Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease (PROMPT-CKD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Best practice alert and order set for CKD

Detailed Description

PROMPT-CKD is a single-system, cluster-randomized clinical trial to evaluate the effectiveness of a tailored, user-centered, clinical decision support (CDS) tool for the prescription of guideline-directed medical therapy (GDMT) in patients with Chronic Kidney Disease (CKD). Consented providers (physicians, DOs, PA, APRNs, and PharmDs within internal medicine, family medicine and nephrology departments) will be randomized to either an intervention group that will be exposed to the CDS tool, or to a control (usual care) group that will not be exposed to the CDS tool. Upon opening of the order entry screen in the patient's medical record, the CDS tool will automatically and immediately evaluate inclusion and exclusion criteria for the patient, and if all criteria are met, the patient will be automatically enrolled into the study under the randomization group of the provider who opened the chart.

The CDS tool is a best practice alert that appears for each eligible patient with CKD at the level of the order entry screen in the patient's medical record. The alert informs the provider of the presence of CKD, details the patient's most current relevant lab values, and lists current GDMT prescribed. Additionally, the alert lists GDMT which is indicated for the patient but which is not currently prescribed. The alert will also contain an order set containing the indicated medications. Providers may choose to dismiss the alert and indicate the reason. Those in the control arm of the trial will not see alerts, however a "silent alert" will be generated that registers the patient into the study. These patients will receive care as usual.

The primary outcome will assess the proportion of patients with one or more new eligible GDMT prescriptions within 90 days of randomization. Secondary outcomes include time to Major Adverse Kidney Events (MAKE), time to all-cause mortality, time to greater than 40% reduction in eGFR, time to end stage kidney disease (ESKD), time to all-cause hospitalization, and time to worsening of CKD stage.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis P Wilson, MD MSCE; Phone Number: 203-737-1704; Email: francis.p.wilson@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure to clinical decision support tool; 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; 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.
No Intervention: Usual Care; Providers will not be exposed to the clinical decision support tool when in the medical record of an eligible patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Major Adverse Kidney Events (MAKE)	Measure of the statistical difference between study arms in the time to develop any Major Adverse Kidney Events within one year-post randomization, to include: Death OR; 40% reduction in eGFR as defined by 2 measurements at least 30 days apart OR; Development of end-stage kidney disease (ESKD) defined by ICD10 code n18.6 OR; Receipt of dialysis OR; Receipt of kidney transplant	Up to 365 days post-randomization
Time to all-cause mortality	Measure of the statistical difference between study arms in the time to death from any cause within one year-post randomization.	Up to 365 days post-randomization
Time to reduction in estimated glomerular filtration rate (eGFR)	Measure of the statistical difference between study arms in the time to achieve reduction of eGFR by greater than 40% within one year-post randomization.	Up to 365 days post-randomization
Time to end-stage kidney disease (ESKD)	Measure of the statistical difference between study arms in the time to develop ESKD within one year-post randomization.	Up to 365 days post-randomization
Time to all-cause hospitalization	Measure of the statistical difference between study arms in the time to hospitalization from any cause within one year-post randomization.	Up to 365 days post-randomization
Time to CKD progression	Measure of the statistical difference between study arms in the time to worsening of CKD stage, either by eGFR criteria, or by albuminuria criteria within one year-post randomization: eGFR criteria (with a higher stage indicating worsening disease): Stage 1: eGFR of 90 or higher Stage 2: eGFR of 60-89 Stage 3: eGFR of 30-59 Stage 4: eGFR of 15-29 Stage 5: eGFR of less than 15; Albuminuria criteria (based on urine protein levels), with higher stages indicating worsening disease: A1: <30 mg/g or <3mg/mmol; A2: 30-300 mg/g or 3-30 mg/mmol; A3: >300 mg/g or >30 mg/mmol.	Up to 365 days post-randomization
Time to new GDMT prescription	Measure of the statistical difference between study arms in the time to at least one new GDMT prescription for CKD within 90 days post-randomization.	Up to 90 days post-randomization

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Francis P Wilson, MD MSCE, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2000040989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data for the primary and secondary outcomes will be made available.
• IPD Sharing Time Frame: Upon publication; indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No