Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
Purpose
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.
Conditions
- Chronic Kidney Disease(CKD)
- Type 2 DM
- Type 2 Diabetes Mellitus (T2DM)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- (IRIS-CKD Management Program) is a comparative effectiveness 1:1 randomized trial of two interventions (Management vs. Education) to improve implementation of GDMT for CKD in 420 patients with T2D. All potential participants will receive educational materials on importance and opportunities to treat CKD before randomization. After randomization, both Education and Management participants will receive targeted educational materials on CKD and GDMT. The primary outcome will be an opportunity score of CKD GDMT at 6 months based on prescriptions.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator (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. |
|
|
Active Comparator (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. |
|
Recruiting Locations
University of Alabama
Birmingham 4049979, Alabama 4829764 35233
Birmingham 4049979, Alabama 4829764 35233
More Details
- Status
- Recruiting
- Sponsor
- Duke University
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.