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Enhancing European Management of Analgesia, Sedation and Delirium

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ClinicalTrials.gov Identifier: NCT03553719
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Brief Summary:

This prospective, multicenter study aims to evaluate the effect of routine training of intensive care unit (ICU) staff on the implementation rate of screening tools for pain, agitation and delirium (PAD) ) in three one day point-prevalence analyses.

The evaluations will take the form of one day point-prevalence analyses, administered both pre- and post-training phase.

The 6-week training block consists of e-learning material in the form of text content, slides and brief training videos.

At each point-prevalence analysis, data of approximately 300 patients in 14 participating centers will be collected.

Data collection focuses primarily on parameters of routine patient management (e.g. medications, screening scores) and basic patient characteristics (e.g. illness severity, age, major comorbidities).

Additionally, one member of each major profession in the ICU care team (attending physician, resident physician, nurse) will be given a brief online questionnaire to gauge their estimate of routine practice with regards to delirium screening and delirium prevalence in their ICU.

Each participating patient will also receive one "gold standard" delirium screening with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU score) performed by a trained expert.


Condition or disease
Delirium

Detailed Description:

ICU-staff that is adequately trained in PAD-screening and -management is part of guideline recommendations internationally, and staff training should take place accordingly. Prior studies have hinted at low implementation rates of delirium screening intensive care units and an overall low reliability of the documented scores.

The study's rationale is to evaluate staff perceptions regarding delirium screening practice in their ICU, and evaluate the validity of routine delirium screening scoring (compared to an expert-screen). Subsequently, the effect of a training block for ICU staff on routine delirium screening frequency and validity will be assessed.

The implemented training package contains online lectures, instructional videos, educational handouts, and a bedside teaching component over the course of 6 weeks.

On each point-prevalence day three members of the ICU staff (attending/consultant, trainee physician, nurse) will fill out their respective questionnaire (attending CRF, physician CRF, nurse CRF). These questionnaires ask for estimates of delirium prevalence in their respective ICU, as well as estimates on the frequency of delirium screening implementation.

Subsequently, the local study coordinator will evaluate all patients that have received treatment in the ICU during the past 24 hours according to the inclusion and exclusion criteria. Each included patient will receive a pseudonym and the study coordinator will fill out one electronic case report file (eCRF, see list of items) per included patient.

A member of staff who is trained in administering the CAM-ICU screening tool will then evaluate all included patients, and enter the respective score result in each patient's "expert CRF".


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Study Type : Observational
Estimated Enrollment : 864 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhancing European Management of Analgesia, Sedation and Delirium - Implementation and Validity of Pain, Agitation and Delirium Screening in the ICU - an International, Prospective Multicenter Observational Trial
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
One day point-prevalence analysis 1
Data on the management of intensive care unit patients ≥18 years will be collected. Data of approximately 288 patients per point-prevalence analysis will be collected.
One day point-prevalence analysis 2

Before the start of the second one day point-prevalence analysis a training package is conducted at each study center. This contains online lectures, instructional videos, educational handouts, and a bedside teaching component over the course of 6 weeks. The effect of a training block for intensive care unit staff on routine delirium screening rate and the change of the other outcome measures will be assessed.

During the one day point-prevalence analysis 2 data on the management of intensive care unit patients ≥18 years will be collected. Data of approximately 288 patients per point-prevalence analysis will be collected.

One day point-prevalence analysis 3
Data on the management of intensive care unit patients ≥18 years will be collected. Data of approximately 288 patients per point-prevalence analysis will be collected.



Primary Outcome Measures :
  1. Delirium screening rate [ Time Frame: Up to 24 hours ]
    The delirium screening rate is documented and calculated according to patients´ records.


Secondary Outcome Measures :
  1. Delirium screening rate [ Time Frame: Up to 24 hours ]
    The rate of occurrence of delirium screening of some form is documented according to the estimation by clinical staff: One member of each major profession in the ICU care team (attending physician, trainee physician, nurse) will be given a brief online questionnaire to gauge their estimate of routine practice with regards to delirium screening and delirium prevalence in their ICU.

  2. Delirium screening type - as documented in the patient chart [ Time Frame: Up to 24 hours ]
    During each point prevalence analysis, one investigator at each study site will search the respective patient charts for documentation of delirium screening type used and the scores during the preceding 24 hours.

  3. Delirium screening score - as documented in the patient chart [ Time Frame: Up to 24 hours ]
    During each point prevalence analysis, one investigator at each study site will search the respective patient charts for documentation of delirium screening scores during the preceding 24 hours.

  4. Confusion assessment method for the intensive care unit (CAM-ICU) [ Time Frame: Up to 24 hours ]
    CAM-ICU form patient records

  5. Confusion assessment method for the intensive care unit (CAM-ICU) scoring by trained expert [ Time Frame: Up to 24 hours ]

    Each participating patient will receive one "gold standard" delirium screening with the CAM-ICU score performed by a trained expert. Each participating patient will receive one "gold standard" delirium screening with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score performed by a trained expert.

    The test assesses a patient's state of confusion and serves as a screening test for ICU-related delirium.

    The tested patient can either be "positive" or "negative" for delirium, or "not testable", if the patient's state of consciousness does not allow administration of the test.


  6. Extracorporeal organ support [ Time Frame: Up to 24 hours ]
    The type of extracorporeal organ support measures that a patient received on the day of analysis, as well as during the course of his ICU stay before the day of analysis will be documented.

  7. Parameters of infection [ Time Frame: Up to 24 hours ]
    The patient's sepsis status according to SIRS- as well as Sepsis-3-criteria on the day of analysis will be documented.

  8. Use of relevant medication [ Time Frame: Up to 24 hours ]
    The use of sedatives, analgesics, antipsychotics, vasopressors and inotropes during the day of analysis will be documented, as well as their daily cumulative dose.

  9. Daily cumulative dose of relevant medication [ Time Frame: Up to 24 hours ]
    The daily cumulative dose of sedatives, analgesics, antipsychotics, vasopressors and inotropes during the day of analysis will be documented,

  10. Mobilization [ Time Frame: Up to 24 hours ]
    The type of mobilization measures that a patient received on the day of analysis will be documented, ranging from passive in-bed mobilization, to active mobilization in-bed or sitting, to ambulation.

  11. Relevant non-pharmacologic measures [ Time Frame: Up to 24 hours ]
    The occurrence of non-pharmacologic measures to treat and/or prevent delirium during the patient's ICU stay will be documented. Options include: noise-reduction, light therapy, and also a free-text option to add other modalities.

  12. Family involvement [ Time Frame: Up to 24 hours ]
    Occurrence of caregiver and/or family talks during the patient's ICU stay will be documented.

  13. Sedation score [ Time Frame: Up to 24 hours ]
    The type of sedation screening and the patient's score on the day of analysis will be documented. The Richmond Agitation Sedation Scale measures a patient's state of sedation on a scale from -5 (not arousable) to +4 (agitated, combative), with 0 implying an awake and calm patient.

  14. Pain assessment type on day of analysis [ Time Frame: Up to 24 hours ]

    The type of pain assessment tool and the patient's score on the day of analysis will be documented.

    Different centers might used different tools to assess patient's pain level. This item asks each center to name the scoring tool used for the patient.


  15. Pain screening score on day of analysis [ Time Frame: Up to 24 hours ]

    The the patient's pain screening score on the day of analysis will be documented.

    The achievable score depends on the screening instrument used in the participating centers.



Other Outcome Measures:
  1. Acute Physiology And Chronic Health Evaluation (APACHE II) - Score [ Time Frame: At the beginning of the investigation ]
    The Acute Physiology And Chronic Health Evaluation (APACHE II) score is a classification system for disease severity for ICU patients. The score is calculated using 12 measurements from routine ICU patient management, as well as the patient's age. The scores range from 0-71, with higher scores corresponding to higher disease severity and mortality risk.

  2. Sequential Organ Failure Assessment (SOFA) - Score [ Time Frame: At the beginning of the investigation ]

    The Sequential Organ Failure Assessment score (SOFA) is a tool commonly used in the ICU to assess the patient's risk for morbidity and mortality. It contains 6 values from routine ICU management, each being scored on a scale from 0-4.

    Thus, a patient can have SOFA scores ranging from 0 to 24, with higher scores corresponding to higher risk.


  3. Age [ Time Frame: At the beginning of the investigation ]
  4. Gender [ Time Frame: At the beginning of the investigation ]
  5. Height [ Time Frame: At the beginning of the investigation ]
  6. Weight [ Time Frame: At the beginning of the investigation ]
  7. Major comorbidities [ Time Frame: At the beginning of the investigation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Data on the management of ICU patients ≥18 years will be collected. Data of approximately 288 patients per point-prevalence analysis will be collected. As the main parameters in question concern the routine patient management, there will be no follow-up on individuals
Criteria

Inclusion criteria:

  • Patient treated in the intensive care unit
  • Age ≥18 years

Exclusion criteria:

  • Blindness
  • Deafness
  • Lack of relevant language skills to complete assessments

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): NCT03553719


Contacts
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Contact: Claudia Spies, MD, Prof. +49 30 450 55 10 01 claudia.spies@charite.de

Locations
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Germany
Univ. - Prof. Dr. med. Claudia Spies Recruiting
Berlin-Mitte, Berlin, Germany, 13353
Contact: Claudia Spies, MD, Prof.    +49 30 450 55 10 01    claudia.spies@charite.de   
Principal Investigator: Claudia Spies, MD, Prof.         
Sub-Investigator: Björn Weiß, MD         
Sub-Investigator: Max Rosenthal         
Sponsors and Collaborators
Charite University, Berlin, Germany
European Society of Intensive Care Medicine
Investigators
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Study Director: Claudia Spies, MD, Prof. Charite University, Berlin, Germany

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Responsible Party: Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK), Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03553719     History of Changes
Other Study ID Numbers: EuMAS
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 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
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders