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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXCARE Pathway Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative Monitoring | Behavioral | Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In-hospital mortality within 30 days | 30 days |
| Postoperative complications | Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay (LOS) | Hospital length of stay (days) | 6 months |
| Unplanned intensive care unit (ICU) admission | Admission to ICU due to clinical deterioration within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luciana Cadore Stefani, PhD | Contact | +555133598226 | lpstefani@hcpa.edu.br | |
| Adriene Stahlschmidt, MD | Contact | +555133598226 | adristah@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luciana Cadore Stefani, PhD | Hospital de Clinicas de Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035007 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29084236 | Background | Stefani LC, Gutierrez CS, Castro SMJ, Zimmer RL, Diehl FP, Meyer LE, Caumo W. Derivation and validation of a preoperative risk model for postoperative mortality (SAMPE model): An approach to care stratification. PLoS One. 2017 Oct 30;12(10):e0187122. doi: 10.1371/journal.pone.0187122. eCollection 2017. | |
| 28444280 | Background |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Quasi-experimental study, nonrandomized, pre-post intervention study
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| High-sensitivity cardiac troponin testing | Diagnostic Test | High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively |
|
| 30 days |
| Calls to rapid response team (RRT) | Number of calls to the RRT within 30 days | 30 days |
| Surgical reintervention | Number of surgical reinterventions within 30 days | 30 days |
| Hospital readmission | Hospital readmission within 30 days | 30 days |
| Failure to rescue | Death after a treatable complication within 30 days | 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:
| 3 days |
| Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360. |
| 22998715 | Background | Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. |
| 25188264 | Background | Ferraris VA, Bolanos M, Martin JT, Mahan A, Saha SP. Identification of patients with postoperative complications who are at risk for failure to rescue. JAMA Surg. 2014 Nov;149(11):1103-8. doi: 10.1001/jamasurg.2014.1338. |
| 10439777 | Background | Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050. |
| 37853279 | Derived | Stahlschmidt A, Passos SC, Dornelles DD, Polanczyk C, Gutierrez CS, Minuzzi RR, Castro SMJ, Stefani LC; and the Ex-Care Collaborative. Troponin elevation as a marker of short deterioration and one-year death in a high-risk surgical patient cohort in a low and middle income country setting: a postoperative approach to increase surveillance. Can J Anaesth. 2023 Nov;70(11):1776-1788. doi: 10.1007/s12630-023-02558-4. Epub 2023 Oct 18. |
| 35167136 | Derived | Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Gutierrez CS, Castro SMJ, Caumo W, Pearse RM; Ex-Care collaborative; Stefani LC. Enhanced peri-operative care to improve outcomes for high-risk surgical patients in Brazil: a single-centre before-and-after cohort study. Anaesthesia. 2022 Apr;77(4):416-427. doi: 10.1111/anae.15671. Epub 2022 Feb 15. |