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Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03781713
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Brief Summary:
This study evaluates the impact of prospective clinical surveillance with the use of triggers to identify risk of adverse events with prompt adoption of interventions on the stabilization time of critically ill patients.

Condition or disease Intervention/treatment Phase
Critical Illness Other: KDIGO Other: Delta SOFA Combination Product: Hypoglycemia Drug: Drug interaction risk D or X Drug: Antimicrobial stewardship Phase 2

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Detailed Description:

In the 1999 landmark report, "To Err is Human: Building a Safe Health System," the Institute of Medicine estimated that avoidable errors in health contributed to 44 to 98,000 deaths and more than 1 million injuries annually in the United States (1). Several years after the publication of this study, numerous initiatives have emerged to improve patient safety in the USA and the world (2).

An important advance in the detection of adverse events is the use of triggers, algorithms that use patient data to look for consistent patterns that predict the onset of an adverse event (3).

The Institute for Health Care Improvement (IHI) has developed several tools with the use of triggers. The Global Trigger Tool (GTT), developed in 2009, is a tool applied retrospectively and proved to be effective in the detection of adverse events (4). It is an easily applicable method for quantifying damage. Countries outside USA did not have the same result with their application and questioned their benefit (5,6,7).

Using a prospective clinical surveillance tool, which consisted of direct observation by a trained nurse, Forster et al (8) identified a high risk of adverse events and a significant variation of risks and sub types between services. These results have suggested that institutions will have to assess service-specific safety issues to define priorities and improvement strategies in the design of care. This model was later used by Wong et al.(9), who identified a wide range of factors contributing to adverse events. Despite the prospective methodology, the impact of the actions instituted to prevent the events was not identified in these studies.

Prospective clinical surveillance with the use of triggers as a tool to identify the risk of adverse events, with the prompt adoption of interventions and evaluation of the evidence of the expected outcome may be the answer to improving patient safety, which remains a major problem of public health 20 years after the publication of the reference "To err is human".

OBJECTIVE To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients.

METHOD This is a retrospective cohort study conducted at a surgical intensive care unit (13 beds), a medical intensive care unit (19 beds) and a surgical and trauma high complexity unit (12 beds) of a tertiary hospital. The hospital São Domingos Ethics in Research Committee approved the study (number 1.487.682).

All adult patients (18 years of age or older) who were admitted to one of the four intensive care units were included in the study, in the period from November 1, 2017 to October 30, 2018.

Patients who are readmitted and those with length of ICU stay less than 48 hours were excluded, since this is the minimum time required for the triggering of the trigger and its corresponding intervention.

Once admitted to the ICU and meeting the inclusion criteria, patients were followed by the multidisciplinary surveillance team composed of physicians, nurses, physiotherapists and pharmacists. They conducted a daily active search for the triggers in the medical records. To ensure the reliability of the data collected, each professional is responsible for a specific trigger. If one of them is activated, the team member approaches the care team responsible for the patient within 24 hours, and the data is also presented in the daily multidisciplinary round. This moment is still used to solve all doubts regarding the triggering of the trigger and its respective conduct or change in the therapeutic plan in order to reach the expected result of each trigger.

The prospective trigger tool uses indicators that are capable of predicting serious complications that increase the morbidity and mortality of ICU patients that could be preventable. The triggers used were:

  1. Acute kidney injury (KDIGO) (10) - When triggered, the patient is classified as at risk (1.5 to 1.9 x baseline creatinine or increase of 0.3 mg / dl), injury (2.0 to 2.9 x baseline creatinine) or insufficiency (3 x basal creatinine). It is expected that the risk can be identified early and that therapeutic interventions be undertaken in order to prevent progression to renal replacement therapy.
  2. Delta SOFA (11)- The SOFA (Sequential Organ Failure Assessment) of all patients are calculated on the first and third days. The increase in this score on the third day identify clinical worsening, triggering the trigger and requiring revision of the initial therapeutic plan. The impact of this change is analyzed by calculating the fifth day SOFA, which should be lower.
  3. Hypoglycaemia (glycemia <60 mg / dl) - Once this trigger is activated, it is expected that the clinical intervention will be effective to prevent the recurrence of hypoglycemia in the next 24 hours.
  4. Drug interaction risk D or X - When identifying a D or X risk interaction in the patient's prescription, the assistant team is advised to make alterations in the therapeutic plan in order to avoid adverse drug reactions.
  5. Antimicrobial stewardship - Whenever an antimicrobial regimen is started or modified it is assessed for its suitability through MALDI-TOF and sensitivity test. If there is no microbiological identification, the clinical improvement, represented by at least two of the three following parameters (leukocyte drop, absence of fever and improvement of CRP) is taken into account.

Demographic data also were collected including age, gender, hospitalization category (clinical or surgical), Charlson comorbidities index and score and SAPS 3 (Simplified Acute Physiology Score 3) with its respective risk of death.

To evaluate the impact of the tool on the time of stabilization of patients, two groups will be compared: the first will be composed of patients who did not triggered triggers and the second by patients who triggered triggers and had interventions.

For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

To evaluate the impact of the tool on the time of stabilization of patients, two groups will be compared: the first will be composed of patients who did not triggered triggers and the second by patients who triggered triggers and had interventions.

For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 10, 2018

Arm Intervention/treatment
Active Comparator: STUDY GROUP
patients who triggered triggers and had interventions. Kdigo: interventions to prevent renal replacement therapy Delta SOFA: interventions to improve SOFA score Hypoglycemia: Interventions to prevent new episodes of hypoglycemia in the next 24 hours Drug interaction risk D or X - Intervention in the therapeutic plan in order to avoid adverse drug reactions. Antimicrobial stewardship: optimization of antimicrobial therapy based on Gram stain, MALDI TOF, MIC, antimicrobial susceptibility
Other: KDIGO
Interventions to prevent renal replacement therapy

Other: Delta SOFA
interventions to improve SOFA score

Combination Product: Hypoglycemia
Interventions to prevent new episodes of hypoglycemia in the next 24 hours

Drug: Drug interaction risk D or X
Intervention in the therapeutic plan in order to avoid adverse drug reactions.

Drug: Antimicrobial stewardship
Optimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility

No Intervention: CONTROL GROUP
patients who did not triggered triggers



Primary Outcome Measures :
  1. To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients. [ Time Frame: 3 months ]
    For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All adult patients admitted to the ICU with expexted length of stay of at least 48 hours -

Exclusion Criteria: End of life and exclusive palliative care

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781713


Locations
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Brazil
Hospital São Domingos
Sao Luis, Maranhão, Brazil, 65060-645
Hospital Sao Domingos
Sao Luis, MA, Brazil, 65060-642
Sponsors and Collaborators
Hospital Sao Domingos
Investigators
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Study Chair: JOSE R AZEVEDO, MD. PhD Hospital Sao Domingos

Publications of Results:
1. To err is human: building a Safer Health System. Institute of Medicine (IOM). Washington National Academy Press; 2000.
4. Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. 2nd edn. Cambridge, Massachusetts Institute for Healthcare Improvement, 2009.
5. Shimada S, Rivard PE, Mull J, et al. Triggers and Targeted Injury Detection Systems: Aiming for the Right Target With the Appropriate Tool. 2009.
10. Kdigo Clinical Practice Guideline for acute kidney injury. Kidney International 2012; 2 9Suppl 1).

Other Publications:
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Responsible Party: José Raimundo Araujo de Azevedo, MD; PhD, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT03781713     History of Changes
Other Study ID Numbers: CONEP 1.487.682
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
prospective
surveillance
trigger
stabilization
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents