Enhancing European Management of Analgesia, Sedation and Delirium

Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553719
• Other study ID #: EuMAS
• Status: Completed
• Start date: October 23, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Univ. - Prof. Dr. med. Claudia Spies	Berlin-Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Physiology And Chronic Health Evaluation (APACHE II) - Score	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.	At the beginning of the investigation
Other	Sequential Organ Failure Assessment (SOFA) - Score	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.	At the beginning of the investigation
Other	Age		At the beginning of the investigation
Other	Gender		At the beginning of the investigation
Other	Height		At the beginning of the investigation
Other	Weight		At the beginning of the investigation
Other	Major comorbidities		At the beginning of the investigation
Primary	Delirium screening rate	The delirium screening rate is documented and calculated according to patients´ records.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	Confusion assessment method for the intensive care unit (CAM-ICU)	CAM-ICU form patient records	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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,	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	Family involvement	Occurrence of caregiver and/or family talks during the patient's ICU stay will be documented.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours
Secondary	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.	Up to 24 hours