NCT05331001

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 10, 2022

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ressource utilization (R)

    During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.

  • Interaction (I)

    During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.

  • Costs (C) of care

    During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.

  • Education (E) programs

    During one week all permanent staff of a cardiac arrest center will be asked to fill out the standardized questionnaire.

Study Arms (2)

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.

Eligibility Criteria

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

You may qualify if:

  • Adult medical doctors or nurses
  • Permament staff in the cardiac arrest center
  • Cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ECMO)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, CardiogenicMyocardial InfarctionHeart Arrest

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Carsten Skurk, MD

    Charite University

    STUDY DIRECTOR
  • Tharusan Thevathasan, MD

    Charite University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 15, 2022

Study Start

June 1, 2022

Primary Completion

December 30, 2022

Study Completion

March 30, 2023

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share