End-of-life Practices in 2019 vs. 2014

NCT04078815 | Completed DMC

• 1 other identifier: 447-29-7-2019
• Study Type: observational
• Target: 84
• Locations: 2 countries
• Sites: 2

Brief Summary

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 "experts" 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 "low" (i.e. below-average) domain A to D scores for 2014.

Conditions

Terminal Illness; Heart Arrest; Ethics, Narrative

Keywords

Advance Directive; Advance Care Planning; Decision Making; Autonomy; Justice; Emergency Care; Beneficence; Nonmaleficence; Dignity; Honesty

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• Organ donation

  Is organ donation allowed? Is heart beating or non-heart beating organ donation applied?

  Within 24 hours of surgical harvesting of organs

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare Providers with recognized clinical and/or scientific contribution in the field of resuscitation.

You may qualify if:

• 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.

You may not qualify if:

• No consent to participate

Sponsors & Collaborators

• University of Athens: lead

Study Sites (2)

University of Antwerp

Antwerp, Belgium

Location

Evaggelismos General Hospital

Athens, Attica, 10676, Greece

Location

Related Publications (17)

• 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. No abstract available.

  PMID: 26477419 BACKGROUND

• 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. doi: 10.1097/CCM.0000000000002169.

  PMID: 27984278 BACKGROUND

• Yarnell CJ, Fu L, Manuel D, Tanuseputro P, Stukel T, Pinto R, Scales DC, Laupacis A, Fowler RA. Association Between Immigrant Status and End-of-Life Care in Ontario, Canada. JAMA. 2017 Oct 17;318(15):1479-1488. doi: 10.1001/jama.2017.14418.

  PMID: 28973088 BACKGROUND

• 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.

  PMID: 26509317 BACKGROUND

• 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.

  PMID: 24598477 BACKGROUND

• Caplan GA, Meller A, Squires B, Chan S, Willett W. Advance care planning and hospital in the nursing home. Age Ageing. 2006 Nov;35(6):581-5. doi: 10.1093/ageing/afl063. Epub 2006 Jun 28.

  PMID: 16807309 BACKGROUND

• Chan HY, Pang SM. Let me talk--an advance care planning programme for frail nursing home residents. J Clin Nurs. 2010 Nov;19(21-22):3073-84. doi: 10.1111/j.1365-2702.2010.03353.x.

  PMID: 21040013 BACKGROUND

• Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.

  PMID: 20332506 BACKGROUND

• 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.

  PMID: 22458336 BACKGROUND

• 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.

  PMID: 27358437 BACKGROUND

• Tolle SW, Teno JM. Lessons from Oregon in Embracing Complexity in End-of-Life Care. N Engl J Med. 2017 Mar 16;376(11):1078-1082. doi: 10.1056/NEJMsb1612511. No abstract available.

  PMID: 28296604 BACKGROUND

• 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.

  PMID: 28246084 BACKGROUND

• Sulmasy DP. Italy's New Advance Directive Law: When in Rome.... JAMA Intern Med. 2018 May 1;178(5):607-608. doi: 10.1001/jamainternmed.2018.0462. No abstract available.

  PMID: 29532049 BACKGROUND

• Schulz-Quach C, Wenzel-Meyburg U, Fetz K. Can elearning be used to teach palliative care? - medical students' acceptance, knowledge, and self-estimation of competence in palliative care after elearning. BMC Med Educ. 2018 Apr 27;18(1):82. doi: 10.1186/s12909-018-1186-2.

  PMID: 29699593 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Sandelowski M, Voils CI, Knafl G. On Quantitizing. J Mix Methods Res. 2009 Jul 1;3(3):208-222. doi: 10.1177/1558689809334210.

  PMID: 19865603 BACKGROUND

• 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: 10.1016/j.resuscitation.2015.12.010. Epub 2016 Jan 14.

  PMID: 26776899 RESULT

MeSH Terms

Conditions

Heart Arrest; Narration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Communication; Behavior

Study Officials

• Leo Bossaert, MD, PHD, Professor

  Universiteit Antwerpen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Medicine

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 6, 2019
• Study Start: September 3, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); BE (1)