Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Official title

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)

Overview

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.

Detailed description

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.

Interventions

• Other (IRIS-CKD Management Program): Education
  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.
• Other (IRIS-CKD Management Program): GDMT
  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.

Primary outcome measures

• CKD GDMT Opportunity Score at 6 months [Time frame: 6 months]

Secondary outcome measures (2)

• CKD GDMT Opportunity Score at 6 months weighted by dose [Time frame: 6 months]
• CKD GDMT Opportunity Score at 3 months [Time frame: 3 months]

Eligibility criteria

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

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

Identifiers

NCT: NCT06906640 · Pro00116493_1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗