Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

ConditionsChronic Kidney Disease(CKD)Type 2 DM Type 2 Diabetes Mellitus (T2DM)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

(IRIS-CKD Screening Program): Home Kit
Other intervention
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.
(IRIS-CKD Screening Program): Standard Lab Order
Other intervention
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

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: (IRIS-CKD Screening Program): Home KitActive comparator 1 intervention

Group B: (IRIS-CKD Screening Program): Standard Lab TestingActive comparator 1 intervention

Trial outcomes

Primary outcomes

CKD Screening Lab Opportunity Score

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.

Time frame

3 months

Secondary outcomes

CKD Screening Lab Opportunity Score by Subgroup

Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Bayer

Collaborator

Boehringer Ingelheim