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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
128
Improve the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists.
Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo
São Paulo, São Paulo, Brazil
RECRUITINGPostoperative hospital stay
Count of time between admission to the intensive care unit and hospital discharge (in hours and days).
Time frame: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)
Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality)
Incidence of key morbidities and mortality, including cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, and death.
Time frame: Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Patient-reported quality of life (SF-36)
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.
Time frame: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Anxiety and depression (HADS)
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.
Time frame: 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)
Patient experience (HCAHPS)
Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Time frame: Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).
Incremental Costs Assessed Using Micro-Costing Analysis
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.
Time frame: From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.
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