Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Официальное название

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)

Обзор

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Подробное описание

IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.

Вмешательства

• Другое (IRIS-CKD Management Program): Education
  Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.
• Другое (IRIS-CKD Management Program): GDMT
  Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.

Первичные конечные точки

• CKD GDMT Opportunity Score at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (2)

• CKD GDMT Opportunity Score at 6 months weighted by dose [Срок оценки: 6 months]
• CKD GDMT Opportunity Score at 3 months [Срок оценки: 3 months]

Критерии участия

Критерии включения

• (CKD Management)

• Adults with type 2 diabetes (T2D)
• Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
• Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):

• UACR >300 mg/g or
• eGFR <45 ml/min/1.73 m2 or
• UACR ≥30 mg/g with eGFR <60 ml/min/1.73 m2
• Receiving <100% GDMT at baseline. For patients with UACR <30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).

Критерии исключения

• (CKD Management)

• Type 1 diabetes
• Most recent eGFR <20 ml/min/1.73 m2
• Prior kidney transplant
• Autosomal dominant polycystic kidney disease (ADPKD)
• Active pregnancy or plans for conception within 1 year

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

Другое

Центры проведения

США · 7 центров

• University of Alabama — Birmingham
• Orlando Health — St. Petersburg
• University of Michigan — Ann Arbor
• Essentia Institute of Rural Health — Duluth
• Duke University — Durham
• Houston Methodist — Houston
• Baylor Scott & White — Temple

Идентификаторы

NCT: NCT06906640 · Pro00116493_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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