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Perception of Inappropriate CPR: a Multicenter International Cross-sectional Survey (REAppropriate)

16 maj 2018 uppdaterad av: University Hospital, Ghent

The REAppropriate Study: Perception of Inappropriate CPR: a Multicenter International Cross-sectional Survey

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 his/her 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 and/or 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 HCP's like moral distress and intentional job leave will be assessed.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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 and/or 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 Technicians/Nurse Assistants and Emergency Medical Technicians(EMT)/Paramedics 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, EMTs/Paramedics 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 (in)appropriate 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 (in)appropriateness 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 Brislin's 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 his/her 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.

Studietyp

Observationell

Inskrivning (Faktisk)

5882

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Brussels, Belgien, 1020
        • UVC Brugmann
      • Brussels, Belgien, 1000
        • UMC Sint-Pieter
      • Haine-Saint-Paul, Belgien, 7100
        • Groupe Jolimont
      • La Louvière, Belgien, 7100
        • CHU Tivoli
      • Montigny Le Tilleul, Belgien, 6110
        • CHU Vesale Charleroi

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The survey will focus on Healthcare Providers (HCPs) directly involved in treatment of cardiac arrest patients (out-of-hospital or in the Emergency Department (ED)): nurses, doctors, ED Technicians/Nurse Assistants and Emergency Medical Technicians(EMT)/Paramedics 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.

Beskrivning

Inclusion Criteria:

  • Healthcare Provider working in Emergency Department or Ambulance Service directly involved in treatment of cardiac arrest patients

Exclusion Criteria:

  • Healthcare Provider working in Emergency Department or Ambulance Service not directly involved in treatment of cardiac arrest patients

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
EMS Healthcare Providers
Healthcare Providers working in Emergency Medical Services and directly involved in treatment of cardiac arrest patients (out-of-hospital or in the Emergency Department)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The number of Healthcare Providers (HCPs) reporting Perceived Inappropriateness of CPR (PICPR) in the last cardiac arrest situation attended divided by the total number of surveyed HCPs
Tidsram: 2 weeks
2 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Moral distress and intentional job leave associated with Perceived Inappropriateness of CPR (PICPR)
Tidsram: 2 weeks
Moral distress defined as when one knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action
2 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Patrick M Druwé, MD, University Hospital, Ghent

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2015

Primärt slutförande (Faktisk)

1 november 2015

Avslutad studie (Faktisk)

1 november 2015

Studieregistreringsdatum

Först inskickad

14 januari 2015

Först inskickad som uppfyllde QC-kriterierna

30 januari 2015

Första postat (Uppskatta)

5 februari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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