Alert-based computerized decision support for Type2Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Type2Diabetes+5 More
Alert-based computerized decision support - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Type2Diabetes
  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type2Diabetes

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 90 days

90 days
Frequency of UACR testing order for CKD in patients with T2DM who have not had such testing within the past year
Frequency of new clinical diagnosis of CKD in patients with T2DM who have not had UACR assessment within the past year
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
Frequency of referral to a nephrologist

Trial Safety

Safety Progress

1 of 3

Other trials for Type2Diabetes

Trial Design

2 Treatment Groups

No Alert
1 of 2
Alert
1 of 2
Active Control
Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: Alert-based computerized decision support · No Placebo Group · N/A

Alert
Other
Experimental Group · 1 Intervention: Alert-based computerized decision support · Intervention Types: Other
No AlertNoIntervention Group · 1 Intervention: No Alert · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
Closest Location: Brigham and Women's Hospital · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2008First Recorded Clinical Trial
1 TrialsResearching Type2Diabetes
1051 CompletedClinical Trials

Who is running the clinical trial?

BayerIndustry Sponsor
2,130 Previous Clinical Trials
23,823,168 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,453 Previous Clinical Trials
9,700,844 Total Patients Enrolled
1 Trials studying Type2Diabetes
9,000 Patients Enrolled for Type2Diabetes

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.