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

May 19, 2026 updated by: Baylor Research Institute

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:

• 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
      • Plano, Texas, United States, 75093
        • Baylor Scott and White, Advanced Heart Care
        • Contact:
        • Principal Investigator:
          • Shahzeb Khan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epic Clinician Notification
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.
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.
Active Comparator: Usual Care
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.
Other: Usual Care
Standard clinical care without Epic clinician notification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
30 days
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.
3 months
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Shahzeb Khan, MD, Baylor Scott and White Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26RIRA1643959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available following publication of the primary study results and will remain available for at least 5 years after publication.

IPD Sharing Access Criteria

Access will be provided to qualified researchers upon reasonable request following review and approval by the study investigators and Baylor Scott & White Research Institute. Shared data will be deidentified and made available in accordance with institutional policies, applicable regulations, and data use agreements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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