Clinical trial NCT06786819: Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ERAS
Cardiac Surgery
Cardiac Surgery-CABG
Digital Health
Keywords: Cardiac Surgery
CABG
ERASCS
ERAS
Digital Health
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
name: Irmandade da Santa Casa de Misericordia de Sao Paulo
name: Instituto do Coração da Universidade de São Paulo, Brazil
name: Hospital Beneficence Portuguese of São Paulo
name: Irmandade Santa Casa Misericórdia Marília
name: Faculdade de Medicina do ABC
First posted: 2025-01-22
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Lenght of Stay
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Percentage of Completeness of Protocol Steps
timeFrame: up to 01 week after surgery.
measure: Morbility and Mortality
timeFrame: up to 6 months after surgery
measure: Patient-reported outcomes (PROM)
timeFrame: up to 6 months after surgery
measure: Patient reported experience measure(PREM)
timeFrame: up to 6 months after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
state: SP
city: São Paulo
country: Brazil
facility: InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
Study officials:
affiliation: InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
name: Omar A V Mejia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: