Paulista Cardiovascular Surgery Registry (REPLICCAR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9,723
- Locations
- 2
- Primary Endpoint
- Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state
Study Overview
Brief Summary
Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.
Detailed Description
METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers.
Next, quality improvement initiatives will be implemented in each center indicated by the reports.
Sample
- Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period;
- Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department;
- This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18- 90 years old.
- •CABG or heart valve surgery
- •Agreement to participate in the study signing informed consent documentation.
Exclusion Criteria
- •Re-operation
- •Impossibility to access data variables relevant to the study.
Outcomes
Primary Outcomes
Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state
Time Frame: 5 years
Guided by the database, quality initiatives will be built in order to reduce mortality, length of stay and complications in the centers participating in REPLICCAR.
Secondary Outcomes
- Assessment of the impact of patients' socioeconomic variation in its surgical evolution(10 years)
- Create a morbidity and mortality risk score(5 years)
- Long-term follow-up of patients included in the database(10 years)