实施计划，以改善糖尿病中CKD的筛查和管理（IRIS-CKD）（程序2） (IRIS-CKD)
实施计划，以改善糖尿病中CKD的筛查和管理（程序2）（IRIS-CKD）
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Gretchen Sanders, MSN
- 电话号码：919 6687829
- 邮箱：gretchen.sanders@duke.edu
研究联系人备份
- 姓名：lisa monk, MSN
- 邮箱：lisa.monk@duke.edu
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35233
- 招聘中
- University of Alabama
-
首席研究员：
- Clare Lyas, MD
-
接触：
- Sarah Machado
- 电话号码：205-934-7649
- 邮箱：smachado@uabmc.edu
-
-
Florida
-
St. Petersburg、Florida、美国、33701
- 招聘中
- Orlando Health
-
首席研究员：
- Timothy Marsh, DO
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- 招聘中
- University of Michigan
-
接触：
- Angie Westover
- 电话号码：734-936-6467
- 邮箱：funke@med.umich.edu
-
首席研究员：
- Ilka Decker, MD
-
-
Minnesota
-
Duluth、Minnesota、美国、55805
- 招聘中
- Essentia Institute of Rural Health
-
首席研究员：
- Sreedhar Devathi, MD
-
接触：
- Haley Messenger
- 电话号码：218.786.2077
- 邮箱：haley.messenger@essentiahealth.org
-
-
North Carolina
-
Durham、North Carolina、美国、27707
- 招聘中
- Duke University
-
首席研究员：
- John Middleton, MD
-
接触：
- Kim Cicio
- 邮箱：kimberly.cicio@duke.edu
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- Houston Methodist
-
首席研究员：
- Peter Nguyen
-
接触：
- Daphne Medina
- 电话号码：713-744-2016
- 邮箱：damedina2@houstonmethodist.org
-
接触：
- Steven Puckett
- 邮箱：srpuckitt@houstonmethodist.org
-
Temple、Texas、美国、76508
- 招聘中
- Baylor Scott & White
-
首席研究员：
- Tariq Tariq, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
(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.).
-
Exclusion Criteria:
-
(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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：(IRIS-CKD Management Program): Education
Education: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider. |
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. |
|
有源比较器：(IRIS-CKD Management Program): GDMT
Management: Participants will receive targeted educational materials, along with GDMT prescription, dose titration, and laboratory monitoring by a pharmacist/APP, as necessary, with guidance from a centralized algorithm and oversight from a nephrologist site PI. |
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. 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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CKD GDMT Opportunity Score at 6 months
大体时间：6 months
|
Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT. |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CKD GDMT Opportunity Score at 6 months weighted by dose
大体时间：6 months
|
Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT. |
6 months
|
|
CKD GDMT Opportunity Score at 3 months
大体时间：3 months
|
Opportunity score of GDMT prescriptions at 3 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT. |
3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
UACR change
大体时间：6 months
|
Change in UACR after 6 months |
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.