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

Purpose

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.

Conditions

  • Chronic Kidney Disease(CKD)
  • Type 2 DM
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
(IRIS-CKD Screening Program): Home Kit 		Home Kit: a kit delivered to participants home 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): 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.
Active Comparator
(IRIS-CKD Screening Program): Standard Lab Testing 		Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR 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

Recruiting Locations

University of Alabama
Birmingham 4049979, Alabama 4829764 35233
Contact:
Sarah Machado
smachado@uabmc.edu

More Details

Status
Recruiting
Sponsor
Duke University

Study Contact

Gretchen Sanders, MSN
919 6687829
gretchen.sanders@duke.edu

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.