Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05342545
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-04-18
Brief Title:
Decision Support for Detection of Chronic Kidney Disease in Type II Diabetes Mellitus
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Kidney Disease in Patients With Type II Diabetes Mellitus CKD-DETECT
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CKD-DETECT
Brief Summary:
While data from the National Health and Nutrition Examination Survey NHANES estimate that 369 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
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 11 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 Records 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
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 Records 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None