Clinical trial NCT05363696: The REPLICCAR Registry and The Statewide Quality Improvement Initiative
Official title: Paulista Cardiovascular Surgery Registry (REPLICCAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Keywords: Database
Quality improvement
Mortality
Coronary artery bypass grafting
Heart valve surgery
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Hospital Samaritano Paulista
name: Hospital Israelita Albert Einstein
name: Beneficência Portuguesa de São Paulo
name: Instituto Dante Pazzanese de Cardiologia
name: Hospital das Clinicas da Universidade Estadual de Campinas
name: Hospital de Base de São Jose do Rio Preto
name: Irmandade da Santa Casa de Misericórdia de Marília
name: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Irmandade da Santa Casa de Misericórdia de Piracicaba
name: Hospital São Paulo da Universidade Federal de São Paulo
name: Hospital Pitangueiras do Grupo SOBAM
name: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
First posted: 2022-05-06
Enrollment: 9723
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (18-90 years old) underwent cardiac surgery.

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;

Eligibility criteria: 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.

Primary outcomes:
measure: Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state
timeFrame: 5 years
Secondary outcomes:
measure: Create a morbidity and mortality risk score
timeFrame: 5 years
measure: Long-term follow-up of patients included in the database
timeFrame: 10 years
measure: Assessment of the impact of patients' socioeconomic variation in its surgical evolution
timeFrame: 10 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: USP Heart Institute
city: São Paulo
country: Brazil
facility: Fabio B Jatene, MD, PhD
Study officials:
affiliation: USP Heart Institute
name: Omar AV Mejia, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, Melo de Barros E Silva PG, Nakazone MA, Sousa A, Campagnucci VP, de Sousa Vilarinho KA, Katz M, Tiveron MG, Arrais Dos Santos M, Lisboa LAF, Dallan LAO, Jatene FB; REPLICCAR II Study Group. REPLICCAR II Study: Data quality audit in the Paulista Cardiovascular Surgery Registry. PLoS One. 2020 Jul 10;15(7):e0223343. doi: 10.1371/journal.pone.0223343. eCollection 2020.