Heart Arrest Clinical Trial
Official title:
Evolution of European Ethical Resuscitation and End-of-Life Practices From 2014 to 2019: A Survey-based Comparative Evaluation
Verified date | March 2020 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In 2014, the authors conducted a survey of key opinion leaders on ethical resuscitation
practices in 31 European Countries. The authors administered a comprehensive questionnaire to
1-2 ʺexpertsʺ from each country; subjectivity-related bias could not be excluded; however,
the questionnaire was actually administered twice over a 6-month period to all participants,
in order to confirm results' reproducibility. The questionnaire spanned across the following
4 domains: A: ethical practices (41 questions); B: access to best available care (39
questions); C: death diagnosis and organ donation (22 questions); and D: emergency care
organization (40 questions). Accordingly, a 142-point scoring system of the responses of the
participants was developed. Country-specific scores varied widely [e.g. score range of 1-41
for the ethical practices (domain A), and of 9-32 for emergency care organization (domain
D)]. The authors also found a significant association between domain A and domain D scores
(r2 = 0.42, P < 0.001).
The results of the 2014 survey highlighted variability across European countries in their
approach to the ethics of resuscitation/end-of-life care. Results also indicated the presence
of substantial need for improvements in all the aforementioned domains of practice and
emergency care organization On the other hand, such evolution should be substantially
augmented and accelerated by the above-described combination of new guidelines, RCT-based
support of ACP, legislation / governmental policies, and educational activities.
With this study the authors undertake a methodologically improved version of the 2014 survey,
in order to test the following hypotheses: 1) compared to 2014, there may be significant
improvements in overall domain A to D scores for 2019, reflecting improved quality of ethical
practice in the field of resuscitation/end-of-life care; 2) such progress, may be more marked
in countries with ʺlowʺ (i.e. below-average) domain A to D scores for 2014.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria - ERC National Resuscitation Council Representative; and/or member of the EuReCa investigators network or other ERC related clinical research networks (such as EDICES, REAPPROPRIATE, NETSCAPE, EURO-CALL. - Established Researcher in the field: First, second, or last author of published scholarly articles in this field. - At least 3 years of prior service as Lead Clinician in Emergency /and/or Intensive Care. Exclusion Criteria • No consent to participate |
Country | Name | City | State |
---|---|---|---|
Belgium | University of Antwerp | Antwerp | |
Greece | Evaggelismos General Hospital | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Belgium, Greece,
Bossaert LL, Perkins GD, Askitopoulou H, Raffay VI, Greif R, Haywood KL, Mentzelopoulos SD, Nolan JP, Van de Voorde P, Xanthos TT; ethics of resuscitation and end-of-life decisions section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 11. The ethics of resuscitation and end-of-life decisions. Resuscitation. 2015 Oct;95:302-11. doi: 10.1016/j.resuscitation.2015.07.033. Epub 2015 Oct 15. — View Citation
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Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. Review. — View Citation
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El-Jawahri A, Paasche-Orlow MK, Matlock D, Stevenson LW, Lewis EF, Stewart G, Semigran M, Chang Y, Parks K, Walker-Corkery ES, Temel JS, Bohossian H, Ooi H, Mann E, Volandes AE. Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. Circulation. 2016 Jul 5;134(1):52-60. doi: 10.1161/CIRCULATIONAHA.116.021937. — View Citation
Fritz Z, Slowther AM, Perkins GD. Resuscitation policy should focus on the patient, not the decision. BMJ. 2017 Feb 28;356:j813. doi: 10.1136/bmj.j813. — View Citation
Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2. Review. — View Citation
Kirchhoff KT, Hammes BJ, Kehl KA, Briggs LA, Brown RL. Effect of a disease-specific advance care planning intervention on end-of-life care. J Am Geriatr Soc. 2012 May;60(5):946-50. doi: 10.1111/j.1532-5415.2012.03917.x. Epub 2012 Mar 28. — View Citation
Kon AA, Davidson JE, Morrison W, Danis M, White DB; American College of Critical Care Medicine; American Thoracic Society. Shared Decision Making in ICUs: An American College of Critical Care Medicine and American Thoracic Society Policy Statement. Crit Care Med. 2016 Jan;44(1):188-201. doi: 10.1097/CCM.0000000000001396. — View Citation
Mentzelopoulos SD, Bossaert L, Raffay V, Askitopoulou H, Perkins GD, Greif R, Haywood K, Van de Voorde P, Xanthos T. A survey of key opinion leaders on ethical resuscitation practices in 31 European Countries. Resuscitation. 2016 Mar;100:11-7. doi: 10.101 — View Citation
Sandelowski M, Voils CI, Knafl G. On Quantitizing. J Mix Methods Res. 2009 Jul 1;3(3):208-222. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | END-OF-LIFE PRACTICES | Do-not-attempt-Cardiopulmonary Resuscitation; Advance Directives; Advance Care Planning; Terminal Analgesia; Termination of Resuscitation; Treatment Limitation; Euthanasia; Resuscitation continuation in the prospect of higher-level treatment (e.g. extracorporeal membrane oxygenation) or organ donation | Within one year of occurrence of cardiac arrest or need for treatment of an acute illness | |
Primary | END-OF-LIFE DECISIONS | For both Adults and Children: Family participating in end-of-life decisions; End-of-life decisions are reached through processes of shared decision making | Within one year of occurrence of cardiac arrest or need for treatment of an acute illness | |
Primary | Family presence during Cardiopulmonary Resuscitation (CPR) | Adults: Family present during CPR; Children: Parents present during CPR? Adults / Children: Other family members present during CPR? | Wtihin 6 hours of onset of cardiac arrest | |
Primary | ACCESS TO BEST RESUSCITATION AND POSTRESUSCITATION CARE | Is access to best available care (including extracorporeal CPR wherever available) affected by age? race? religion? comorbidity? socioeconomic status? urban-rural (area of occurrence)? type of receiving hospital (out-of-hospital setting) or type of treating hospital (inhospital setting)? minority? language? high-risk presentation (e.g. Acute Physiology and Chronic Health Evaluation Score II score>25 corresponding to >50% mortality probability)? suicide attempt? knowledge of patient's wish against undergoing CPR? other? | Within 10 days of onset of cardiac arrest | |
Primary | DIAGNOSIS OF DEATH AND ORGAN DONATION | Who is legally allowed to diagnose death? Diagnostic criteria for death: Brain death criteria or Cardiorespiratory death criteria? | Within 60 min of cessation of resuscitaiton efforts | |
Primary | Organ donation | Is organ donation allowed? Is heart beating or non-heart beating organ donation applied? | Within 24 hours of surgical harvesting of organs | |
Primary | EMERGENCY CARE: Access to resuscitation care in case of cardiac arrest in different areas / settings | Availability of emergency numbers; ambulance arrival within 10 min in the out-of-hospital settings; resuscitation team arrival within 10 min in the inhospital setting | Within 60 min of onset of cardiac arrest | |
Primary | EMERGENCY CARE: Defibrillation | Who is legally allowed to defibrillate? Are automated external defibrillators (AEDs) available in ambulances? other emergency service vehicles? different kinds of public places? Are AED data available in patient record? Are there specific, ongoing, public-access AED programs (e.g home AED? school AED? in-hospital AED)? Are there AED registries? | Within 60 min of onset of cardiac arrest | |
Primary | EMERGENCY CARE: Level of care provided by out-of-hospital emergency services | Is there an alert system for lay rescuers? Is dispatcher assisted bystander cardiopulmonary resuscitation (CPR) practiced? Do ambulances offer basic life support and defibrillation, or advanced life support? is arrest resuscitation for traumatic cardiac arrest undertaken by specifically qualified personnel - are there specific criteria for withholding or terminating resuscitation? | Within 60 min of onset of cardiac arrest | |
Primary | Organization of in-hospital resuscitation services | Are in-hospital Rapid Response Teams in place?; Is cardiopulmonary resuscitation (CPR) feedback, debriefing, audit applied? Is CPR training on the recently dead allowed / applied? | Within 24 hours of onset of cardiac arrest | |
Primary | EMERGENCY CARE: Registry reporting of cardiac arrest | Is there registry reporting of out-of-hospital and in-hospital cardiac arrest data? | Within 24 hours of onset of cardiac arrest | |
Primary | EMERGENCY CARE: Education | Are there ongoing, theoretical and or practice training educational programs in the field of Ethics? Is certified cardiopulmonary resuscitation training mandatory for healthcare providers? | Within the preceding and subsequent 5-year period | |
Primary | EMERGENCY CARE: Enrollment in Emergency Research and Informed Consent | Is enrollment of adults in emergency observational or interventional (drug or non-drug) research legally allowed? | Within 4 hours of onset of cardiac arrest |
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