RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)

Официальное название

RAPID-CKM: RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Epic-Based Clinician Notification
  Epic in-basket clinician notification identifying confirmed albuminuria and potential eligibility for guideline-directed CKM therapies using existing EHR data.
• Другое Usual Care
  Standard clinical care without Epic clinician notification.

Первичные конечные точки

• Initiation of Guideline-Directed Cardio-Kidney Metabolic Therapy [Срок оценки: 3 months]
• Therapy-Specific Initiation Rate [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Time to Guideline-Directed Therapy Initiation [Срок оценки: 3 months]
• Repeat Epic Notification Frequency [Срок оценки: 30 days]
• Clinician Reach [Срок оценки: 3 months]
• Clinician Response to Epic Notification [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Baylor Scott and White Health — Dallas
• Baylor Scott and White, Advanced Heart Care — Plano

Идентификаторы

NCT: NCT07605390 · 026-355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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