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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
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring antimicrobial, antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 16, 2022
    Last Updated
    March 28, 2022
    Sponsor
    D'Or Institute for Research and Education
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    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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