Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model
Primary Purpose
Nosocomial Infection, Sepsis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation of the predictive model for an antimicrobial management program
Sponsored by
About this trial
This is an interventional prevention trial for Nosocomial Infection focused on measuring antimicrobial, antibiotics
Eligibility Criteria
Inclusion Criteria:
- prescribers from the hospital units participating in the study.
Exclusion Criteria:
- prescribers who do not work in intensive care units.
- refusal to participate
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Application of an antimicrobial stewardship program in ICUs
Arm Description
Application of an antimicrobial stewardship program in Brazilian ICUs using machine learning techniques and an educational model
Outcomes
Primary Outcome Measures
Antimicrobial consumption
It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT):Duration of Treatment with antibiotics.
Antimicrobial consumption
It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT): Duration of Treatment with antibiotics
Secondary Outcome Measures
Mortality
ICU Mortality
Gram-positive infection
Number of patients with missed Gram-positive infection
Full Information
NCT ID
NCT05312034
First Posted
March 16, 2022
Last Updated
March 28, 2022
Sponsor
D'Or Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT05312034
Brief Title
Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model
Official Title
Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Antimicrobial agents are frequently used empirically and include therapy for both Gram-positive and Gram-negative bacteria. In Brazil, multidrug-resistant Gram-negative pathogens are the cause of most nosocomial infections in ICUs. Therefore, the excessive use of antimicrobials to treat Gram-positive bacteria represents an opportunity to reduce unnecessary antibiotic use in critically ill patients. Besides, the success of a program aimed at reducing the use of antibiotics to treat gram-positive bacteria could also evolve to include other microorganisms, such as gram-negative bacteria and fungi. Analyzing data from the ICUs of the associated hospital network, high use of broad-spectrum antibiotics and vancomycin were observed, although MRSA infections rarely occur.
Thus, if physicians could identify patients at high risk of infection by gram-positive bacteriaa reduction in antibiotic consumption could occur.. The more accurate treatments could result in better patient outcomes, reduce the antibiotics' adverse effects, and decrease the prevalence of multidrug-resistant bacteria. Therefore, our main goal is to reduce antibiotic use by applying an intervention with three main objectives: (i) to educate the medical team, (ii) to provide a tool that can help physicians prescribing antibiotics, and (iii) to find and reduce differences in antibiotic prescription between hospitals with low- and high-resources.
To achieve these objectives, he same intervention will be applied in ICUs of two hospitals with different access to resources. Both are part of a network of hospitals associated with our group.
First, baseline data corresponding to patient characteristics, antibiotic use, microbiological outcomes and current administration programs in practice at selected hospitals will be analyzed. TThen, a predictive model to detect patients at high risk of Gram-positive infection will be developed. After that, t will be applied for three months as an educational tool to improve medical decisions regarding antibiotic prescription. After obtaining feedback and suggestions from physicians and other hospital and infection control members, the model will be adjusted and applied in the two selected hospitals for use in real time. For one year, we will monitor the intervention and analyze the data monthly.
Detailed Description
This proposal is a five-step quality improvement project.
Analysis of baseline data [3 months]: Retrospective data will be collected from ten hospitals of Rede D'Or São Luiz. Patient characteristics, microbiological results and the use of antimicrobial agents will be analyzed. Stewardship programs currently in place will also be recorded.
Development of the predictive model [3 months]: Collected data and machine learning techniques will be used to develop a predictive model to identify patients at risk of Gram-positive infection. This model will be evaluated using standard methods (e.g., accuracy and confusion matrix) and through clinical decision curves. This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents.
Educational and calibration phase [3 months]: Firstly it will be used use the predictive model as a simulation tool to educate physicians. For three months, physicians will use the model to understand the main factors associated with Gram-positive infection. They will test the model using real-case data previously collected at the hospitals. The model will provide them information such as the probability of that patient having a Gram-positive infection and the proportion of infected patients in that ICU and hospital.
After that, a meeting with all ICU and infection control members from participating hospitals will be held. A specific probability cutoff will be defined for starting gram-positive coverage. For example, the members can define that they feel comfortable not treating empirically gram-positive bacteria if the predicted probability is below a given threshold (say 5%). Quality improvement protocol will also involve other traditional methods to decrease antibiotic use, including audit feedback and daily remembrances to withdraw gram-positive antibiotic coverage. Educational material will be developed and provided for all sites, as well as in-site training.
This phase will motivate the involvement of the hospital members, especially physicians, which can improve engagement to the intervention to be implemented afterward. Hopefully, it will also generate insights and feedback from the medical team to improve the tool to be implemented.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection, Sepsis
Keywords
antimicrobial, antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A predictive model to identify patients at risk of Gram-positive infection. This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents.
The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Application of an antimicrobial stewardship program in ICUs
Arm Type
Experimental
Arm Description
Application of an antimicrobial stewardship program in Brazilian ICUs using machine learning techniques and an educational model
Intervention Type
Behavioral
Intervention Name(s)
Implementation of the predictive model for an antimicrobial management program
Intervention Description
Firstly it will be used the predictive model as a simulation tool to educate physicians. For three months, physicians will use the model to understand the main factors associated with Gram-positive infection. They will test the model using real-case data previously collected at the hospitals. The model will provide them information such as the probability of that patient having a Gram-positive infection and the proportion of infected patients in that ICU and hospital.
This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents.
The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.
Primary Outcome Measure Information:
Title
Antimicrobial consumption
Description
It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT):Duration of Treatment with antibiotics.
Time Frame
Baseline
Title
Antimicrobial consumption
Description
It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT): Duration of Treatment with antibiotics
Time Frame
During the intervention
Secondary Outcome Measure Information:
Title
Mortality
Description
ICU Mortality
Time Frame
number of deaths in 60 days
Title
Gram-positive infection
Description
Number of patients with missed Gram-positive infection
Time Frame
immediately after the microbiologics analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prescribers from the hospital units participating in the study.
Exclusion Criteria:
prescribers who do not work in intensive care units.
refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Bozza, PhD
Phone
55 21 993031551
Email
bozza.fernando@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Bozza, PhD
Organizational Affiliation
D'Or Institute for Research and Education (IDOR)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model
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