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NCT Number: NCT07605390

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epic-Based Clinician Notification

Other

Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.

Usual Care

Other

Standard clinical care without Epic clinician notification.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shahzeb Khan, MD

CONTACT

[email protected]

469-326-2636

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 26, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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