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Completed

NCT Number: NCT03553719

Enhancing European Management of Analgesia, Sedation and Delirium

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univ. - Prof. Dr. med. Claudia Spies

Mitte, State of Berlin, 13353, Germany

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Delirium screening rate

    Time frame: Up to 24 hours

    The delirium screening rate is documented and calculated according to patients´ records.

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • European Society of Intensive Care Medicine

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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