Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation

Myocardial Infarction Clinical Trial

Official title:

Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05331001
• Other study ID #: ECMO Quality of Care
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2022
• Source: Charite University, Berlin, Germany
• Contact: Tharusan Thevathasan, MD
• Phone: +4915774407864
• Email: tharusan.thevathasan[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. Diagnostic and therapeutic measures, such as the use of devices for extracorporeal life support, require highly specialized training and skills. Apart from extensive medical expertise, physicians and nurses may be exposed to exceptional levels of occupational stressors. Therefore, excellent medical, psychological and inter-personal training of the medical staff is essential to improve patient outcomes. Assessment of quality of care is important to provide continuous improvement in patient care and team performance. To the best of our knowledge, there is no study which examined the quality of care in cardiac arrest centers across key dimensions of quality of care. Therefore, we aim to assess a bundle of key dimensions, that is psychological strain (P), resource utilization (R), interaction (I) between doctoral and nursing staff, costs of care (C) and education (E) programs for staff (PRICE scheme). A cross-sectional study will be conducted with doctors and nurses, using a digital quesitonnaire that will cover the five dimensions of the PRICE scheme.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult medical doctors or nurses

• Permament staff in the cardiac arrest center

• Cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO)

Exclusion Criteria:

• No permanent employment in a cardiac arrest center

• Non-adult staff

• Not a medical doctor or nurse

• Cardiac arrest center that does not provide therapy with ECMO

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiogenic Shock
• Extracorporeal Circulation; Complications
• Infarction
• Myocardial Infarction
• Shock, Cardiogenic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological strain (P)	The psychologial strain of permanent staff in the cardiac arrest center will be assessed based on a standardized questionnaire.	During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Secondary	Ressource utilization (R)	The availability of material and non-material ressources and the extent of ressource utilization in the cardiac arrest center will be assessed based on a standardized questionnaire.	During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Secondary	Interaction (I)	The quality of inter-professional interactions between medical doctors and nurses in the cardiac arrest center will be assessed based on a standardized questionnaire.	During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Secondary	Costs (C) of care	The costs of care in the cardiac arrest center will be assessed based on a standardized questionnaire.	During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.
Secondary	Education (E) programs	The availability and quality of education programs in the cardiac arrest center will be assessed based on a standardized questionnaire.	During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.