About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Epic-Based Clinician Notification
Other interventionEpic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.
Usual Care
Other interventionStandard clinical care without Epic clinician notification.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Time to Guideline-Directed Therapy Initiation
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
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
Proportion of eligible clinicians who received Epic-based CKM notifications, as assessed using electronic health record (EHR) notification metadata.
Clinician Response to Epic Notification
Proportion of Epic clinician notifications associated with documented clinician acknowledgment, therapy initiation, or therapy deferral, as assessed using electronic health record (EHR) data.
Sponsors and contacts
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