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

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781334

Collaborator

Boehringer Ingelheim (Industry)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Type 2 Diabetes Chronic Kidney Diseases	Other: Virtual Consult Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Usual Care Usual care

Arm

Intervention/Treatment

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

No Intervention: Usual Care

Usual care

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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)