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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

CKD-DETECT Trial 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.Check my eligibility
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.See study design
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.

CKD-DETECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and see a doctor at BWH for primary care or a specialty like heart or diabetes care.
Select...
I have been diagnosed with type 2 diabetes.

CKD-DETECT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diabetes Mellitus, Non-Insulin-Dependent
Secondary outcome measures
Frequency of new clinical diagnosis of CKD in patients with T2DM who have not had UACR assessment within the past year
Other outcome measures
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

CKD-DETECT 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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,430 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,377 Total Patients Enrolled

Media Library

Alert-based computerized decision support Clinical Trial Eligibility Overview. Trial Name: NCT05342545 — N/A
Type 2 Diabetes Research Study Groups: Alert, No Alert
Type 2 Diabetes Clinical Trial 2023: Alert-based computerized decision support Highlights & Side Effects. Trial Name: NCT05342545 — N/A
Alert-based computerized decision support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05342545 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still ongoing for this experiment?

"As per the details provided on clinicaltrials.gov, this particular study is not currently recruiting patients. Initially posted in August 1st 2022 and last updated April 18th 2022, it does not appear to be actively looking for participants at present. However, there are a total of 1846 other trials that require volunteers right now."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~122 spots leftby Nov 2024