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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
420
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.
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.
University of Alabama
Birmingham, Alabama, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGEssentia Institute of Rural Health
Duluth, Minnesota, United States
RECRUITINGCKD GDMT Opportunity Score at 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.
Time frame: 6 months
CKD GDMT Opportunity Score at 6 months weighted by dose
Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.
Time frame: 6 months
CKD GDMT Opportunity Score at 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.
Time frame: 3 months
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Duke University
Durham, North Carolina, United States
RECRUITING