Florida Cardiovascular Quality Network (FCQN)

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

Study Overview

• Status: Unknown
• Conditions: Stable Ischemic Heart Disease
• Intervention / Treatment: Other: none - registry clinic followup only

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: William David, MD; Phone Number: 904-472-4444; Email: wdavid2@cfl.rr.com
• Study Contact Backup: Name: A Allen Seals, MD; Phone Number: 904-472-4444; Email: aseals@bakergilmour.com

Study Locations

• United States
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Recruiting
      • Cardiovascular Center
      • Contact: William David, MD; Phone Number: 407-833-8028; Email: wdavid2@cfl.rr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group A patients will be identified by no established SIHD, but presenting with symptoms consistent with myocardial ischemia; Group B patients will be idenitified by Established SIHD and symptoms of myocardial ischemia. All patients will have: (1) Indications for functional stress testing. All functional stress tests will be designed to provoke cardiac ischemia by using exercise or pharmacological stress agents; (2) Multiple (>3) cardiac risk factors including male gender, age > 50 years old, diabetes mellitus, hypertension, hyperlipidemia, nicotine exposure, and/or family history of cardiovascular disease.

Description

INCLUSION CRITERIA:

1. Patient presents for evaluation of SIHD and meets patient eligibility criteria as defined as SIHD Group A or SIHD Group B patient.
2. Patient is over 21 years of age
3. Patient is a stable clinic patient with the intention to continue in continuous medical care for the duration of the registry.

EXCLUSION CRITERIA:

1. Patient is diagnosed with acute coronary syndrome (unstable angina, myocardial infarction -either non-STEMI or STEMI)
2. Patient has a concomitant medical illness that may limit survival to less than 1 year

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Group A - without known pre-existing SIHD	Other: none - registry clinic followup only
Group B; Group B - with known pre-existing SIHD.	Other: none - registry clinic followup only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina Classification	Angina Classification derived from Seattle Angina Questionaire (SAQ)	1 year
Appropriate Use Criteria (AUC) for Stress Test	AUC derived from FOCUS clinical decision support software	1 year
Appropriate Use Criteria (AUC) for Coronary Intervention	AUC derived from CATH/PCI data	1 year
Fractional Flow Reserve (FFR)	FFR derived from CATH/PCI data	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Angina Classification, SAQ, and AUC for Stress Testing	Adverse Cardiac Events derived from case report form and PINNACLE database	1 year
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR	Adverse Cardiac Events derived from case report form and PINNACLE database	1 year

Collaborators and Investigators

• Sponsor: Florida Cardiovascular Quality Network

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 201600631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No