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

Duke University

Status: Not yet enrolling

Conditions: Type 2 DM; Chronic Kidney Disease(CKD); Type 2 Diabetes Mellitus (T2DM)

Treatments: Other: (IRIS-CKD Screening Program): Home Kit; Other: (IRIS-CKD Screening Program): Standard Lab Order

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06906627

Pro00116493

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

(IRIS-CKD Screening Program): Home Kit

Active Comparator group

Description:

Home Kit: a kit delivered to participants home with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.

Treatment:

Other: (IRIS-CKD Screening Program): Home Kit

(IRIS-CKD Screening Program): Standard Lab Testing

Active Comparator group

Description:

Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline.

Treatment:

Other: (IRIS-CKD Screening Program): Standard Lab Order