DeliriumNCT05384613
Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
An observational study of Delirium and Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 20,220 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2022to 1 Aug 2024
- 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: Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Dep. for Anesthesiology with focus on operative intensive care, CCM/CVK) from 01.01.2012- 31.12.2021
Who may be able to join
- Age ≥ 18 years
Who cannot join
- Incomplete electronic records
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.
Read the detailed description
The evaluation of quality-related process indicators (in this case, Quality Indicator II of the Intensive Care Quality Indicators of the DIVI*: Management of Analgesia, Sedation and Delirium) will be correlated with economic parameters of the treatment from economic data (DRG revenue, case costs). Data from clinical routine care from the Charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. In addition, further routine data, which may represent influencing factors like comorbidities (Charlson Comorbitity Index) are calculated using the ICD-10 coding. Also procedures using the OPS system are evaluated.
In this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. The analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers.
(* DIVI: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin = German Interdisciplinary Association for Intensive Care and Emergency Medicine)
- Keywords
- Sedation
- Medical subject headings
- Delirium, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of compliance to a quality indicator (Monitoring sedation, analgesia, delirium)
Influence of compliance to a quality indicator (Quality Indicator II of the DIVI; Management of Analgesia, Sedation and Delirium) and the relationship to case specific revenues and case costs according to case-specific analysis based on hospital financial data
Measured: 01.01.2012- 31.12.2021
Secondary outcomes (2)
Comorbidity scores
(Comorbidity scores are assessed according to Charlson comorbidity index (CCI) employing routine data, like icd-10 codes.
Measured: 01.01.2012- 31.12.2021
Outcome indicators
Outcome indicators from routine data are e. g. 30-day readmission rate, mortality, infection rate, length of stay, etc. )
Measured: 01.01.2012- 31.12.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 May 2022
- Primary completion16 Jan 2023
- Study completion1 Aug 2024
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
- Retrospective
- Enrolment
- 20,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384613
- Sponsor's protocol ID
- ECOPAD
- Status last verified
- Feb 2025
- First submitted
- 17 May 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuber A, Rubarth K, Forster F, Balzer F, Spies C, Furstenau D, Kumpf O. The impact of adhering to a quality indicator for sedation, analgesia, and delirium management on costs, revenues, and clinical outcomes in intensive care in Germany: A retrospective observational study. PLoS One. 2024 Aug 15;19(8):e0308948. doi: 10.1371/journal.pone.0308948. eCollection 2024.
PubMed 39146321
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
- ClinicalTrials.gov ID
- NCT05384613
- Acronym / sponsor ID
- ECOPAD
- Keywords
- Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,220 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 May 2022 (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.
Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.
Detailed description
The evaluation of quality-related process indicators (in this case, Quality Indicator II of the Intensive Care Quality Indicators of the DIVI*: Management of Analgesia, Sedation and Delirium) will be correlated with economic parameters of the treatment from economic data (DRG revenue, case costs). Data from clinical routine care from the Charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. In addition, further routine data, which may represent influencing factors like comorbidities (Charlson Comorbitity Index) are calculated using the ICD-10 coding. Also procedures using the OPS system are evaluated.
In this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. The analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers.
(* DIVI: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin = German Interdisciplinary Association for Intensive Care and Emergency Medicine)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Dep. for Anesthesiology with focus on operative intensive care, CCM/CVK) from 01.01.2012- 31.12.2021
Key inclusion criteria (1 listed)
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Incomplete electronic records
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
Influence of compliance to a quality indicator (Monitoring sedation, analgesia, delirium)
Time frame: 01.01.2012- 31.12.2021
Influence of compliance to a quality indicator (Quality Indicator II of the DIVI; Management of Analgesia, Sedation and Delirium) and the relationship to case specific revenues and case costs according to case-specific analysis based on hospital financial data
2 secondary outcomes
Comorbidity scores
Time frame: 01.01.2012- 31.12.2021
Outcome indicators
Time frame: 01.01.2012- 31.12.2021
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 14 Feb 2025.
- Results publication: PubMed 39146321Zuber A, Rubarth K, Forster F, Balzer F, Spies C, Furstenau D, Kumpf O. The impact of adhering to a quality indicator for sedation, analgesia, and delirium management on costs, revenues, and clinical outcomes in intensive care in Germany: A retrospective observational study. PLoS One. 2024 Aug 15;19(8):e0308948. doi: 10.1371/journal.pone.0308948. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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. principal investigator
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 and Pain, 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 1 inclusion and 1 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 14 Feb 2025. 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?
Influence of compliance to a quality indicator (Monitoring sedation, analgesia, delirium) (time frame: 01.01.2012- 31.12.2021). 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 NCT05384613, 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 14 Feb 2025.