DeliriumNCT03553719
Enhancing European Management of Analgesia, Sedation and Delirium
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 430 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2018to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patient treated in the intensive care unit
- Age ≥18 years
Who cannot join
- Blindness
- Deafness
- Lack of relevant language skills to complete assessments
Trial locations and contacts
1 site in 1 country.
Germany1 site
Univ. - Prof. Dr. med. Claudia Spies
Mitte, State of Berlin, 13353
About this study
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
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.
Read more
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.
Read the 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
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium screening rate
The delirium screening rate is documented and calculated according to patients´ records.
Measured: Up to 24 hours
Secondary outcomes (15)
Delirium screening rate
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.
Measured: Up to 24 hours
Delirium screening type - as documented in the patient chart
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.
Measured: Up to 24 hours
Delirium screening score - as documented in the patient chart
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.
Measured: Up to 24 hours
Confusion assessment method for the intensive care unit (CAM-ICU)
CAM-ICU form patient records
Measured: Up to 24 hours
Confusion assessment method for the intensive care unit (CAM-ICU) scoring by trained expert
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.
Measured: Up to 24 hours
Extracorporeal organ support
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.
Measured: Up to 24 hours
Parameters of infection
The patient's sepsis status according to SIRS- as well as Sepsis-3-criteria on the day of analysis will be documented.
Measured: Up to 24 hours
Use of relevant medication
The use of sedatives, analgesics, antipsychotics, vasopressors and inotropes during the day of analysis will be documented, as well as their daily cumulative dose.
Measured: Up to 24 hours
Daily cumulative dose of relevant medication
The daily cumulative dose of sedatives, analgesics, antipsychotics, vasopressors and inotropes during the day of analysis will be documented,
Measured: Up to 24 hours
Mobilization
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.
Measured: Up to 24 hours
Relevant non-pharmacologic measures
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.
Measured: Up to 24 hours
Family involvement
Occurrence of caregiver and/or family talks during the patient's ICU stay will be documented.
Measured: Up to 24 hours
Sedation score
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.
Measured: Up to 24 hours
Pain assessment type on day of analysis
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.
Measured: Up to 24 hours
Pain screening score on day of analysis
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.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start23 Oct 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553719
- Sponsor's protocol ID
- EuMAS
- Status last verified
- Oct 2022
- First submitted
- 24 Apr 2018
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37697129
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03553719
- Acronym / sponsor ID
- EuMAS
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patient treated in the intensive care unit
- Age ≥18 years
Key exclusion criteria (3 listed)
- Blindness
- Deafness
- Lack of relevant language skills to complete assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium screening rate
Time frame: Up to 24 hours
The delirium screening rate is documented and calculated according to patients´ records.
15 secondary outcomes
Delirium screening rate
Time frame: Up to 24 hours
Delirium screening type - as documented in the patient chart
Time frame: Up to 24 hours
Delirium screening score - as documented in the patient chart
Time frame: Up to 24 hours
Confusion assessment method for the intensive care unit (CAM-ICU)
Time frame: Up to 24 hours
Confusion assessment method for the intensive care unit (CAM-ICU) scoring by trained expert
Time frame: Up to 24 hours
Extracorporeal organ support
Time frame: Up to 24 hours
Parameters of infection
Time frame: Up to 24 hours
Use of relevant medication
Time frame: Up to 24 hours
Daily cumulative dose of relevant medication
Time frame: Up to 24 hours
Mobilization
Time frame: Up to 24 hours
Relevant non-pharmacologic measures
Time frame: Up to 24 hours
Family involvement
Time frame: Up to 24 hours
Sedation score
Time frame: Up to 24 hours
Pain assessment type on day of analysis
Time frame: Up to 24 hours
Pain screening score on day of analysis
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 37697129Paul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium screening rate (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.