Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators

Pain Clinical Trial

Official title:

Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384613
• Other study ID #: ECOPAD
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

Exclusion Criteria:

• Incomplete electronic records

Related Conditions & MeSH terms

• Delirium
• Pain

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comorbidity scores	(Comorbidity scores are assessed according to Charlson comorbidity index (CCI) employing routine data, like icd-10 codes.	01.01.2012- 31.12.2021
Secondary	Outcome indicators	Outcome indicators from routine data are e. g. 30-day readmission rate, mortality, infection rate, length of stay, etc. )	01.01.2012- 31.12.2021