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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Kidney Diseases; Type 2 Diabetes
• Intervention / Treatment: Other: Virtual Consult Intervention

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Number of participants with Mineralocorticoid receptor antagonist for heart failure	hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
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)
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)
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)
Number of participants with all-cause hospital readmission	30 days post-discharge (approximately 6 weeks)
Number of participants with heart failure readmission	30 days post-discharge (approximately 6 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Stephen J Greene, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; heart failure; type 2 diabetes; hospitalization; implementation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic; Metabolic Diseases
• Other Study ID Numbers: Pro00112465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No