Quality of Care in Centers Providing Extracorporeal Membrane Oxygenation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Cardiac Arrest; Cardiogenic Shock; Extracorporeal Circulation; Complications

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tharusan Thevathasan, MD; Phone Number: +4915774407864; Email: tharusan.thevathasan@charite.de
• Study Contact Backup: Name: Carsten Skurk, MD; Phone Number: +4930450513702; Email: carsten.skurk@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Permament adult staff which is employed in a cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO). Medical doctors and nurses are included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Medical doctors; Medical doctors who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation.
Nurses; Nurses who are employed as permanent staff in a cardiac arrest center which provides extracorporeal membrane oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Tharusan Thevathasan, MD, Charite University; Study Director: Carsten Skurk, MD, Charite University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: ECMO Quality of Care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No