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Clinical Trials/NCT05781334
NCT05781334
Recruiting
Not Applicable

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

Duke University1 site in 1 country200 target enrollmentJune 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Duke University
Enrollment
200
Locations
1
Primary Endpoint
Proportion of patients prescribed SGLT2i (sodium glucose co-transporter-2 inhibitors)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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/1.73m
  • 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)

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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