medical thErapies for patieNTs With Cardio-Renal-Metabolic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781334
• Other study ID #: Pro00112465
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Stephen J Greene
• Phone: 919 684 8111
• Email: stephen.green[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Heart Failure
• Kidney Diseases
• Metabolic Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Number of participants with ARNI for heart failure		hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Other	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)
Other	Number of participants with Mineralocorticoid receptor antagonist for heart failure		hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Other	Number of participants with GLP-1 receptor agonist for type 2 diabetes		hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Other	Number of participants with GLP-1 receptor agonist and/or SGLT2i for type 2 diabetes		hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Other	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).		hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Other	Number of participants with all-cause hospital readmission		30 days post-discharge (approximately 6 weeks)
Other	Number of participants with heart failure readmission		30 days post-discharge (approximately 6 weeks)
Primary	Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)		hospital discharge (up to approximately 14 days)
Primary	Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)		30 days post-discharge (approximately 6 weeks)