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NCT07605390
RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
Conditions: Chronic Kidney Disease, Type 2 Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 600
Sponsor: Baylor Research Institute
Location: Baylor Scott and White Health Dallas Texas
Summary
The goal of this pragmatic randomized clinical trial is to determine whether an Epic-based clinician notification increases initiation of guideline-directed cardio-kidney-metabolic (CKM) therapies in adults with type 2 diabetes and confirmed albuminuria.
The main question it aims to answer is:
• Does an Epic clinician notification improve initiation of guideline-directed CKM therapies compared with usual care?
Researchers will compare an Epic in-basket clinician notification strategy with usual care.
In the intervention arm, the treating clinician will receive an Epic notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing electronic health record (EHR) data. Participants in the usual care arm will receive standard clinical care without notification.
Eligibility Criteria
Inclusion Criteria
* Adults aged ≥18 years
* Diagnosis of type 2 diabetes mellitus
* Receiving outpatient care within Baylor Scott \& White Health
* At least 1 outpatient encounter within the preceding 12 months
* Confirmed albuminuria (UACR \>30 mg/g)
* Eligible for one or more guideline-directed CKM therapies based on - prespecified clinical criteria and EHR review
Exclusion Criteria:
* Type 1 diabetes mellitus
* Contraindication or documented intolerance to all eligible guideline-directed CKM therapies
* Advanced kidney dysfunction below recommended initiation thresholds for SGLT2i or finerenone
* Hyperkalemia or elevated baseline serum potassium precluding safe therapy initiation
* Contraindicated drug interactions (e.g., strong CYP3A inhibitors with finerenone)
* Other guideline- or labeling-based contraindications to therapy initiation
Source: ClinicalTrials.gov (NCT07605390). StuddyBuddy aggregates publicly available trial information.