Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910684
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-06-06
Brief Title:
Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study
Sponsor:
Qure Healthcare LLC
Organization:
Qure Healthcare LLC
Study Overview
Official Title:
Establishing Clinical Utility Evidence for Chronic Disease Management Testing A CPV and Chart Abstraction Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
This is a national-level research study of primary care physicians The purpose of this study is to assess the clinical evaluation and management drug procedures counseling and others of a subset of common patient care indications
Detailed Description:
In the original study protocol approved on October 19th 2021 which the investigators are now referring to as Phase 1 the investigators measured changes in clinical practice using Clinical Performance and Value CPVs vignettes described below Phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the CDMT results on physicians clinical decision-making
CPVs are QUREs scientifically-validated measurement tool first described in JAMA 2000 and now used in scores of scientific investigations In this research and derivative peer-reviewed publications QUREs CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers
This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting
Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice These physicians will be given free of charge the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including but not limited to blood pressure control blood sugar control and parameters of disease progression
CPVs are QUREs scientifically-validated measurement tool first described in JAMA 2000 and now used in scores of scientific investigations In this research and derivative peer-reviewed publications QUREs CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers
This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting
Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice These physicians will be given free of charge the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including but not limited to blood pressure control blood sugar control and parameters of disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None