NCT05384613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

May 17, 2022

Last Update Submit

February 12, 2025

Conditions

Keywords

Sedation

Outcome Measures

Primary Outcomes (1)

  • 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

    01.01.2012- 31.12.2021

Secondary Outcomes (2)

  • Comorbidity scores

    01.01.2012- 31.12.2021

  • Outcome indicators

    01.01.2012- 31.12.2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Age ≥ 18 years

You may not qualify if:

  • Incomplete electronic records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - University Medicine Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DeliriumPain

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

May 12, 2022

Primary Completion

January 16, 2023

Study Completion

August 1, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations