Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02356029
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2015-01-14
Brief Title:
Perception of Inappropriate CPR a Multicenter International Cross-sectional Survey
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
The REAppropriate Study Perception of Inappropriate CPR a Multicenter International Cross-sectional Survey
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REAppropriate
Brief Summary:
The primary objective of this study is to determine how often cardiopulmonary resuscitation CPR is perceived as inappropriate by Healthcare Providers HCPs working in prehospital Ambulance Services and Emergency Departments Perception of inappropriate CPR is defined as resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the patient in terms of survival or quality of life
When a HCP perceives CPR as inappropriate this may cause moral and emotional distress This perception may be modulated by the personal background and professional role of the HCP but also by hisher working conditions Apart from the workload the resulting distress can be influenced by the way non-technical skills are developed within the team and the ethical environment in which the HCP functions Frequent exposure to similar patient care situations andor a professional environment not acknowledging the distress may lead to deficient coping mechanisms and accumulation of moral distress This may be associated with job leave burnout and a decreased quality of patient care Acute distress may also influence the quality of care provided to actual and future patients
Secondary objectives of the study are to evaluate whether perceived inappropriateness of CPR is not only associated with patient related factors but also with personal characteristics and work related factors Potential consequences for HCPs like moral distress and intentional job leave will be assessed
When a HCP perceives CPR as inappropriate this may cause moral and emotional distress This perception may be modulated by the personal background and professional role of the HCP but also by hisher working conditions Apart from the workload the resulting distress can be influenced by the way non-technical skills are developed within the team and the ethical environment in which the HCP functions Frequent exposure to similar patient care situations andor a professional environment not acknowledging the distress may lead to deficient coping mechanisms and accumulation of moral distress This may be associated with job leave burnout and a decreased quality of patient care Acute distress may also influence the quality of care provided to actual and future patients
Secondary objectives of the study are to evaluate whether perceived inappropriateness of CPR is not only associated with patient related factors but also with personal characteristics and work related factors Potential consequences for HCPs like moral distress and intentional job leave will be assessed
Detailed Description:
The REAppropriate study is an international multicentric cross-sectional survey exploring perception of inappropriateness of CPR
Objectives
The primary objective of this study is to determine the prevalence of perceived inappropriateness of CPR PICPR of the last resuscitation performed out-of-hospital or in the Emergency Department ED by Healthcare Providers HCP working in prehospital Ambulance Services and EDs PICPR is defined as resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the patient in terms of survival or quality of life Prevalence of PICPR is defined as the number of HCPs reporting PICPR in the last cardiac arrest situation they attended divided by the total number of surveyed HCPs
Secondary objectives are to evaluate the hypothesis that PICPR is not only associated with patient related factors but also with personal characteristics and work related factors Other objectives will be assessment of moral distress and intentional job leave
In each participating country a National Coordinator is nominated by the Steering Committee National Coordinators are selected because of their leading role in national or international scientific organisations related to Emergency Medicine andor their teaching or research activities related to Emergency Medicine
Each National Coordinator establishes a network of Local Investigators who coordinate study proceedings within EDs and Ambulance Services
Study population
The survey will focus on HCPs directly involved in treatment of cardiac arrest patients out-of-hospital or in the ED nurses doctors ED TechniciansNurse Assistants and Emergency Medical TechniciansEMTParamedics working in EDs and prehospital Ambulance Services active in the Emergency Medical Services system of the country Hospitals in countries without established EDs but with a group of HCPs working inside the hospital and having as their daily duty the first care and stabilisation of patients arriving unplanned in the hospital are also eligible for participation in the study The Local Investigator will clearly delineate this functional unit within the hospital thus determining the number of eligible HCPs within the center
Survey
Two electronic questionnaires will be used one for the Local Investigator of the ED or Ambulance Service and one for the HCPs
Questionnaire for Local Investigator this questionnaire requests quantitative data on organisational issues like number of beds ED or Ambulance Service activity number of doctors nurses EMTsParamedics etc and a few questions about resuscitation practice
Questionnaire for HCPs the HCPs are asked about their personal characteristics and educational background There are questions about their working conditions job strain and teamwork within their professional environment Their opinion is asked about possible reasons and statements concerning perception of inappropriate resuscitation Finally they are questioned about the last resuscitation they were involved in themselves it will not be necessary for them to have the medical file available while answering these questions The HCP is first asked an opinion about the inappropriateness of the intervention and the resulting amount of moral and emotional distress should this be the case This is followed by questions about the circumstances of the cardiac arrest and a query on the relative importance of patient related situational and interprofessional items Four level Likert items are used where appropriate Interest level analysis will be incorporated in the questionnaire to assist in assessing nonresponse bias
Completion of the questionnaire will take approximately 20 minutes Participation is on a voluntary basis
Translation of surveys
A modified Brislins model of translation will be used The primary questionnaires are in English Both questionnaires are being translated in additional languages the so called target languages using the following procedure
1 The first step will be forward translation of the English questionnaire into the target language by two native speakers of the target language with a proficient knowledge of English and ideally with a background in the medical specialties covered by the topic of this research
2 The second step is that a third person whose native language is the target language reviews the translated versions together with the translators of step 1 for grammatical style and comprehensibility without the English text so this can be a monolingual person The most appropriate forward translation is chosen
3 When this has been achieved the third step is the back translation to the English language of the most appropriate forward translation by two different bilingual persons ideally native English speaking with a proficient knowledge of the target language who are blinded from the original English version Again efforts are made that the back translators are professionally involved in the research field to improve the quality of the translation process The two back translations are reviewed with a third person and the most appropriate back translation is chosen
4 In the last and fourth step the Steering Committee compares the most appropriate back translation of both questionnaires with the original English version If necessary recommendations will be done for modifications
Throughout this process regular interaction and feedback with the Steering Committee will further optimise the quality of the translation
Information Technology
All the data will be collected through the use of a website especially designed for this study Normal web applications use HTTP Hypertext Transfer Protocol to transfer web pages between the web server and the web browser In order to guarantee data safety a HTTPS website signed by a trusted certificate authority will be used for this project All the transferred data are encrypted in these circumstances and can only be read by the web browser and the web server
Ethics approval
For the HCP no risk is associated with participation in the study since the survey is completely anonymous Insight in medical files is unnecessary to complete the questionnaires
The National Coordinator will submit the protocol to one or more national ethical committees according to the rules applied in hisher jurisdiction Ethical approvals should be sent to the Steering Committee
If necessary written informed consent will be obtained from the participating HCPs Otherwise completion of the questionnaire by the HCP will be taken as evidence of consent to study participation In countries where informed consent must be obtained it is preferable that the informed consent is uniform for the whole country
Centers are not allowed to retrieve and report data unless ethical approval or after reporting to the Steering Committee there is no requirement for ethical approval for their country
Objectives
The primary objective of this study is to determine the prevalence of perceived inappropriateness of CPR PICPR of the last resuscitation performed out-of-hospital or in the Emergency Department ED by Healthcare Providers HCP working in prehospital Ambulance Services and EDs PICPR is defined as resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the patient in terms of survival or quality of life Prevalence of PICPR is defined as the number of HCPs reporting PICPR in the last cardiac arrest situation they attended divided by the total number of surveyed HCPs
Secondary objectives are to evaluate the hypothesis that PICPR is not only associated with patient related factors but also with personal characteristics and work related factors Other objectives will be assessment of moral distress and intentional job leave
In each participating country a National Coordinator is nominated by the Steering Committee National Coordinators are selected because of their leading role in national or international scientific organisations related to Emergency Medicine andor their teaching or research activities related to Emergency Medicine
Each National Coordinator establishes a network of Local Investigators who coordinate study proceedings within EDs and Ambulance Services
Study population
The survey will focus on HCPs directly involved in treatment of cardiac arrest patients out-of-hospital or in the ED nurses doctors ED TechniciansNurse Assistants and Emergency Medical TechniciansEMTParamedics working in EDs and prehospital Ambulance Services active in the Emergency Medical Services system of the country Hospitals in countries without established EDs but with a group of HCPs working inside the hospital and having as their daily duty the first care and stabilisation of patients arriving unplanned in the hospital are also eligible for participation in the study The Local Investigator will clearly delineate this functional unit within the hospital thus determining the number of eligible HCPs within the center
Survey
Two electronic questionnaires will be used one for the Local Investigator of the ED or Ambulance Service and one for the HCPs
Questionnaire for Local Investigator this questionnaire requests quantitative data on organisational issues like number of beds ED or Ambulance Service activity number of doctors nurses EMTsParamedics etc and a few questions about resuscitation practice
Questionnaire for HCPs the HCPs are asked about their personal characteristics and educational background There are questions about their working conditions job strain and teamwork within their professional environment Their opinion is asked about possible reasons and statements concerning perception of inappropriate resuscitation Finally they are questioned about the last resuscitation they were involved in themselves it will not be necessary for them to have the medical file available while answering these questions The HCP is first asked an opinion about the inappropriateness of the intervention and the resulting amount of moral and emotional distress should this be the case This is followed by questions about the circumstances of the cardiac arrest and a query on the relative importance of patient related situational and interprofessional items Four level Likert items are used where appropriate Interest level analysis will be incorporated in the questionnaire to assist in assessing nonresponse bias
Completion of the questionnaire will take approximately 20 minutes Participation is on a voluntary basis
Translation of surveys
A modified Brislins model of translation will be used The primary questionnaires are in English Both questionnaires are being translated in additional languages the so called target languages using the following procedure
1 The first step will be forward translation of the English questionnaire into the target language by two native speakers of the target language with a proficient knowledge of English and ideally with a background in the medical specialties covered by the topic of this research
2 The second step is that a third person whose native language is the target language reviews the translated versions together with the translators of step 1 for grammatical style and comprehensibility without the English text so this can be a monolingual person The most appropriate forward translation is chosen
3 When this has been achieved the third step is the back translation to the English language of the most appropriate forward translation by two different bilingual persons ideally native English speaking with a proficient knowledge of the target language who are blinded from the original English version Again efforts are made that the back translators are professionally involved in the research field to improve the quality of the translation process The two back translations are reviewed with a third person and the most appropriate back translation is chosen
4 In the last and fourth step the Steering Committee compares the most appropriate back translation of both questionnaires with the original English version If necessary recommendations will be done for modifications
Throughout this process regular interaction and feedback with the Steering Committee will further optimise the quality of the translation
Information Technology
All the data will be collected through the use of a website especially designed for this study Normal web applications use HTTP Hypertext Transfer Protocol to transfer web pages between the web server and the web browser In order to guarantee data safety a HTTPS website signed by a trusted certificate authority will be used for this project All the transferred data are encrypted in these circumstances and can only be read by the web browser and the web server
Ethics approval
For the HCP no risk is associated with participation in the study since the survey is completely anonymous Insight in medical files is unnecessary to complete the questionnaires
The National Coordinator will submit the protocol to one or more national ethical committees according to the rules applied in hisher jurisdiction Ethical approvals should be sent to the Steering Committee
If necessary written informed consent will be obtained from the participating HCPs Otherwise completion of the questionnaire by the HCP will be taken as evidence of consent to study participation In countries where informed consent must be obtained it is preferable that the informed consent is uniform for the whole country
Centers are not allowed to retrieve and report data unless ethical approval or after reporting to the Steering Committee there is no requirement for ethical approval for their country
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None