RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Usual Care (Other)
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.
干预措施: Epic-Based Clinician Notification (Other)