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

NCT06713096 | Recruiting

• 2 other identifiers: 52842105950781921600000068
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Postoperative hospital stay

  Count of time between admission to the intensive care unit and hospital discharge (in hours and days).

  From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• Patient experience (HCAHPS)

  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

  From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.

Other Outcomes (2)

• Kirkpatrick Evaluation Model

  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.

• Patient Safety Culture (HSPSC)

  Before training, after training and experience with five pilot cases (first year of the study), and at the conclusion of randomized recruitment.

Study Arms (2)

Usual care

NO INTERVENTION

Interventional care

ACTIVE COMPARATOR

Behavioral: Tempos Certos protocol

Interventions

Tempos Certos protocol BEHAVIORAL

Improve the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists.

Interventional care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo

São Paulo, São Paulo, 5403000, Brazil

RECRUITING

Study Officials

• Gabrielle B Borgomoni, bsc, PhD student

  Instituto do coração

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar A V Mejia, md, PhD

CONTACT

555+(11) 2661-5014; omarvmejia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 3, 2024
• Study Start: November 25, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

BR (1)