Clinical trial NCT06713096: Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
Official title: Prospective and Randomized Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enhanced Recovery After Surgery
Quality Improvement
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)
Secondary outcomes:
measure: Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality)
timeFrame: Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
measure: Patient-reported Patient-reported quality of life (SF-36)
timeFrame: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
measure: Patient-reported Anxiety and depression (HADS)
timeFrame: 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)
measure: Patient experience (HCAHPS)
timeFrame: Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).
measure: Incremental Costs Assessed Using Micro-Costing Analysis
timeFrame: From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.
Other outcomes:
measure: Kirkpatrick Evaluation Model
timeFrame: Levels 1 and 2: Before training, after training (5 pilot cases conducted in year 1), and at study conclusion. Level 3: After pilot cases (year 1) and study conclusion. Level 4: At study conclusion.
measure: Patient Safety Culture (HSPSC)
timeFrame: Before training, after training and experience with five pilot cases (first year of the study), and at the conclusion of randomized recruitment.
Locations:
city: São Paulo
country: Brazil
facility: Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo
Study officials:
affiliation: Instituto do coração
name: Gabrielle B Borgomoni, bsc, PhD student
role: PRINCIPAL_INVESTIGATOR
References: