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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (IRIS-CKD Management Program): Education | Active Comparator | 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. |
|
| (IRIS-CKD Management Program): GDMT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (IRIS-CKD Management Program): Education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CKD 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| CKD GDMT Opportunity Score at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| UACR change | Change in UACR after 6 months | 6 months |
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):
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Sanders, MSN | Contact | 919 6687829 | gretchen.sanders@duke.edu | |
| Monica Leyva, MS | Contact | monica.leyva@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neha Pagidipati, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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(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.
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|
| (IRIS-CKD Management Program): GDMT | Other | 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. |
|
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.
| 3 months |
| Orlando Health | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Essentia Institute of Rural Health | Recruiting | Duluth | Minnesota | 55805 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27707 | United States |
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| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
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| Baylor Scott & White | Recruiting | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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