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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06786819
Acronym
REPLICCARIII
Enrollment
480
Registered
2025-01-22
Start date
2025-03-10
Completion date
2026-09-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiac Surgery-CABG, Digital Health, ERAS

Keywords

Cardiac Surgery, CABG, ERASCS, ERAS, Digital Health

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.

Interventions

OTHERERACS 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 (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.

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER
Instituto Dante Pazzanese de Cardiologia
CollaboratorOTHER
Irmandade da Santa Casa de Misericordia de Sao Paulo
CollaboratorOTHER
Santa Casa de Misericórdia de Marília
CollaboratorUNKNOWN
Beneficência Portuguesa de São Paulo
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Prospective, multicenter, randomized using the stepped-wedge cluster desing

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lenght of Stayup to 30 days after surgeryCompare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.

Secondary

MeasureTime frameDescription
Percentage of Completeness of Protocol Stepsup to 01 week after surgery.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 Mortalityup to 6 months after surgeryCompare morbidity and mortality rates and hospital readmission between the control and intervention groups up to 6 months after CABG.
Patient-reported outcomes (PROM)up to 6 months after surgeryEvaluate 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)up to 6 months after surgeryAssessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Countries

Brazil

Contacts

CONTACTOmar A V Mejia, MD, PhD
omar.mejia@incor.usp.br+551126615014
CONTACTGabrielle B Borgomoni, BSc, PhD student
gbborgomoni-biomedicina@hotmail.com+551126615014
PRINCIPAL_INVESTIGATOROmar A V Mejia, MD, PhD

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

STUDY_CHAIRPedro H Reis, MD

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026