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

NCT07430930 | Not Yet Recruiting

• 1 other identifier: 2000040989
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• New GDMT prescription within 90 days

  Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization.

  Up to 90 days of randomization

Secondary Outcomes (7)

• Time to Major Adverse Kidney Events (MAKE)

  Up to 365 days post-randomization

• Time to all-cause mortality

  Up to 365 days post-randomization

• Time to reduction in estimated glomerular filtration rate (eGFR)

  Up to 365 days post-randomization

• Time to end-stage kidney disease (ESKD)

  Up to 365 days post-randomization

• Time to all-cause hospitalization

  Up to 365 days post-randomization

Study Arms (2)

Exposure to clinical decision support tool

EXPERIMENTAL

Providers will see a best practice alert with an attached order set upon opening the order entry screen in an eligible patient's medical record.

Other: Best practice alert and order set for CKD

Usual Care

NO INTERVENTION

Providers will not be exposed to the clinical decision support tool when in the medical record of an eligible patient.

Interventions

Best practice alert and order set for CKD OTHER

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.

Exposure to clinical decision support tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years
• 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.
• Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria.
• 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).
• 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.
• 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.
• To receive a GLP-1 RA: have T2D.
• Ability to take oral medication.

You may not qualify if:

• Allergy to the GDMT for which the patient is eligible
• End-stage kidney disease
• CKD stage 5 (eGFR \<15 ml/min/1.73m2)
• Glomerulonephritis (by ICD-10 code)
• Polycystic kidney disease (by ICD-10 code)
• History of kidney transplant
• End-stage heart failure
• Eligible to receive ACEi/ARB but having blood pressure \<110/70 mmHg or have known renal artery stenosis
• Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code.
• 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).
• 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.
• Opted out of EHR-based research.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis P Wilson, MD MSCE

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis P Wilson, MD MSCE

CONTACT

203-737-1704; francis.p.wilson@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient participants will be blinded to randomization group, however provider participants will not be blinded as they are receiving alerts in the electronic medical record as part of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication; indefinitely.

Locations

US (1)