Enhancing European Management of Analgesia, Sedation and Delirium

NCT ID: NCT03553719

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2020-05-31

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".

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

One day point-prevalence analysis 1

Data on the management of intensive care unit patients ≥18 years will be collected. Data of approximately 170 patients per point-prevalence analysis will be collected.

No interventions assigned to this group

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 170 patients per point-prevalence analysis will be collected.

No interventions assigned to this group

One day point-prevalence analysis 3

Data on the management of intensive care unit patients ≥18 years will be collected. Data of approximately 170 patients per point-prevalence analysis will be collected.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Intensive Care Medicine

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Univ. - Prof. Dr. med. Claudia Spies

Mitte, State of Berlin, Germany

Countries

Germany

References

Paul N, Grunow JJ, Rosenthal M, Spies CD, Page VJ, Hanison J, Patel B, Rosenberg A, von Haken R, Pietsch U, Schrag C, Waydhas C, Schellongowski P, Lobmeyr E, Sander M, Piper SK, Conway D, Totzeck A, Weiss B. Enhancing European Management of Analgesia, Sedation, and Delirium: A Multinational, Prospective, Interventional Before-After Trial. Neurocrit Care. 2024 Jun;40(3):898-908. doi: 10.1007/s12028-023-01837-8. Epub 2023 Sep 11.

Reference Type: DERIVED

PMID: 37697129 (View on PubMed)

Other Identifiers

EuMAS

Identifier Type: -

Identifier Source: org_study_id