Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)
Duke University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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) ther…
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.
Locations (6)
- University of AlabamaBirmingham, Alabama
- Orlando HealthSt. Petersburg, Florida
- University of MichiganAnn Arbor, Michigan
- Essentia Institute of Rural HealthDuluth, Minnesota
- Duke UniversityDurham, North Carolina
- Baylor Scott & WhiteTemple, Texas