Derivation and Validation of the Extended Care (Ex-Care) Model II (Ex-CareII)
March 21, 2023 updated by: Hospital de Clinicas de Porto Alegre
Derivation and Validation of a National Multicenter In-hospital Mortality Risk Stratification Model - the Ex-Care Model II
The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is:
•Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery?
Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death).
The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
From four predictors collected preoperatively ( American Society of Anesthesiology Physical Status (ASA-PS) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the Ex-Care II model.
Discrimination and calibration measures will be used to determine the accuracy of the model.
In addition, each predictor will have their odds ratio calculated for the study outcome.
Once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.
Study Type
Observational
Enrollment (Actual)
107372
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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RS
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Porto Alegre, RS, Brazil, 91360390
- Hospital de Clinicas de Porto Alegre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged 16 years or older undergoing surgery in hospitals in different regions of Brazil
Description
Inclusion Criteria:
- Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study
Exclusion Criteria:
- Diagnostic procedures, with sedation only or with local anesthesia
- Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation
- In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Derivation Cohort
The derivation cohort will correspond to approximately 70% of the total sample to be analyzed in the study.
The Ex-Care II risk model will build upon it.
It is composed of patients operated in the participating institutions.
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Validation Cohort
Composed of the remaining 30% of the sample.
It will be used for the external validation of the Ex-Care II model
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Develop and validate a model for predicting the risk of in-hospital death within 30 days postoperatively, from a sample composed of patients operated in Brazil
Time Frame: Surgery day up to 30 days postoperatively
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From four predictors collected preoperatively, the developed model will be able to estimate the probability of in-hospital death of patients undergoing surgery in Brazilian hospitals.
For the creation of this tool, multilevel logistic regression will be made with hospital as a random effect
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Surgery day up to 30 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Develop smartphone application contemplating the new model developed
Time Frame: Preoperative
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In order to facilitate the use of the Ex-Care II model by health professionals involved in perioperative care, it will be created and made available on the main platforms for smartphones application that will allow the measurement of surgical risk by this new tool.
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Preoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luciana C Stefani, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Anticipated)
November 30, 2023
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.0192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.