Chronic Kidney Disease, Type 2 Diabetes
Conditions
Keywords
Cardio-Kidney-Metabolic Syndrome, Albuminuria, Urine Albumin-to-Creatinine Ratio, Guideline-Directed Medical Therapy, Electronic Health Record, Epic, Implementation Science, Pragmatic Trial, Renin-Angiotensin System Inhibitors, Sodium-Glucose Cotransporter-2 Inhibitors, Glucagon-Like Peptide-1 Receptor Agonists, Non-steroidal Mineralocorticoid Receptor Antagonists, Finerenone, CKM Care, Type 2 Diabetes, Chronic Kidney Disease
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.
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
OTHEREpic-Based Clinician Notification
Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.
OTHERUsual Care
Standard clinical care without Epic clinician notification.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Guideline-Directed Therapy Initiation | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTShahzeb Khan, MD
PRINCIPAL_INVESTIGATORShahzeb Khan, MD
Baylor Scott and White Health
Outcome results
None listed