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

January 9, 2024 updated by: Duke University

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: hospital discharge (up to approximately 14 days)
hospital discharge (up to approximately 14 days)
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Time Frame: 30 days post-discharge (approximately 6 weeks)
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
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Number of participants with ARNI for heart failure
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
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%
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
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)
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
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
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
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
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).
Time Frame: hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
hospital discharge (up to approximately 14 days), 30 days post-discharge (approximately 6 weeks)
Number of participants with all-cause hospital readmission
Time Frame: 30 days post-discharge (approximately 6 weeks)
30 days post-discharge (approximately 6 weeks)
Number of participants with heart failure readmission
Time Frame: 30 days post-discharge (approximately 6 weeks)
30 days post-discharge (approximately 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Boehringer Ingelheim

Investigators

  • Principal Investigator: Stephen J Greene, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 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)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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