About this trial
Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults over 18 years old
Indication for primary isolated CABG (elective or urgent status)
Own a personal cell phone
Have internet access
Disqualifiers
Indication for associated surgery
Glycosylated hemoglobin level greater than 8%
Creatinine clearance less than 30 mL/min
Pre-operative atrial fibrillation or use of pre-operative anticoagulation
Trial design
Parallel
Treatments tested in this trial
ERACS with Digital Platform
Other interventionThe assistance provided to patients in the intervention group will be sequential and prospective. The project will utilize an app based on protocols that prepare patients for rapid recovery (ERAS), starting before surgery and extending up to 30 days post-discharge. This includes pre-operative evaluations (psychological, nutritional, and others), scheduling and confirming hospital admission, and following specific protocols during surgery and intensive care. The app aims to enhance communication and teamwork, improving patient-centered care. It will feature modules for patient and family education, team communication, and activity management through a dashboard. Additionally, it will facilitate interaction with patients through messages and surveys, monitor multidisciplinary team communication, and collect patient-reported outcomes 30 days after the surgical procedure.
Treatment groups
Trial outcomes
Primary outcomes
Lenght of Stay
Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.
Secondary outcomes
Percentage of Completeness of Protocol Steps
Compare adherence to protocol metrics through measure of the execution of the protocol steps by each participant center, during the intervention period. up to one week after surgery.
Morbility and Mortality
Compare morbidity and mortality rates and hospital readmission between the control and intervention groups up to 6 months after CABG.
Patient-reported outcomes (PROM)
Evaluate and patient-reported outcome measures following the questionnaire published by Ben-Ali W, Lamarche Y, Carrier M, Demers P, Bouchard D, El-Hamamsy I, et al. Use of Mobile-Based Application for Collection of Patient-Reported Outcomes in Cardiac Surgery. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. 2021 Nov 1;16(6):536-44. at 01 month and 6 months after surgery. This questionary assess self reported pain, quality of recovery, anxiety and engagement of the patient with his/her recovery.
Patient reported experience measure(PREM)
Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Sponsors and contacts
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University of Sao Paulo General Hospital
Lead sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo
Collaborator
Santa Casa de Misericórdia de Marília
Collaborator
Beneficência Portuguesa de São Paulo
Collaborator