Coaching Doctors and Nurses to Improve Ethical Decision-making in Team

Официальное название

Coaching Doctors and Nurses to Improve Ethical Decision-making in Team: a Stepped Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital

Обзор

Literature and a pilot study performed in 2019 indicate room for enhancing openness to discuss ethical sensitive issues within and between teams, and improving goal-oriented care and decision-making for the benefit of the patient at end-of-life, worldwide and more specifically in Belgium and in the Ghent University Hospital. The CODE study intervention performed in 2021 suggests already an improvement in goal oriented care operationalized via written Do-Not-Intubate and Do-Not-Attempt Cardio-Pulmonary Resuscitation (DNI-DNACPR orders in the Ghent University Hospital. In this study, the investigators found a nearly doubling of the incidence in written DNI-DNACPR in patient potentially receiving excessive treatment (PET) (from 19.7% to 29.7%, p\<0.001) and in patients hospitalized for the first time (from 1.9% to 3.4%, p=0.011) without increasing one-year mortality, after coaching doctors during 4 months in self-reflective and empowering leadership, and coping with group dynamics. However, the investigators found no improvement in the perception of the quality of the ethical climate by clinicians, more specifically by nurses. Despite the fact that ethical decision-making is considered a strategic priority in the Ghent University Hospital and an intense communication campaign, clinicians identified also a much smaller number of PET during this interventional study than during the observational pilot study in 2019. Although fading attention for the study over time and visibility of the electronic CODE alert to identify PET was claimed as the main reasons by 75% and 50.7% of the nurses, respectively, 95% expressed the desire to keep on using this alert in the future. This underscores a deeper concern in nurses. More than 40% expressed fear of blaming doctors or skepticism regarding the impact of identifying PET. Nonetheless, 35% acknowledged improvement in interdisciplinary meetings about end-of-life issues since study initiation. These findings highlights the need to additionally coach the entire team in future studies. Indeed, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires both, specific self-reflective and empowering leadership skills in doctors and head nurses (including the management of group dynamics in the interdisciplinary team), and confidence in speaking up in nurses and other health care professionals. This is what the investigators want to develop with this intervention. These skills will also help clinicians during patient and family meetings which will enable clinicians to better take into account the patient's and family's wishes.

Подробное описание

See protocol

Вмешательства

• Другое Usual Care Group
  The control group will receive usual care in which the quality of the ethical decision-making is determined by the clinical team according to their usual pratice. Except from a treatment-limitation-decisions guideline which focuses on the legal and deontological framework, no other guideline with regard to ethical decision-making has been implemented at the Ghent University Hospital.
• Поведенческое CODE II intervention
  1\) One interactive session of two hours focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, empowering leadership and the importance of "speaking up" within the team. 2) Every clinician will be invited to provide perceptions of excessive treatment via the electronic patient file. Once a patient is identified by two or more different clinicians, an email will be sent to coaches and the clinicians in charge o

Первичные конечные точки

• Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay [Срок оценки: At the end of the 14 months study period]
• Ethical decision-making climate questionnaire (EDMCQ) [Срок оценки: at the start and the end of the 14 month study period]

Вторичные конечные точки (12)

• Hospital Consumer Assessment of Healthcare Providers and Systems instrument [Срок оценки: 3 weeks after the patient's hospital discharge]
• Sinclair Compassion Questionnaire-Short Form (SCQ-SF) [Срок оценки: 3 weeks after the patient's hospital discharge]
• Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score [Срок оценки: 3 weeks after the patient's hospital discharge]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 3 weeks after hospital discharge]
• European quality of dying and death family questionnaire (Euro-QODD) [Срок оценки: 3 weeks after the patient's hospital discharge]
• Pain according to the Numeral Rating scale (NRS) : sum of the average daily score up to the end of the first hospital stay [Срок оценки: at the end of the 14 month study period]
• Pain according to the Numeral Rating Scale (NRS) : number of days with an average score > 3 up to the end of the first hospital stay [Срок оценки: at the end of the 14 month study period]
• Incidence of death up to one year after first hospital admission [Срок оценки: 12 months after first hospital admission]
• Percentage of patients who achieved the combined one year outcome (dead, not at home or utility <0.5 according to the European Quality-of-life 5 dimension instrument(Euro-QOL-5D)) [Срок оценки: 12 months after first hospital admission]
• Potentially inappropriate or burdensome treatments : incidence of achieving the combined patient burdensome treatments outcome (achieving outcome 13,14,15,16,17,18 or 19) up to one year after the first hospitalisation [Срок оценки: At the end of the 14 months study period]
• Potentially inappropriate or burdensome treatments : incidence of receiving cardio-pulmonary resuscitation up to one year after the first hospitalisation [Срок оценки: at the end of the 14 months study period]
• Potentially inappropriate or burdensome treatments : incidence of admission in the intensive care unit up to one year after the first hospitalisation [Срок оценки: At the end of the 14 month study period]

Критерии участия

Критерии включения

• Patients potentially receiving excessive treatment (PET) who are identified by clinicians during their first hospitalization. PET is defined as a patient in whom 2 or more clinicians doubt whether the treatment or treatment limitation code is consistent with their expected survival or quality of life (= "too much" or "excessive treatment") or whether the treatment limitation code is in line with the patient's or relatives' goals.
• Family members of PET
• Junior and senior doctors (including Department Heads) taking care of hospitalized patients
• Nurses (including head nurses) taking care of hospitalized patients
• Allied health professionals (psychologists, physical therapists, speech therapists, occupational therapists, social workers, spiritual care providers) taking care of hospitalized patients
• PET admitted / clinicians working in the 10 participating departments of of the Ghent University Hospital (Cardiology, Gastro-enterology and Hepatology, General Internal Medicine, Geriatrics, Hematology, Medical Oncology, Neurology, Nephrology (including dialysis unit), Pulmonology and the Medical ICU)

Критерии исключения

• PET with a previous written DNI-DNACPR order
• Patients and family members of PET who are less than 18 years old and persons who cannot understand Ducth questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 1 центр

• Ghent University Hospital — Ghent

Публикации

• Gerritsen RT, Koopmans M, Hofhuis JG, Curtis JR, Jensen HI, Zijlstra JG, Engelberg RA, Spronk PE. Comparing Quality of Dying and Death Perceived by Family Members and Nurses for Patients Dying in US and Dutch ICUs. Chest. 2017 Feb;151(2):298-307. doi: 10.1016/j.chest.2016.09.003. Epub 2016 Sep 19. PMID 27660153
• Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382. PMID 9089829
• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4. PMID 6226917
• Jensen HI, Gerritsen RT, Koopmans M, Downey L, Engelberg RA, Curtis JR, Spronk PE, Zijlstra JG, Ording H. Satisfaction with quality of ICU care for patients and families: the euroQ2 project. Crit Care. 2017 Sep 7;21(1):239. doi: 10.1186/s13054-017-1826-7. PMID 28882192
• Sinclair S, Kondejewski J, Hack TF, Boss HCD, MacInnis CC. What is the Most Valid and Reliable Compassion Measure in Healthcare? An Updated Comprehensive and Critical Review. Patient. 2022 Jul;15(4):399-421. doi: 10.1007/s40271-022-00571-1. Epub 2022 Feb 2. PMID 35107822
• US Department of Health and Human Services. Hospital compare quality of care. 2011. www.hospitalcompare.hhs.gov
• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087. PMID 11491192
• Benoit DD, De Pauw A, Jacobs C, Moors I, Offner F, Velghe A, Van Den Noortgate N, Depuydt P, Druwe P, Hemelsoet D, Meurs A, Malotaux J, Van Biesen W, Verbeke F, Derom E, Stevens D, De Pauw M, Tromp F, Van Vlierberghe H, Callebout E, Goethals K, Lievrouw A, Liu L, Manesse F, Vanheule S, Piers R. Coaching doctors to improve ethical decision-making in adult hospitalized patients potentially receiving PMID 39230678

Идентификаторы

NCT: NCT07327450 · ONZ-2025-0602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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