High risk surgical patients are subject to complications that impact rehabilitation time, overall mortality and costs. This project proposes the creation of a post-surgery care pathway called Extended Care in High-Risk Surgical Patients (EXCARE) in the form of coordinated multiprofessional actions dedicated to high-risk non-cardiac surgical patients with the aim of improving the postoperative outcomes. The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the Anaesthesia and Perioperative Medicine Service (SAMPE) Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units (ICU), and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams. This is a quasi-experiment in which the clinical effectiveness of the extended care will be analyzed using a before-and-after comparison, the primary outcome being 30-day surgical mortality and postoperative complications at day 7 defined by PostOperative Morbidity Survey (POMS), a reliable and valid survey of short-term postoperative morbidity in major elective surgery. POMS domains evaluated are: pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological and wound complications. Secondary outcomes include 30-day mortality, hospital length of stay, number of Rapid Response Team calls, unplanned postoperative ICU admission, surgical reintervention, failure to rescue and hospital readmission. High-sensitive cardiac troponin (hs-cTn) levels will be measured before surgery and daily until 48 hours postoperatively to identify patients with myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit).
Study Strengths and Limitations: This is the first study to evaluate the implementation of surgical patient stratification using the SAMPE Risk Model, pioneering the creation of a multidisciplinary care pathway that involves nursing and medical teams, and can be consolidated as a future standard of assistance. The care bundle, using an objective risk communication tool, is expected to integrate the teams involved in the perioperative care, reducing the fragmentation of care and, consequently, postoperative complications. The study is designed to use historical controls (before and after) and is therefore inherently vulnerable to the biases of this design. It will be conducted in a single teaching hospital and referral centre that provides care to patients from across southern Brazil through the national unified health system centre, which can therefore limit its external validity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,720
Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care.
High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGMortality
In-hospital mortality within 30 days
Time frame: 30 days
Postoperative complications
Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains
Time frame: 7 days
Length of stay (LOS)
Hospital length of stay (days)
Time frame: 6 months
Unplanned intensive care unit (ICU) admission
Admission to ICU due to clinical deterioration within 30 days
Time frame: 30 days
Calls to rapid response team (RRT)
Number of calls to the RRT within 30 days
Time frame: 30 days
Surgical reintervention
Number of surgical reinterventions within 30 days
Time frame: 30 days
Hospital readmission
Hospital readmission within 30 days
Time frame: 30 days
Failure to rescue
Death after a treatable complication within 30 days
Time frame: 30 days
High-sensitivity cardiac troponin levels
High-sensitivity cardiac troponin (hs-cTn) elevation due to myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit.) 3 categories: * Acute myocardial injury due to myocardial infarction (requires at least 1 of the following: symptoms of myocardial ischemia, new ischemic electrocardiographic changes, new ischemic regional wall-motion abnormalities on cardiac imaging, and/or an acute coronary thrombus on coronary angiography) or nonischemic causes (documented nonischemic etiology); * Myocardial Injury After Noncardiac Surgery (MINS): myocardial injury caused by ischemia (that may or may not result in necrosis), has prognostic relevance and occurs during or within 30 days after noncardiac surgery. * Chronic myocardial injury: stable but elevated troponin.
Time frame: 3 days
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