Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

Not Applicable

Recruiting

• Conditions: Enhanced Recovery After Surgery; Quality Improvement

• Registration Number: NCT06713096
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care.

Primary Objective:

Compare postoperative hospital stay between the rapid recovery group and the usual care group.

Secondary Objectives:

Assess morbidity and mortality between both groups.

Evaluate patient satisfaction using validated tools.

Analyze incremental costs associated with both approaches.

Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method).

Evaluate adherence to rapid recovery protocol metrics by healthcare teams.

Measure changes in patient safety culture among healthcare professionals.

Hypothesis:

The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP).

This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2023-11-22
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Adult patients (>18 years old)
• Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
• Signed informed consent form (ICF)

Exclusion Criteria

• Emergency patients
• Severe ventricular dysfunction (ejection fraction <30%)
• Renal impairment (creatinine clearance <30 mL/min)
• Atrial fibrillation or need for oral anticoagulation
• Moderate-to-severe anemia (hematocrit <32%)
• STS risk score >4%
• Patient and/or family disagreement with the protocol
• Failure to sign the informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative hospital stay	From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)	Count of time between admission to the intensive care unit and hospital discharge (in hours and days).

Secondary Outcome Measures

Name	Time	Method
Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality)	Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)	Incidence of key morbidities and mortality, including cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, and death.
Patient-reported Patient-reported quality of life (SF-36)	Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)	Quality of life assessed by SF-36 survey before surgery and 30 days after hospital discharge. Scores range from 0 to 100, with higher scores indicating better quality of life.
Patient-reported Anxiety and depression (HADS)	Intervention group: Before surgery, at hospital discharge, and 30 days after hospital discharge. Control group: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)	Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for both anxiety and depression subscales, with higher scores indicating greater levels of anxiety or depression.
Patient experience (HCAHPS)	Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).	Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Incremental Costs Assessed Using Micro-Costing Analysis	From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.	Incremental costs assessed through a detailed micro-costing analysis of preoperative, intraoperative, and postoperative phases. Costs will include hospital stay (ward and intensive care unit), multiprofessional care, medications (including blood transfusion), surgical room costs (surgery time and equipment), operational equipment, consumables, imaging exams, and medical supplies. Costs associated with readmissions within 30 days after discharge will also be included.

Trial Locations

Locations (1)

Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo; 🇧🇷 São Paulo, Brazil