Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project

NCT ID: NCT06786819

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

ERAS; Cardiac Surgery; Cardiac Surgery-CABG; Digital Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard care for CABG

Patients will be treated with CABG following the standard of care for each participant institution.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ERACS with Digital Platform

Patient will be treated by the participant institution following a modified protocol based in the ERACS with the aid of a digital platform.

Group Type: EXPERIMENTAL

ERACS with Digital Platform

Intervention Type: OTHER

The 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 (dental, 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.

Interventions

ERACS with Digital Platform

The 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 (dental, 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.

Intervention Type: OTHER

Other Intervention Names

ERACS; Enhanced Recovery After Cardiac Surgery; Digital ERAS

Eligibility Criteria

Inclusion Criteria

• Adults over 18 years old
• Indication for primary isolated CABG (elective or urgent status)
• Own a personal cell phone
• Have internet access
• Knowledgeable in using the device
• Full understanding and agreement regarding the informed consent form (ICF)

Exclusion Criteria

• 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
• Hemoglobin less than 12 g/dL
• Users of illicit drugs
• STS score greater than 4%
• Physical or mental disabilities that prevent adherence to the protocol
• Refusal by the patient or family member

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: collaborator

Irmandade da Santa Casa de Misericordia de Sao Paulo

OTHER

Sponsor Role: collaborator

Instituto do Coração da Universidade de São Paulo, Brazil

UNKNOWN

Sponsor Role: collaborator

Hospital Beneficence Portuguese of São Paulo

UNKNOWN

Sponsor Role: collaborator

Irmandade Santa Casa Misericórdia Marília

OTHER

Sponsor Role: collaborator

Faculdade de Medicina do ABC

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Omar Asdrúbal Vilca Mejia

Study Principal Investigator, Head of Quality Improvement in Cardiac Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar A V Mejia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

Locations

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status: NOT_YET_RECRUITING

Countries

Brazil

Central Contacts

Omar A V Mejia, MD, PhD

Role: CONTACT

omarvmejia@incor.usp.br

+551126615014

Pedro H Reis, MD

Role: CONTACT

pedro.reis@fm.usp.br

+551126615014

Facility Contacts

Omar AV Mejia, MD, PhD

Role: primary

omarvmejia@gmail.com

+551126615014

Pedro Reis, MD

Role: backup

pedro.reis@alunmi.usp.br

Other Identifiers

5811/24/022

Identifier Type: -

Identifier Source: org_study_id