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

Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; ERAS; Digital Health; Cardiac Surgery-CABG
• Intervention / Treatment: Other: ERACS with Digital Platform

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar A V Mejia, MD, PhD; Phone Number: +551126615014; Email: omarvmejia@incor.usp.br
• Study Contact Backup: Name: Pedro H Reis, MD; Phone Number: +551126615014; Email: pedro.reis@fm.usp.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-900
      • Recruiting
      • InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
    • São Paulo, São Paulo, Brazil, 05403-900
      • Not yet recruiting
      • InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
      • Principal Investigator: Omar AV Mejia, MD, PhD
      • Contact: Omar AV Mejia, MD, PhD; Phone Number: +551126615014; Email: omarvmejia@gmail.com
      • Contact: Pedro Reis, MD; Email: pedro.reis@alunmi.usp.br
      • Sub-Investigator: Marcos G Tiveron, MD, PhD
      • Sub-Investigator: Fernando F Ribas, MD, PhD
      • Sub-Investigator: Mário Issa, MD, PhD
      • Sub-Investigator: Valquiria P Campagnucci, MD, PhD
      • Sub-Investigator: Gabrielle B Borgomoni, BSc; PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care for CABG; Patients will be treated with CABG following the standard of care for each participant institution.
Experimental: 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.	Other: 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.; Other Names: ERACS; Enhanced Recovery After Cardiac Surgery; Digital ERAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 01 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.	up to 6 months after surgery
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.	up to 6 months after surgery
Patient reported experience measure(PREM)	Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.	up to 6 months after surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Instituto Dante Pazzanese de Cardiologia; Irmandade da Santa Casa de Misericordia de Sao Paulo; Faculdade de Medicina do ABC; Instituto do Coração da Universidade de São Paulo, Brazil; Irmandade Santa Casa Misericórdia Marília; Hospital Beneficence Portuguese of São Paulo
• Investigators: Principal Investigator: Omar A V Mejia, MD, PhD, InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: CABG; Cardiac Surgery; Digital Health; ERAS; ERASCS
• Other Study ID Numbers: 5811/24/022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No