Clinical trial NCT03553719: Enhancing European Management of Analgesia, Sedation and Delirium
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2018-06-12
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data on the management of ICU patients ≥18 years will be collected. Data of approximately 170 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

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.

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".

Eligibility 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

Primary outcomes:
measure: Delirium screening rate
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Delirium screening rate
timeFrame: Up to 24 hours
measure: Delirium screening type - as documented in the patient chart
timeFrame: Up to 24 hours
measure: Delirium screening score - as documented in the patient chart
timeFrame: Up to 24 hours
measure: Confusion assessment method for the intensive care unit (CAM-ICU)
timeFrame: Up to 24 hours
measure: Confusion assessment method for the intensive care unit (CAM-ICU) scoring by trained expert
timeFrame: Up to 24 hours
measure: Extracorporeal organ support
timeFrame: Up to 24 hours
measure: Parameters of infection
timeFrame: Up to 24 hours
measure: Use of relevant medication
timeFrame: Up to 24 hours
measure: Daily cumulative dose of relevant medication
timeFrame: Up to 24 hours
measure: Mobilization
timeFrame: Up to 24 hours
measure: Relevant non-pharmacologic measures
timeFrame: Up to 24 hours
measure: Family involvement
timeFrame: Up to 24 hours
measure: Sedation score
timeFrame: Up to 24 hours
measure: Pain assessment type on day of analysis
timeFrame: Up to 24 hours
measure: Pain screening score on day of analysis
timeFrame: Up to 24 hours
Other outcomes:
measure: Acute Physiology And Chronic Health Evaluation (APACHE II) - Score
timeFrame: At the beginning of the investigation
measure: Sequential Organ Failure Assessment (SOFA) - Score
timeFrame: At the beginning of the investigation
measure: Age
timeFrame: At the beginning of the investigation
measure: Gender
timeFrame: At the beginning of the investigation
measure: Height
timeFrame: At the beginning of the investigation
measure: Weight
timeFrame: At the beginning of the investigation
measure: Major comorbidities
timeFrame: At the beginning of the investigation
Locations:
city: Berlin-Mitte
country: Germany
facility: Univ. - Prof. Dr. med. Claudia Spies
state: Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: