Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

Официальное название

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

Обзор

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

Подробное описание

IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.

Вмешательства

• Другое (IRIS-CKD Screening Program): Home Kit
  All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results. Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.
• Другое (IRIS-CKD Screening Program): Standard Lab Order
  ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab

Первичные конечные точки

• CKD Screening Lab Opportunity Score [Срок оценки: 3 months]

Вторичные конечные точки (1)

• CKD Screening Lab Opportunity Score by Subgroup [Срок оценки: 3 months]

Критерии участия

Screening Program-

Критерии включения

• Adults with type 2 diabetes (T2D)
• Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP).
• Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR

Критерии исключения

• Chronic kidney disease (CKD) diagnosis

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 Health — Duluth
• Duke University — Durham
• Houston Methodist — Houston
• Baylor Scott & White — Temple

Идентификаторы

NCT: NCT06906627 · Pro00116493

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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