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Clinical Trials/NCT02921464
NCT02921464UnknownNot Applicable

Florida Cardiovascular Quality Network

Florida Cardiovascular Quality Network1 site in 1 country4,000 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
4,000
Locations
1
Primary Endpoint
Angina Classification

Study Overview

Brief Summary

Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Registry

Detailed Description

The Florida Cardiovascular Quality Network (FCQN) is a quality outcomes registry. In a diverse group of clinical sites in Florida, a large number of patients with known or possible stable ischemic cardiovascular disease (SIHD) referred for cardiovascular stress test will be enrolled in this quality demonstration registry. This registry is based on the hypothesis that evidence-based clinical guidelines and appropriate use criteria (AUC), when provided at the site and time of care (point of care), may improve physician clinical decisions and, thus, the overall quality and value of care for individual patients and populations. Specifically, this study registry will utilize multiple proven software tools at the point of care: (1) Seattle Angina Questionnaire (SAQ) as the method of measurement of patient angina symptoms; (2) FOCUS, American College of Cardiology (ACC) software to provide clinical decision support (CDS) as the primary method of determination of AUC in patients with a clinical indication for a cardiovascular stress test; (3) CATH/PCI, ACC / National Cardiovascular Data Registry (NCDR) to provide clinical decision support as the primary method of determination of AUC in the cardiac catheterization laboratory; (4) PINNACLE, ACC/NCDR clinical registry to provide an extensive database of clinical quality metrics; and (5) ACC CARDIOSMART software modules as the primary patient education tool for effective risk factor modification. The application of these clinically proven software tools, all applied at the point of patient care, may assist physician compliance with ACC guideline based AUC and may directly result in an increase in SIHD patients treated with guideline directed medical treatment as well as guideline directed interventional treatment. It is anticipated that this increased compliance with ACC guidelines and AUC may directly correlate with improved patient clinical outcomes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Angina Classification

Time Frame: 1 year

Angina Classification derived from Seattle Angina Questionaire (SAQ)

Appropriate Use Criteria (AUC) for Stress Test

Time Frame: 1 year

AUC derived from FOCUS clinical decision support software

Appropriate Use Criteria (AUC) for Coronary Intervention

Time Frame: 1 year

AUC derived from CATH/PCI data

Fractional Flow Reserve (FFR)

Time Frame: 1 year

FFR derived from CATH/PCI data

Secondary Outcomes

  • Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Angina Classification, SAQ, and AUC for Stress Testing(1 year)
  • Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR(1 year)

Investigators

Sponsor
Florida Cardiovascular Quality Network
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William David, MD, FACC

Director, Florida Cardiovascular Quality Network

Florida Cardiovascular Quality Network

Study Sites (1)

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