Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus

NCT05342545 | Completed

• 1 other identifier: 2022P000778
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

While data from the National Health and Nutrition Examination Survey (NHANES) estimate that 36.9% of patients with diabetes have CKD, only approximately 10% of patients are aware of their kidney disease. In its 2020 Standards of Medical Care in Diabetes, the ADA recommends that all patients with type II diabetes (T2DM) undergo annual measurement of urine albumin-to-creatinine ratio (UACR). The National Kidney Foundation (NKF) has also proposed an update to the requirements for assessment of adults with diabetes including both an estimated glomerular filtration rate (eGFR) and uACR. The goal of accurately identifying patients with T2DM and CKD is to help providers intervene at an earlier stage of kidney impairment, improve renal outcomes, and reduce associated healthcare costs. Failure to adopt these guideline recommendations has widespread implications, including underestimation of the burden of CKD in the T2DM population, delays in diagnosis of renal impairment, and ultimately, underutilization of therapies that could improve clinical outcomes. This single-center, 400-patient, randomized controlled trial will assess the impact of an EPIC Best Practice Advisory (BPA; alert-based CDS tool) on guideline-directed assessment for CKD using UACR in patients with T2DM who have not had a UACR in the past year.

Conditions

Chronic Kidney Diseases; Type2Diabetes

Keywords

chronic kidney disease; diabetes; urine albumin to creatinine ratio

Outcome Measures

Primary Outcomes (1)

• Frequency of UACR testing order for CKD in patients with T2DM who have not had such testing within the past year

  Review the order entry section of the Electronic Health Record (EPIC) to make this determination

  90 days

Secondary Outcomes (1)

• Frequency of new clinical diagnosis of CKD in patients with T2DM who have not had UACR assessment within the past year

  90 days

Other Outcomes (2)

• Frequency of prescription of medical therapy for CKD in patients with T2DM, including GLP-1 receptor agonists, renin-angiotensin system antagonists (ACEi or ARB), SGLT2 inhibitors, statins, and emerging anti-inflammatory/anti-fibrotic agents

  90 days

• Frequency of referral to a nephrologist

  90 days

Study Arms (2)

Alert

EXPERIMENTAL

For patients randomly assigned to the BPA intervention group (alert group), an on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the responsible provider that his or her T2DM patient should be evaluated for CKD with UACR assessment. The provider then will be given on-screen options to either order a UACR assessment or follow a link to learn more about CKD assessment in T2DM. Should the alert-recipient elect to omit an order for UACR assessment and decline to follow a link to learn more about CKD assessment in T2DM, the provider will be able to continue on with clinic visit-related EHR documentation but will need to select an acknowledge reason (rationale) for not following the evidence-based clinical practice recommendation highlighted in the alert.

Other: Alert-based computerized decision support

No Alert

NO INTERVENTION

Providers in the "No Alert" group will not receive any on-screen notification

Interventions

Alert-based computerized decision support OTHER

For patients randomly assigned to the BPA intervention group (alert group), an on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the responsible provider that his or her T2DM patient should be evaluated for CKD with UACR assessment. The provider then will be given on-screen options to either order a UACR assessment or follow a link to learn more about CKD assessment in T2DM. Should the alert-recipient elect to omit an order for UACR assessment and decline to follow a link to learn more about CKD assessment in T2DM, the provider will be able to continue on with clinic visit-related EHR documentation but will need to select an acknowledge reason (rationale) for not following the evidence-based clinical practice recommendation highlighted in the alert.

Also known as: EPIC Best Practice Advisory

Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BWH outpatients at least 18 years of age who are evaluated in Primary Care or Brigham Medical Specialties Clinics (Cardiovascular Medicine, Endocrinology, and Diabetology) AND
• have a diagnosis of T2DM AND
• have not had a UACR measured in the past year

You may not qualify if:

• have an established diagnosis of CKD (medical history, problem list, or visit diagnosis entry in the EHR) OR
• who are undergoing renal replacement therapy (either hemodialysis or peritoneal dialysis) as UACR will be unlikely to result in diagnosis change or therapeutic intervention OR
• who have undergone renal transplantation

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bayer: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Model Details: 1:1 allocation ratio, randomized controlled trial

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: May 30, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)