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 an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
Detailed description
IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.
Interventions
OTHER(IRIS-CKD Screening Program): Home Kit
All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results. Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.
OTHER(IRIS-CKD Screening Program): Standard Lab Order
ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab
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 Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Screening Program- Inclusion Criteria: * Adults with type 2 diabetes (T2D) * Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP). * Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR
Exclusion criteria
• Chronic kidney disease (CKD) diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CKD Screening Lab Opportunity Score | 3 months | Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months. The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CKD Screening Lab Opportunity Score by Subgroup | 3 months | Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both. |
Countries
United States
Contacts
CONTACTGretchen Sanders, MSN
CONTACTMonica Leyva, MS
PRINCIPAL_INVESTIGATORNeha Pagidipati, MD
Duke University
Outcome results
None listed