NCT04187664

Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Surgical Population

Implementation of the Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Non-cardiac Surgical Population: Impact on Morbidity and 30-day Mortality

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,720 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Postoperative Complications
• Patient Care Team

Interventions

Type	Name	Description
BEHAVIORAL	Postoperative Monitoring	Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care.
DIAGNOSTIC_TEST	High-sensitivity cardiac troponin testing	High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively

Timeline

• Start date: 2019-01-30
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2019-12-05
• Last updated: 2020-06-26

Locations

1 site across 1 country: Brazil