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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06906627
• Lead Sponsor: Duke University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-07-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CKD Screening Lab Opportunity Score	3 months	Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months.; The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline.

Secondary Outcome Measures

Name	Time	Method
CKD Screening Lab Opportunity Score by Subgroup	3 months	Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both.

Trial Locations

Locations (6)

Ochsner; 🇺🇸 New Orleans, Louisiana, United States

Essentia Health; 🇺🇸 Duluth, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott & White; 🇺🇸 Temple, Texas, United States

Intermountain Health; 🇺🇸 Murray, Utah, United States