Chronic Kidney Disease(CKD), Type 2 Diabetes Mellitus (T2DM), Type 2 DM
Conditions
Keywords
CKD, T2DM, T2D, Type 2 Diabetes, Chronic kidney disease
Brief summary
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): 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.
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.
Sponsors
Duke University
Bayer
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CKD GDMT Opportunity Score at 6 months | 6 months | Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CKD GDMT Opportunity Score at 6 months weighted by dose | 6 months | Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT. |
| CKD GDMT Opportunity Score at 3 months | 3 months | Opportunity score of GDMT prescriptions at 3 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT. |
Countries
United States
Contacts
CONTACTGretchen Sanders, MSN
CONTACTMonica Leyva, MS
PRINCIPAL_INVESTIGATORNeha Pagidipati, MD
Duke University
Outcome results
None listed