The REPLICCAR Registry and The Statewide Quality Improvement Initiative

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05363696

Collaborator

Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (Other), Hospital Samaritano Paulista (Other), Hospital Israelita Albert Einstein (Other), Beneficência Portuguesa de São Paulo (Other), Instituto Dante Pazzanese de Cardiologia (Other), Hospital das Clinicas da Universidade Estadual de Campinas (Other), Hospital de Base de São Jose do Rio Preto (Other), Irmandade da Santa Casa de Misericórdia de Marília (Other), Irmandade da Santa Casa de Misericórdia de São Paulo (Other), Irmandade da Santa Casa de Misericórdia de Piracicaba (Other), Hospital São Paulo da Universidade Federal de São Paulo (Other), Hospital Pitangueiras do Grupo SOBAM (Other), Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP (Other)

9,723

Enrollment

Locations

Actual Duration (Months)

4861.5

Patients Per Site

67.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgical Procedures	Procedure: Coronary artery bypass grafting (CABG) Procedure: Heart valve surgery

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 [Patient Registry]

Actual Enrollment :

9723 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Paulista Cardiovascular Surgery Registry (REPLICCAR)

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Aug 1, 2019

Outcome Measures

Primary Outcome Measures

Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state [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 Outcome Measures

Create a morbidity and mortality risk score [5 years]
Create a morbidity and mortality risk score, in order to guide the care and interventions of patients undergoing cardiac procedures, in order to prevent morbidity and mortality outcomes.
Long-term follow-up of patients included in the database [10 years]
Long-term follow-up of patients included in the database, providing an opportunity to assess quality of life, evolution and deaths after hospital discharge.
Assessment of the impact of patients' socioeconomic variation in its surgical evolution [10 years]
Assessment of the impact of patients' socioeconomic variation on their evolution in terms of morbidity and mortality (short and long term).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USP Heart Institute	São Paulo		Brazil	05403-900
2	Fabio B Jatene, MD, PhD	São Paulo		Brazil	05409011

Sponsors and Collaborators

University of Sao Paulo General Hospital
Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Hospital Samaritano Paulista
Hospital Israelita Albert Einstein
Beneficência Portuguesa de São Paulo
Instituto Dante Pazzanese de Cardiologia
Hospital das Clinicas da Universidade Estadual de Campinas
Hospital de Base de São Jose do Rio Preto
Irmandade da Santa Casa de Misericórdia de Marília
Irmandade da Santa Casa de Misericórdia de São Paulo
Irmandade da Santa Casa de Misericórdia de Piracicaba
Hospital São Paulo da Universidade Federal de São Paulo
Hospital Pitangueiras do Grupo SOBAM
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP