RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)

RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.

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.

This study is a pragmatic, randomized, EHR-embedded implementation trial designed to evaluate whether an Epic-based clinician notification improves initiation of guideline-directed CKM therapies in adults with type 2 diabetes and confirmed albuminuria.

Despite contemporary guideline recommendations, substantial gaps remain in urine albumin-to-creatinine ratio (UACR) screening, confirmatory testing, and initiation of evidence-based CKM therapies, including renin-angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), non-steroidal mineralocorticoid receptor antagonists (ns-MRA), and glucagon-like peptide-1 receptor agonists (GLP-1RA). Health-system workflows frequently fail to translate identification of albuminuria-associated CKM risk into timely initiation of disease-modifying therapy.

Eligible participants will be randomized in a 1:1 ratio to either usual care or an Epic-based clinician notification strategy.

In the intervention arm, the treating clinician will receive an Epic in-basket message identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. All treatment decisions will remain at the discretion of the treating clinician.

The primary endpoint is initiation of one or more eligible guideline-directed CKM therapies within 3 months of randomization.

This study will provide important implementation data regarding whether low-burden EHR-based clinician notifications can improve evidence-based CKM care in real-world clinical practice settings.

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