Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease - Clinical Trial for Heart Failure | NCT05781334

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Consult Intervention

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. 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)

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Virtual Consult Intervention

Usual Care

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05781334

First Posted

February 16, 2023

Last Updated

September 1, 2023

Sponsor

Duke University

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT05781334

Brief Title

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

Acronym

IMPLEMENT-CRM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 9, 2023 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Type 2 Diabetes, Chronic Kidney Diseases

Keywords

heart failure, type 2 diabetes, chronic kidney disease, implementation, hospitalization

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual Consult Intervention

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Usual care

Intervention Type

Other

Intervention Name(s)

Virtual Consult Intervention

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

hospital discharge (up to approximately 14 days)

Title

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

Time Frame

30 days post-discharge (approximately 6 weeks)

Other Pre-specified Outcome Measures:

Title

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

Time Frame