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Over the last few decades the fast technical and medical progress poses a significant challenge to doctors, who are asked to find the right balance between life-prolonging and palliative care. Previous studies suggest that doctors (unconsciously) prefer to remain prognostically uncertain rather than to gather the information that is required to reduce uncertainty and to effectively timely take decisions in the team for the benefit of the patient. To obtain all that information, the doctor in charge of the patient needs to empower clinicians to speak up while guarantying a safe environment. However, creating a safe climate which enhances inter-professional shared decision-making for the benefit of the patient requires specific self-reflective and empowering leadership skills (including the management of group dynamics in the interdisciplinary team).
The aim of this study is to investigate whether coaching doctors in self-reflective and empowering leadership, and in the management of team dynamics with regard to adult hospitalized patients potentially receiving excessive treatment during 4 months 1) improves ethical decision-making (primary objective) and 2) reduces the burden on patients, relatives, clinicians and the society (secondary objective). The improvement in quality of ethical decision-making will be assessed objectively via the incidence of written do-not-intubate and -resuscitate orders (first primary endpoint) in patients potentially receiving excessive treatment and subjectively via the ethical decision-making climate questionnaire that will be filled out by the team (second primary endpoint). In line with the DISPROPRICUS study, patients potentially receiving excessive treatment will be defined as patients who are perceived as receiving excessive treatment by two or more different clinicians in charge of the patient. The probability of being alive, at home with a good quality of life one year after admission was only 7% in patients potentially receiving excessive treatment in this study. Therefore, perceptions of excessive treatment by two or more clinicians are used in this study as a signal to initiate (self-)reflection in team about the quality of care that is provided to the patient and whether the treatment is in balance with the medical condition of the patient and the patient's goal of care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care |
|
| The CODE intervention | Experimental | The CODE intervention consists of 4 items, of which individual coaching sessions of 1 hour. In total each doctor taking care of hospitalized patients will be able to receive maximum 16 individual coaching sessions during the 4 months intervention period (one weekly). Every doctor will be invited to participate to at least 8 coaching sessions, to be extended on request, during the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CODE intervention | Behavioral | The CODE intervention consists of 1) One interactive session of 2 to 3 hrs focusing on the concepts of medical-ethical decision-making, the psychological challenge of dealing with ethically sensitive medical topics, and empowering leadership. 2) Observation and debrief of the interdisciplinary meeting to enhance self-reflection on empowering leadership and managing group dynamics. 3) Individual coaching on the spot in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making about patients who are perceived to receive excessive treatment during the intervention period, and in absence of such patients, every item with regard to ethical decision-making that is important for the coachee. 4) During the intervention coaches and doctors in charge will be informed of the presence of a patient potentially receiving excessive treatment in their ward by an electronic alert. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Ethical decision-making climate questionnaire (EDMCQ) | Clinician specific endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean of zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher scores iindicate higher quality of ethical decision-making | at the start and end of the 12 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death one year after first hospital admission | Patient-specific endpoint | 12 months after first hospital admission |
| Percentage of patients who achieved the combined one year patient outcome (dead, not at home or utility <0.5 according to the European Quality-of-life 5 dimension instrument (Euro-QOL-5D). |
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Inclusion criteria
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Benoit, MD,PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23802514 | Background | Smith AK, White DB, Arnold RM. Uncertainty--the other side of prognosis. N Engl J Med. 2013 Jun 27;368(26):2448-50. doi: 10.1056/NEJMp1303295. No abstract available. | |
| 29475979 | Background | Van den Bulcke B, Piers R, Jensen HI, Malmgren J, Metaxa V, Reyners AK, Darmon M, Rusinova K, Talmor D, Meert AP, Cancelliere L, Zubek L, Maia P, Michalsen A, Decruyenaere J, Kompanje EJO, Azoulay E, Meganck R, Van de Sompel A, Vansteelandt S, Vlerick P, Vanheule S, Benoit DD. Ethical decision-making climate in the ICU: theoretical framework and validation of a self-assessment tool. BMJ Qual Saf. 2018 Oct;27(10):781-789. doi: 10.1136/bmjqs-2017-007390. Epub 2018 Feb 23. |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Sample size for this stepped wedge randomised controlled trial is listed for patients potentially receiving excessive treatment (n=1700) together with one of their relatives who will be identified by junior doctors (n=75) , senior doctors (n=75) and nurses (n= 600) working in 10 departments of the Ghent university hospital during a 12 months period. Junior and senior doctors working in each department will be coached in self-reflective and empowering leadership, and in managing group dynamics with regard to patients potentially receiving excessive treatment for whom they are in charge of during a 4 month period. The impact of the intervention on the quality of ethical decision-making will be assessed at the patient (n=1700), relatives (n=1700) and team level (n=750).
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Patients will be blinded to the 4 months intervention period in junior and senior doctors.
|
| Usual care | Other | 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 practice. 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. In one ward (geriatrics), there is a ongoing project in which a clinical nurse specialist stimulates and performes advance care planning conversations with patient and/or relatives at request of the team and who organizes debriefings when needed based on the ethical concerns of the nurses. |
|
Patient-specific endpoint |
| 12 months after first hospital admission |
| Number of days admitted in the hospital up the end of the first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of first hospital stay | Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain). | at the end of the 12 months study period |
| Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay | Patient-specific endpoint. Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain). | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of achieving the combined patient burdersome treatment endpoint (achieving outcome 9,10,11,12,13,14,15 or 16) up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay | Patient-specific endpoint | at the end of the 12 months study period |
| Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS) | Patient-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction | 3 weeks after hospital discharge |
| Hospital anxiety and depression scale (HADS) | Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe) | 3 weeks after hospital discharge |
| European quality of dying and death family questionnaire (Euro-QODD nurse) | Patient-specific endpoint filled out by nurses. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality | within 1 week after death |
| European quality of dying and death family questionnaire (Euro-QODD family) | Patient-specific endpoint filled out by the relatives. The investigators will use the single-item assessment of quality of dying and death of this score ranging from 0 to 10. Higher values indicate higher quality | 3 weeks after the patient's death |
| Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS) | Family-specific endpoint. The investigators will use the single-item assessment of satisfaction of this score ranging from 0 to 10. Higher values indicate higher satisfaction | 3 weeks after the patient's hospital discharge |
| Hospital anxiety and depression scale (HADS) | Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe) | 3 weeks after the patient's hospital discharge |
| Impact of events scale-revised (IES-R) | Family-specific endpoint. This score is interpreted as follows: Low risk (0-11), moderate risk (12-32), high risk (33 or higher) for post-traumatic stress disorder. | 3 weeks after the patient's death |
| Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment | Clinician-specific endpoint | at the end of the 12 month study period |
| Percentage of clinicians with intention of leaving their job | Clinician-specific endpoint | at the start and end of the 12 month study period |
| Percentage of clinicians with sick leave | Team-specific endpoint | at the start and end of the 12 month study period |
| Ethical pratice score | Team-specific endpoint. This scores consist of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges from 0 to 10 with higher scores indicating a higher degree of ethical pratice organization | at the start and end of the 12 month study period |
| Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay | Society-specific endpoint | at the end of the 12 months study period |
| Health-care utilization : total number of emergency department visits | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of hospital admissions | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of admissions in the intensive care unit | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of days in the hospital | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of days in the intensive care unit | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of dialyses | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of surgical procedures | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of chemotherapeutic treatments | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of radiotherapeutic treatments | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of blood analyses | Society-specific endpoint | 12 months after first hospital discharge |
| Health-care utilization : total number of radiological investigations | Society-specific endpoint | 12 months after first hospital discharge |
| 29808345 | Background | Benoit DD, Jensen HI, Malmgren J, Metaxa V, Reyners AK, Darmon M, Rusinova K, Talmor D, Meert AP, Cancelliere L, Zubek L, Maia P, Michalsen A, Vanheule S, Kompanje EJO, Decruyenaere J, Vandenberghe S, Vansteelandt S, Gadeyne B, Van den Bulcke B, Azoulay E, Piers RD; DISPROPRICUS study group of the Ethics Section of the European Society of Intensive Care Medicine. Outcome in patients perceived as receiving excessive care across different ethical climates: a prospective study in 68 intensive care units in Europe and the USA. Intensive Care Med. 2018 Jul;44(7):1039-1049. doi: 10.1007/s00134-018-5231-8. Epub 2018 May 28. |
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| 41359551 | Derived | Piers R, Dillen L, Goethals K, Lievrouw A, Versluys K, 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, Geboes K, Manesse F, Vanheule S, Benoit DD. Coaching doctors to improve ethical decision-making in adult hospitalized patients potentially receiving excessive treatment: Process evaluation study of the CODE intervention in doctors and nurses working in ten acute hospital wards. PLoS One. 2025 Dec 8;20(12):e0337801. doi: 10.1371/journal.pone.0337801. eCollection 2025. |
| 39230678 | Derived | 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 excessive treatment. The CODE stepped-wedge cluster randomized controlled trial. Intensive Care Med. 2024 Oct;50(10):1635-1646. doi: 10.1007/s00134-024-07588-0. Epub 2024 Sep 4. |