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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Postoperative Complications; Patient Care Team

Treatments: Behavioral: Postoperative Monitoring; Diagnostic Test: High-sensitivity cardiac troponin testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04187664

2019-0066

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,720 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 16 years;
• Classified as high-risk by the SAMPE Risk Model (30-day mortality >5%);
• Underwent non-cardiac surgeries at the main operating room unit;
• Referred postoperatively to the postanesthesia care unit or intensive care unit.

Exclusion criteria

• Patients undergoing procedures performed outside the operating room unit (outpatient, diagnostic, performed under local anesthesia);
• Patients undergoing cardiac surgery with cardiopulmonary bypass and / or referred to the cardiac ICU postoperatively;
• Patients undergoing organ transplantation;
• Low-risk patients (classified as <5% probability of death within 30 days by the SAMPE Risk Model).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,720 participants in 1 patient group

EXCARE Pathway Group

Experimental group

Description:

The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the SAMPE Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units, and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams.

Treatment:

Diagnostic Test: High-sensitivity cardiac troponin testing

Behavioral: Postoperative Monitoring