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Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus (CKD-DETECT)

Primary Purpose

Chronic Kidney Diseases, Type2Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alert-based computerized decision support
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, diabetes, urine albumin to creatinine ratio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alert

No Alert

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2022
Last Updated
January 11, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05342545
Brief Title
Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus
Acronym
CKD-DETECT
Official Title
Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Kidney Disease in Patients With Type II Diabetes Mellitus (CKD-DETECT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Type2Diabetes
Keywords
chronic kidney disease, diabetes, urine albumin to creatinine ratio

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation ratio, randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alert
Arm Type
Experimental
Arm Description
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.
Arm Title
No Alert
Arm Type
No Intervention
Arm Description
Providers in the "No Alert" group will not receive any on-screen notification
Intervention Type
Other
Intervention Name(s)
Alert-based computerized decision support
Other Intervention Name(s)
EPIC Best Practice Advisory
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of UACR testing order for CKD in patients with T2DM who have not had such testing within the past year
Description
Review the order entry section of the Electronic Health Record (EPIC) to make this determination
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Frequency of new clinical diagnosis of CKD in patients with T2DM who have not had UACR assessment within the past year
Description
Review the medical history and problem list sections of the Electronic Health Record (EPIC) to make this determination
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
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
Description
Review the order entry system for new prescriptions
Time Frame
90 days
Title
Frequency of referral to a nephrologist
Description
Review the order entry system for new referrals
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Piazza, MD, MS
Phone
6177326984
Email
gpiazza@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Piazza, MD, MS
Phone
617-732-6984
Email
gpiazza@bwh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus

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