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Computerized Decision Support for Chronic Kidney Disease in Type 2 Diabetes (CKD-DETECT Trial)

N/A

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BWH outpatients at least 18 years of age who are evaluated in Primary Care or Brigham Medical Specialties Clinics (Cardiovascular Medicine, Endocrinology, and Diabetology)

have a diagnosis of T2DM

Must not have

Have undergone renal transplantation

Undergoing renal replacement therapy (either hemodialysis or peritoneal dialysis) as UACR will be unlikely to result in diagnosis change or therapeutic intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This 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.

Who is the study for?

This trial is for adults over 18 with Type II Diabetes who haven't been tested for kidney disease in the past year. They should be outpatients at Brigham and Women's Hospital, receiving care in primary or specialty clinics. Those with a history of kidney transplant, known chronic kidney disease, or on dialysis are excluded.

What is being tested?

The study tests an alert-based computer decision tool designed to remind doctors to check diabetic patients for chronic kidney disease using urine tests. It aims to see if this tool helps catch kidney issues earlier by following medical guidelines more closely.

What are the potential side effects?

Since the intervention involves a decision support system rather than medication, there are no direct physical side effects. However, there may be implications related to data privacy or potential stress due to increased testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and see a doctor at BWH for primary care or a specialty like heart or diabetes care.

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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a kidney transplant.

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I am on dialysis for kidney failure.

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I have been diagnosed with chronic kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diabetes Mellitus, Non-Insulin-Dependent

Secondary study objectives

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

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AlertExperimental Treatment1 Intervention

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.

Group II: No AlertActive Control1 Intervention

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

0 / 5Eligibility criteria met