Chronic Kidney DiseaseNCT07605390
RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
A study testing Epic-Based Clinician Notification in people with Chronic Kidney Disease and Type 2 Diabetes, run by Baylor Research Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- Epic-Based Clinician Notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2026to Jan 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Baylor Scott and White Health
Dallas, Texas, 75246
Baylor Scott and White, Advanced Heart Care
Plano, Texas, 75093
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- Epic-Based Clinician Notification, Usual Care
- Keywords
- Cardio-Kidney-Metabolic Syndrome, Albuminuria, Urine Albumin-to-Creatinine Ratio, Guideline-Directed Medical Therapy, Electronic Health Record, Epic, Implementation Science, Pragmatic Trial, Renin-Angiotensin System Inhibitors, Sodium-Glucose Cotransporter-2 Inhibitors, Glucagon-Like Peptide-1 Receptor Agonists, Non-steroidal Mineralocorticoid Receptor Antagonists, Finerenone, CKM Care, Type 2 Diabetes, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epic-Based Clinician NotificationOther
Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.
Usual CareOther
Standard clinical care without Epic clinician notification.
| Study group | Role | What they receive |
|---|---|---|
| Epic Clinician Notification | Experimental | Treating clinicians receive an Epic in-basket notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. All treatment decisions remain at the discretion of the treating clinician. Receives: Other: Epic-Based Clinician Notification |
| Usual Care | Active comparator | Participants receive standard clinical care without Epic clinician notification. Treatment decisions, including initiation of guideline-directed CKM therapies, remain at the discretion of the treating clinician. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy
Proportion of eligible participants newly prescribed one or more guideline-directed cardio-kidney-metabolic (CKM) therapies, including renin-angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), non-steroidal mineralocorticoid receptor antagonists (ns-MRA), or glucagon-like peptide-1 receptor agonists (GLP-1RA) as assessed using electronic health record (EHR) data.
Measured: 3 months
Therapy-Specific Initiation Rate
Proportion of participants eligible for a specific CKM therapy who were newly prescribed each individual guideline-directed CKM therapy class (RASi, SGLT2i, ns-MRA, or GLP-1RA), as assessed using electronic health record (EHR) data.
Measured: 3 months
Secondary outcomes (4)
Time to Guideline-Directed Therapy Initiation
Time from randomization to initiation of one or more eligible guideline-directed CKM therapies, assessed using electronic health record (EHR) prescribing data.
Measured: 3 months
Repeat Epic Notification Frequency
Proportion of participants requiring repeat Epic clinician notification due to absence of documented therapy initiation or clinician response within 30 days of the initial notification, as assessed using electronic health record (EHR) data.
Measured: 30 days
Clinician Reach
Proportion of eligible clinicians who received Epic-based CKM notifications, as assessed using electronic health record (EHR) notification metadata.
Measured: 3 months
Clinician Response to Epic Notification
Proportion of Epic clinician notifications associated with documented clinician acknowledgment, therapy initiation, or therapy deferral, as assessed using electronic health record (EHR) data.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start6 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 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 DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahzeb Khan, MD, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605390
- Sponsor's protocol ID
- 026-355
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the reported study results will be shared, including demographic, clinical, laboratory, prescribing, and implementation-related variables collected through the electronic health record (EHR). A data dictionary and analytic code may also be shared to support interpretation and reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.
- ClinicalTrials.gov ID
- NCT07605390
- Acronym / sponsor ID
- 026-355
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Keywords
- Cardio-Kidney-Metabolic Syndrome, Albuminuria, Urine Albumin-to-Creatinine Ratio, Guideline-Directed Medical Therapy, Electronic Health Record, Epic, Implementation Science, Pragmatic Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 May 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epic Clinician Notification | Experimental | Other: Epic-Based Clinician NotificationTreating clinicians receive an Epic in-basket notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. All treatment decisions remain at the discretion of the treating clinician. |
| Usual Care | Active comparator | Other: Usual CareParticipants receive standard clinical care without Epic clinician notification. Treatment decisions, including initiation of guideline-directed CKM therapies, remain at the discretion of the treating clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Epic-Based Clinician NotificationEpic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. | Other | Epic Clinician Notification |
| Usual CareStandard clinical care without Epic clinician notification. | Other | Usual Care |
Primary outcome
Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy
Time frame: 3 months
Proportion of eligible participants newly prescribed one or more guideline-directed cardio-kidney-metabolic (CKM) therapies, including renin-angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), non-steroidal mineralocorticoid receptor antagonists (ns-MRA), or glucagon-like peptide-1 receptor agonists (GLP-1RA) as assessed using electronic health record (EHR) data.
Therapy-Specific Initiation Rate
Time frame: 3 months
Proportion of participants eligible for a specific CKM therapy who were newly prescribed each individual guideline-directed CKM therapy class (RASi, SGLT2i, ns-MRA, or GLP-1RA), as assessed using electronic health record (EHR) data.
4 secondary outcomes
Time to Guideline-Directed Therapy Initiation
Time frame: 3 months
Repeat Epic Notification Frequency
Time frame: 30 days
Clinician Reach
Time frame: 3 months
Clinician Response to Epic Notification
Time frame: 30 days
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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the reported study results will be shared, including demographic, clinical, laboratory, prescribing, and implementation-related variables collected through the electronic health record (EHR). A data dictionary and analytic code may also be shared to support interpretation and reproducibility.
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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.
Shahzeb Khan, MD principal investigator
Baylor Scott and White Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epic-Based Clinician Notification in people with Chronic Kidney Disease and Type 2 Diabetes, run by Baylor Research Institute at 2 sites 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy (time frame: 3 months). The study lists 2 primary outcomes in all. 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 15 Oct 2026.