The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cause classification of OHCA protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Out-Of-Hospital Cardiac Arrest focused on measuring Non-traumatic Out-Of-Hospital Cardiac Arrest, training program
Eligibility Criteria
Inclusion Criteria: Residents of National Taiwan University Hospital Exclusion Criteria: Visiting staffs of National Taiwan University Hospital
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cause classification of OHCA protocol
Arm Description
The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants.
Outcomes
Primary Outcome Measures
diagnostic consistency between protocolized diagnosis and the discharge diagnosis
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
diagnostic consistency between protocolized diagnosis and the expert diagnosis
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
Secondary Outcome Measures
Portion of sufficient confidence to make proper OHCA cause identification
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. Confidence level more than 50% was recognized as sufficient to make proper cause identification. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
the accuracy rates on the classification test of OHCA cause before and after the lecture
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The knowledge for OHCA classification was evaluated by the accuracy rates on each questionnaires. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
diagnostic consistency between participants before and after the lecture
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively. The Light's kappa was used to evaluate the consistency of OHCA classification.
Full Information
NCT ID
NCT06012838
First Posted
August 8, 2023
Last Updated
August 23, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06012838
Brief Title
The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
Official Title
The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors. Identifying and treating the cause of cardiac arrest constitute a critical part in post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge, especially for unexperienced physicians. This study aims to evaluate whether a standardized protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA) patients.
Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in this study. The cause classification of OHCA (CCCA) protocol was developed by an expert cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained and compared to evaluate participants' learning effectiveness. To validate the efficiency of protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and ICU admission were reviewed retrospectively, and the OHCA cause of each patient was identified by the trained residents following CCCA protocol. The primary outcome was the diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge diagnosis
Detailed Description
To identify the classification of OHCA cause, the cause classification of OHCA (CCCA) protocol was established based on previous studies, expert physician's experience and questionnaire of young physicians.
Residents from emergency department of National Taiwan University Hospital participated the program and received the lecture concerning the Utstein's template, the epidemiology of cardiac arrest, interpretation of examinations, and the CCCA protocol. To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed, which included the knowledge for OHCA classification, confidence for correct diagnosis during CPR and after return of spontaneous circulation (ROSC), and the mandatory examinations for cause identification. Confidence level more than 50% was recognized as sufficient to make proper cause identification. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively.
To validate the efficiency of the CCCA protocol, these trained residents further identified the arrest cause of 586 non-traumatic adult OHCA patients who survived to ICU admission from January 2015 to July 2021 in NTUH following the established protocol.
The primary outcome was the consistency of OHCA cause between protocolized diagnosis, expert diagnosis and the discharge diagnosis. The diagnosis made by young physicians with protocol defined as protocolized diagnosis. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. Expert diagnosis was recognized as diagnosis identified by expert physician. The discharge diagnosis is the major diagnosis related to index cardiac arrest.
Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test. The continuous variables are presented as mean ± standard deviation. The Light's kappa was used to evaluate the consistency of OHCA classification. The value ≤ 0.40 indicates minimal agreement, while value ≥ 0.80 represent strong and almost perfect consistency16-17. The statistical significance was set at p <0.05. All statistical analyses were performed using Statistical Package for Social Sciences Statistics (version 21.0; IBM, Chicago, IL, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
Non-traumatic Out-Of-Hospital Cardiac Arrest, training program
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cause classification of OHCA protocol
Arm Type
Experimental
Arm Description
The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants.
Intervention Type
Behavioral
Intervention Name(s)
Cause classification of OHCA protocol
Intervention Description
training program with cause classification of OHCA protocol
Primary Outcome Measure Information:
Title
diagnostic consistency between protocolized diagnosis and the discharge diagnosis
Description
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
Time Frame
3 months
Title
diagnostic consistency between protocolized diagnosis and the expert diagnosis
Description
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Portion of sufficient confidence to make proper OHCA cause identification
Description
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. Confidence level more than 50% was recognized as sufficient to make proper cause identification. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
Time Frame
2 months
Title
the accuracy rates on the classification test of OHCA cause before and after the lecture
Description
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The knowledge for OHCA classification was evaluated by the accuracy rates on each questionnaires. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
Time Frame
baseline, 2 weeks
Title
diagnostic consistency between participants before and after the lecture
Description
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively. The Light's kappa was used to evaluate the consistency of OHCA classification.
Time Frame
baseline, 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Residents of National Taiwan University Hospital
Exclusion Criteria:
Visiting staffs of National Taiwan University Hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Shan Tsai, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei county
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
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