NCT07605390

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Aug 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Chronic Kidney DiseaseType 2 Diabetes

Keywords

Cardio-Kidney-Metabolic SyndromeAlbuminuriaUrine Albumin-to-Creatinine RatioGuideline-Directed Medical TherapyElectronic Health RecordEpicImplementation SciencePragmatic TrialRenin-Angiotensin System InhibitorsSodium-Glucose Cotransporter-2 InhibitorsGlucagon-Like Peptide-1 Receptor AgonistsNon-steroidal Mineralocorticoid Receptor AntagonistsFinerenoneCKM CareType 2 DiabetesChronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Secondary Outcomes (4)

  • Time to Guideline-Directed Therapy Initiation

    3 months

  • Repeat Epic Notification Frequency

    30 days

  • Clinician Reach

    3 months

  • Clinician Response to Epic Notification

    30 days

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Epic-Based Clinician NotificationOTHER

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

Epic Clinician Notification
Usual CareOTHER

Standard clinical care without Epic clinician notification.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor Scott and White Health

Dallas, Texas, 75246, United States

Location

Baylor Scott and White, Advanced Heart Care

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2Albuminuria

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and Symptoms

Study Officials

  • Shahzeb Khan, MD

    Baylor Scott and White Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahzeb Khan, MD

CONTACT

469-326-2636shahzeb.khan@bswhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will become available following publication of the primary study results and will remain available for at least 5 years after publication.
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.

Locations

US(2)