Chronic Kidney DiseasesCKD-DETECTNCT05342545
Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus
A study testing Alert-based computerized decision support in people with Chronic Kidney Diseases and Type2Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Type2Diabetes
- What is being tested?
- Alert-based computerized decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Kidney Disease in Patients With Type II Diabetes Mellitus (CKD-DETECT)
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.
Read the detailed description
The study is a 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial of an EPIC EHR BPA. The allocation ratio will be 1:1 for an EPIC BPA versus no notification with randomization by Attending Physician of Record, using odd or even provider ID number, to minimize cluster-effect. While the study will randomize patients by Attending Physician of Record, the observational unit will be the patient.
The study will use a BPA within EPIC that will integrate with the EHR medical history, visit diagnoses, and problem list to identify outpatients with a diagnosis of T2DM and without an established diagnosis of CKD. The BPA will then search the laboratory results section of the EHR for a UACR result within the last year. If the patient with T2DM has not had a UACR result within the past year, he or she will be randomly assigned to the BPA intervention group (alert group) or the control (no alert) group according the Attending Physician of Record's provider ID number. 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. The provider then will be given on-screen options to either order a UACR or follow a link to learn more about CKD assessment in T2DM.
- Conditions
- Chronic Kidney Diseases, Type2Diabetes
- Being tested
- Alert-based computerized decision support
- Keywords
- chronic kidney disease, diabetes, urine albumin to creatinine ratio
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert-based computerized decision supportOther
Also called EPIC Best Practice Advisory
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Alert-based computerized decision support |
| No Alert | No intervention | Providers in the "No Alert" group will not receive any on-screen notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Review the medical history and problem list sections of the Electronic Health Record (EPIC) to make this determination
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation ratio, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342545
- Sponsor's protocol ID
- 2022P000778
- Acronym
- CKD-DETECT
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2022
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldhaber SZ, Rashedi S, Pfeferman M, Leyva H, Bacare B, Chopard R, Robinson ES, Lan Z, Bikdeli B, Piazza G; CKD-DETECT investigators. Electronic alert-based computerized decision support for detection of chronic kidney disease in type 2 diabetes mellitus: CKD-DETECT. Am J Med. 2026 Sep;139(9):1228-1236. doi: 10.1016/j.amjmed.2026.04.022. Epub 2026 Apr 22.
PubMed 42031191
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Kidney Disease in Patients With Type II Diabetes Mellitus (CKD-DETECT)
- ClinicalTrials.gov ID
- NCT05342545
- Acronym / sponsor ID
- CKD-DETECT / 2022P000778
- Conditions
- Chronic Kidney Diseases, Type2Diabetes
- Keywords
- chronic kidney disease, diabetes, urine albumin to creatinine ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial of an EPIC EHR BPA. The allocation ratio will be 1:1 for an EPIC BPA versus no notification with randomization by Attending Physician of Record, using odd or even provider ID number, to minimize cluster-effect. While the study will randomize patients by Attending Physician of Record, the observational unit will be the patient.
The study will use a BPA within EPIC that will integrate with the EHR medical history, visit diagnoses, and problem list to identify outpatients with a diagnosis of T2DM and without an established diagnosis of CKD. The BPA will then search the laboratory results section of the EHR for a UACR result within the last year. If the patient with T2DM has not had a UACR result within the past year, he or she will be randomly assigned to the BPA intervention group (alert group) or the control (no alert) group according the Attending Physician of Record's provider ID number. 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. The provider then will be given on-screen options to either order a UACR or follow a link to learn more about CKD assessment in T2DM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 allocation ratio, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alert | Experimental | Other: Alert-based computerized decision supportFor 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. |
| No Alert | No intervention | –Providers in the "No Alert" group will not receive any on-screen notification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alert-based computerized decision supportAlso: EPIC Best Practice AdvisoryFor 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 |
Primary outcome
Frequency of UACR testing order for CKD in patients with T2DM who have not had such testing within the past year
Time frame: 90 days
Review the order entry section of the Electronic Health Record (EPIC) to make this determination
1 secondary outcome
Frequency of new clinical diagnosis of CKD in patients with T2DM who have not had UACR assessment within the past year
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Derived from this study: PubMed 42031191Goldhaber SZ, Rashedi S, Pfeferman M, Leyva H, Bacare B, Chopard R, Robinson ES, Lan Z, Bikdeli B, Piazza G; CKD-DETECT investigators. Electronic alert-based computerized decision support for detection of chronic kidney disease in type 2 diabetes mellitus: CKD-DETECT. Am J Med. 2026 Sep;139(9):1228-1236. doi: 10.1016/j.amjmed.2026.04.022. Epub 2026 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert-based computerized decision support in people with Chronic Kidney Diseases and Type2Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of UACR testing order for CKD in patients with T2DM who have not had such testing within the past year (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.