Enhancing European Management of Analgesia, Sedation and Delirium

NCT03553719 | Completed

• 1 other identifier: EuMAS
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium screening rate

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

  Up to 24 hours

Secondary Outcomes (15)

• Delirium screening rate

  Up to 24 hours

• Delirium screening type - as documented in the patient chart

  Up to 24 hours

• Delirium screening score - as documented in the patient chart

  Up to 24 hours

• Confusion assessment method for the intensive care unit (CAM-ICU)

  Up to 24 hours

• Confusion assessment method for the intensive care unit (CAM-ICU) scoring by trained expert

  Up to 24 hours

Other Outcomes (7)

• Acute Physiology And Chronic Health Evaluation (APACHE II) - Score

  At the beginning of the investigation

• Sequential Organ Failure Assessment (SOFA) - Score

  At the beginning of the investigation

• Age

  At the beginning of the investigation

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (1)

Univ. - Prof. Dr. med. Claudia Spies

Mitte, State of Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 37697129 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM/CVK)

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 12, 2018
• Study Start: October 23, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)