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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Repeat Epic Notification Frequency |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahzeb Khan, MD | Contact | 469-326-2636 | shahzeb.khan@bswhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Shahzeb Khan, MD | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Health | Dallas | Texas | 75246 | United States |
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.
Data will become available following publication of the primary study results and will remain available for at least 5 years after publication.
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.
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| Usual Care | Other | Standard clinical care without Epic clinician notification. |
|
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 | 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 | 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 |
| Baylor Scott and White, Advanced Heart Care | Plano | Texas | 75093 | United States |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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