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NCT Number: NCT05781334

Optimizing In-hospital Use of Evidence-based 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27707, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

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

    Time frame: hospital discharge (up to approximately 14 days)

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

    Time frame: 30 days post-discharge (approximately 6 weeks)

Other outcomes

  1. Number of participants with ACEI/ARB therapy among patients with heart failure or chronic kidney disease

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  2. Number of participants with ARNI for heart failure

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  3. Number of participants with Beta-blocker therapy for heart failure with ejection fraction <50%

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  4. Number of participants with Mineralocorticoid receptor antagonist for heart failure

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  5. Number of participants with GLP-1 receptor agonist for type 2 diabetes

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  6. Number of participants with GLP-1 receptor agonist and/or SGLT2i for type 2 diabetes

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  7. 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).

    Time frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)

  8. Number of participants with all-cause hospital readmission

    Time frame: 30 days post-discharge (approximately 6 weeks)

  9. Number of participants with heart failure readmission

    Time frame: 30 days post-discharge (approximately 6 weeks)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Acronym: IMPLEMENT-CRM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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