Improving kidney disease detection in diabetes patients
Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Kidney Disease in Patients With Type II Diabetes Mellitus (CKD-DETECT)
This study is testing a new alert system in doctors' offices to help find kidney problems earlier in people with type II diabetes who haven't had a kidney test in the past year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05342545 on ClinicalTrials.gov |
What this trial studies
This initiative aims to enhance the detection of chronic kidney disease (CKD) in patients with type II diabetes mellitus (T2DM) through a computerized decision support system integrated into the electronic health record (EHR). The study will involve 400 outpatients who have not had a urine albumin-to-creatinine ratio (UACR) test in the past year. Patients will be randomly assigned to receive an alert during their clinical visit, prompting their healthcare provider to evaluate them for CKD, or to a control group without alerts. The goal is to facilitate earlier diagnosis and intervention for kidney impairment, ultimately improving patient outcomes and reducing healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18 and older with a diagnosis of type II diabetes who have not had a UACR test in the past year.
Not a fit: Patients who already have an established diagnosis of chronic kidney disease or are undergoing renal replacement therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and treatment of kidney disease in diabetic patients, improving their overall health outcomes.
How similar studies have performed: Other studies have shown success with similar alert-based decision support systems in improving clinical outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Gregory Piazza, MD, MS
- Email: gpiazza@bwh.harvard.edu
- Phone: 6177326984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.