Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (IRIS-CKD Screening Program): Home Kit, (IRIS-CKD Screening Program): Standard Lab Order.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease(CKD), Type 2 DM, Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)
Overview
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.
Detailed description
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.
Interventions
- Other (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. - Other (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
Primary outcome measures
- CKD Screening Lab Opportunity Score [Time frame: 3 months]
Secondary outcome measures (1)
- CKD Screening Lab Opportunity Score by Subgroup [Time frame: 3 months]
Eligibility criteria
Screening Program-
Inclusion criteria
- 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
Exclusion criteria
- Chronic kidney disease (CKD) diagnosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 7 centers
- 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
Identifiers
NCT: NCT06906627 · Pro00116493