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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ERACS with Digital Platform

    Other intervention

    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.

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Standard care for CABGNo intervention 0 interventions
Group B: ERACS with Digital PlatformExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 30 days after surgery

Secondary outcomes

1

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.

Time frame
up to 01 week after surgery.
2

Morbility and Mortality

Compare morbidity and mortality rates and hospital readmission between the control and intervention groups up to 6 months after CABG.

Time frame
up to 6 months after surgery
3

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.

Time frame
up to 6 months after surgery
4

Patient reported experience measure(PREM)

Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Time frame
up to 6 months after surgery

Other outcomes

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