Chronic Kidney DiseasesPROMPT-CKDNCT07430930
Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease
A study testing Best practice alert and order set for CKD in people with Chronic Kidney Diseases, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Best practice alert and order set for CKD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Best practice alert and order set for CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice alert and order set for CKDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New GDMT prescription within 90 days
Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization.
Measured: Up to 90 days of randomization
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim International GmbH
- Responsible party
- Sponsor
- Investigators
- Francis P Wilson, MD MSCE, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430930
- Sponsor's protocol ID
- 2000040989
- Acronym
- PROMPT-CKD
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for the primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07430930
- Acronym / sponsor ID
- PROMPT-CKD / 2000040989
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim International GmbH
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure to clinical decision support tool | Experimental | Other: Best practice alert and order set for CKDProviders will see a best practice alert with an attached order set upon opening the order entry screen in an eligible patient's medical record. |
| Usual Care | No intervention | –Providers will not be exposed to the clinical decision support tool when in the medical record of an eligible patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best practice alert and order set for CKDProviders 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. | Other | Exposure to clinical decision support tool |
Primary outcome
New GDMT prescription within 90 days
Time frame: Up to 90 days of randomization
Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization.
7 secondary outcomes
Time to Major Adverse Kidney Events (MAKE)
Time frame: Up to 365 days post-randomization
Time to all-cause mortality
Time frame: Up to 365 days post-randomization
Time to reduction in estimated glomerular filtration rate (eGFR)
Time frame: Up to 365 days post-randomization
Time to end-stage kidney disease (ESKD)
Time frame: Up to 365 days post-randomization
Time to all-cause hospitalization
Time frame: Up to 365 days post-randomization
Time to CKD progression
Time frame: Up to 365 days post-randomization
Time to new GDMT prescription
Time frame: Up to 90 days post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data for the primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis P Wilson, MD MSCE principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best practice alert and order set for CKD in people with Chronic Kidney Diseases, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francis P Wilson, MD MSCE (203-737-1704, francis.p.wilson@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New GDMT prescription within 90 days (time frame: Up to 90 days of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.