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NOT YET RECRUITING

NCT07430930

Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-03

Completion Date

2028-03

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Chronic Kidney Diseases

Interventions

OTHER

Best practice alert and order set for CKD

Providers are exposed to a best practice alert upon opening of the order entry screen in a patient's medical record. The alert informs the provider of the presence of CKD, details the patient's current relevant labs and medications, and provides a list of recommended indicated GDMT for CKD which the patient is currently not prescribed. The alert includes an order set with all indicated medications with additional prescribing information. The alerts additionally includes a link to updated guidelines for GDMT prescription for CKD. Providers will be given the option to dismiss the alert and to indicate reasons for dismissing.

Inclusion Criteria: 1. Male or female, aged ≥18 years 2. Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL/min/1.73m2 with an uACR ≥30 mg/g or eGFR \>90 mL/min/1.73m2 with an uACR ≥30 mg/g. 3. Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria. 4. To receive an ACEi/ARB: eGFR ≥15 ml/min/1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg/g). 5. To receive an SGLT2i: have heart failure (defined by ICD10 code); or T2D; or uACR ≥200 mg/g; or eGFR ≥20 ml/min/1.732. 6. To receive an MRA: ns-MRA: have an eGFR ≥25 ml/min/1.732, diagnosis of T2D, normal serum potassium (≤4.8 mmol/L) and albuminuria (\>30 mg/g). s-MRA: have an eGFR ≥45 ml/min/1.732 and heart failure, hyperaldosteronism, or refractory hypertension. 7. To receive a GLP-1 RA: have T2D. 8. Ability to take oral medication. Exclusion Criteria: 1. Allergy to the GDMT for which the patient is eligible 2. End-stage kidney disease 3. CKD stage 5 (eGFR \<15 ml/min/1.73m2) 4. Glomerulonephritis (by ICD-10 code) 5. Polycystic kidney disease (by ICD-10 code) 6. History of kidney transplant 7. End-stage heart failure 8. Eligible to receive ACEi/ARB but having blood pressure \<110/70 mmHg or have known renal artery stenosis 9. Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code. 10. Eligible to receive MRA but serum potassium ≥5 mmol/L, have office SBP \<100 mmHg, adrenal insufficiency based on ICD10 code or concomitant treatment with CYP3A4 inhibitors (Strong: grapefruit, grapefruit juice, itraconazole. Moderate: erythromycin. Weak: amiodarone). 11. Eligible to receive GLP-1 RA but pregnant; or found to have personal history of pancreatitis; or personal or family history of medullary thyroid cancer or MEN type 2 based on ICD10 code or gastroparesis based on ICD10 code. 12. Opted out of EHR-based research.

Locations (1)

Yale New Haven Health

New Haven, Connecticut, United States