Current partner codePEPTIDESDE
NCT07605390·Not applicable·INTERVENTIONAL

RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)

Status

Not yet recruiting

Phase

Not applicable

Enrollment

600

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    May 26, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Jan 2028

  4. Study completion

    Jan 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Time to Guideline-Directed Therapy Initiation

Time frame · 3 months

Time from randomization to initiation of one or more eligible guideline-directed CKM therapies, assessed using electronic health record (EHR) prescribing data.

Repeat Epic Notification Frequency

Time frame · 30 days

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.

Clinician Reach

Time frame · 3 months

Proportion of eligible clinicians who received Epic-based CKM notifications, as assessed using electronic health record (EHR) notification metadata.

Clinician Response to Epic Notification

Time frame · 30 days

Proportion of Epic clinician notifications associated with documented clinician acknowledgment, therapy initiation, or therapy deferral, as assessed using electronic health record (EHR) data.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Baylor Scott and White Health

Dallas, Texas, United States

Baylor Scott and White, Advanced Heart Care

Plano, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Related PeptideStat pages

Put the record in context.

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