RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epic-Based Clinician Notification, Usual Care.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.
Overview
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.
Interventions
- Other Epic-Based Clinician Notification
Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data. - Other Usual Care
Standard clinical care without Epic clinician notification.
Primary outcome measures
- Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy [Time frame: 3 months]
- Therapy-Specific Initiation Rate [Time frame: 3 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Baylor Scott and White Health — Dallas
- Baylor Scott and White, Advanced Heart Care — Plano
Identifiers
NCT: NCT07605390 · 026-355