The REPLICCAR Registry & The Statewide Quality Improvement Initiative

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Cardiac Surgical Procedures

Clinical Trial Details

NCT number	NCT05363696
Study type	Observational [Patient Registry]
Source	University of Sao Paulo General Hospital
Contact
Status	Completed
Phase
Start date	August 1, 2013
Completion date	August 1, 2019

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The REPLICCAR Registry and The Statewide Quality Improvement Initiative — REPLICCAR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms