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

Not Applicable

Not yet recruiting

• Conditions: ERAS; Cardiac Surgery; Cardiac Surgery-CABG; Digital Health

• Registration Number: NCT06786819
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-07
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Study Start: 2025-03-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lenght of Stay	up to 30 days after surgery	Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.

Secondary Outcome Measures

Name	Time	Method
Percentage of Completeness of Protocol Steps	up 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 Mortality	up to 6 months after surgery	Compare 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 surgery	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.
Patient reported experience measure(PREM)	up to 6 months after surgery	Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Trial Locations

Locations (1)

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP; 🇧🇷 São Paulo, Brazil