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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.
See protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator |
| |
| CODE II intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care Group | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay | Patient-specific endpoint | At the end of the 14 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 indicate higher quality of interdisciplinary ethical decision-making | at the start and the end of the 14 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Consumer Assessment of Healthcare Providers and Systems instrument | Patient-specific endpoint. Patients rate the quality of their hospital stay on a scale of 0 (worst) to 10 (best) and indicate whether they would recommend their hospital to family and friends. | 3 weeks after the patient's hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Health-care utilization : total hospital cost by the hospital billing record up to one year after the first hospital admission | Society-level endpoint | 12 months after first hospital admission |
| Health-care utilization : total number of emergency department visits up to one year after the first hospital admission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Benoit, MD, PhD | Contact | +32 (9) 332 27 75 | dominique.benoit@uzgent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | East-Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27660153 | Background | 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. | |
| 9089829 | Background |
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In order to guaranty the entire safety of the participating departments and as such the change management trajectories of these departments, IPD will not be shared. Specific departments admit specific patient population : therefore, the quality of the ethical climate per department cannot be anonymized.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2026 |
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In total 50 to 75 junior doctors, 50 to 75 senior doctors (including medical head of department), 300 to 500 nurses (including head nurses) and 100 to 200 allied health professionals working in 10 departments of the Ghent University Hospital are eligible for this study and about 350 to 700 adult patients potentially receiving excessive treatment who did not yet receive a written DNI-DNACPR order together with one of their relatives. Stepped wedge cluster randomized trial in 10 hospital wards combined with pre- and post-measurement of the ethical climate.
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Patients will be blinded to the 4 months intervention period
|
| CODE II intervention | Behavioral | 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 of the PET during intervention period. 3) The 4 months coaching intervention will consist of : a. Doctors and head nurses : individual coaching sessions in self-reflective and empowering leadership and in managing groups dynamics with regard to ethical decision-making in team about PET patients. b. All clinicians : multidisciplinary coaching during work shift hand-overs and structured metareflective sessions on specific themes related to ethical decision-making in team about PET. |
|
| Sinclair Compassion Questionnaire-Short Form (SCQ-SF) |
Patient-specific endpoint. The SCQ is a validated instrument for quantifying compassion in healthcare from multiple perspectives (e.g., patients, family, clinicians). It studies outcomes valued by the patient such as 'feeling heard and understood by their clinician' and 'being valued as a person'. The Belgian version of the 5-item SCQ-SF (Sinclair Compassion Questionnaire-Short Form) is used with each item rating on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated as the mean of the five items, resulting in a theoretical range from 1 to 5. A higher SCQ score is indicative of higher compassionate care. |
| 3 weeks after the patient's hospital discharge |
| Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score | Patient-specific endpoint. Validated 18 item questionnaire covering satisfaction with 4 domains: communication, empathy, symptom management and decision-making. The investigators will use the single-item assessment of satisfaction of this score raning from 0 to 10. higher values indicate higher satisfaction. | 3 weeks after the patient's hospital discharge |
| Hospital Anxiety and Depression Scale (HADS) | Patient-specific endpoint. Validated 14-item self-report assessment with subscales for anxiety and depression. Each domain has a score range of 0-21 with the following interpretation: 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) | Patient-specific endpoint filled out by the relatives. Euro-QDDD family is a 14 item questionnaire to allow relatives to assess patients quality of dying and death. | 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 | Patient-specific endpoint; Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain) | 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 | Patient-specific endpoint. Single-item assessment of pain raging from 0 (no pain) to 10 (worst possible pain). | at the end of the 14 month study period |
| Incidence of death up to one year after first hospital admission | Patient-specific endpoint | 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)) | Patient-specific endpoint. Euro-QOL-5D measures health-related quality of life, with possibility of conversion of each health state in a utility index (range -0.1584 to 1.000). This questionnaire measures health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression | 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 | Patient-specific endpoint | 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 | Patient-specific endpoint | 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 | Patient-specific endpoint | At the end of the 14 month study period |
| Potentially inappropriate or burdensome treatments : incidence of receiving invasive mechanical ventilation up to one year after the first hospitalisation | Patient-specific endpoint | At the end of the 14 month study period |
| Potentially inappropriate or burdensome treatments : incidence of receiving dialysis up to one year after the first hospitalisation | Patient-specific endpoint | At the end of the 14 month study period |
| Potentially inappropriate or burdensome treatments : incidence of receiving a surgical procedure up to one year after the first hospitalisation | Patient-specific endpoint | At the end of the 14 month study period |
| Potentially inappropriate or burdensome treatments : incidence of receiving chemotherapy up to one year after the first hospitalisation | Patient-specific endpoint | At the end of the 14 month study period |
| Potentially inappropriate or burdensome treatments : incidence of receiving radiotherapy up to one year after the first hospitalisation | Patient-specific endpoint | At the end of the 14 months study period |
| Hospital Consumer Assessment of Healthcare Providers and Systems instrument | Family-specific endpoint. Family rate the quality of their hospital stay on a scale of 0 (worst) to 10 (best) and indicate whether they would recommend their hospital to family and friends. | 3 weeks after the patient's hospital discharge |
| Sinclair Compassion Questionnaire-Short Form (SCQ-SF) | Family-specific endpoint. The SCQ is a validated instrument for quantifying compassion in healthcare from multiple perspectives (e.g., patients, family, clinicians). It studies outcomes valued by the patient such as "feeling heard and understood by their clinicians" and "being valued as a person". The Belgian version of the 5-item SCQ-SF (Sinclair Compassion Questionnaire-Short Form) is used with each item rating on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated as the mean of the five items, resulting in a theoretical range from 1 to 5. A higher SCQ score is indicative of higher compassionate care. | 3 weeks after the patient's hospital discharge |
| Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score | Family-specific endpoint. Validated 18 item questionnaire covering satisfaction with 4 domains: communication, empathy, symptom management and decision-making. The investigators will use the single-item assessment of satisfaction of this score raning 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. Validated 14-item self-report assessment with subscales for anxiety and depression. Each domain has a score range of 0-21 with the following interpretation: 0-7 normal, 8-10 mild, 11-21 moderate to severe | 3 weeks after the patient's hospital discharge |
| Differences in EDMCQ between doctors and nurses | Clinician spefic endpoint. Factorscores on 7 domains, which is normally distributed, centred at mean zero, with standard deviation 5.5 (minimum score -25, maximum score 25). Higher difference in scores between doctors and nurses indicate a greater gap in the perception of the ethical climate between roles. | at the start and end of the 14 month study period |
| Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment | Clinician-specific endpoint | At the end of the 14 month study period |
| Percentage of clinicians with intention of leaving their job | Clinician-specific endpoint | At the start and end of the 14 month study period |
| Percentage of clinicians with sick leave | Team-specific endpoint | At the start and end of the 14 month study period |
| Ethical pratice score | Team-specific endpoint. This score consists of 12 items. The investigators will use the 10 department specific items (minus the 2 country-specific items). This score ranges between 0 to 10 with higher scores indicating a higher degree of ethical pratice organization | At the start and end of the 14 month study period |
| Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay in the overall patient population admitted in the participating wards | Patient-specific endpoint | At the end of the 14 months study period |
| Incidence of death up to one year after first hospital admission in the overall patient population admitted in the participating wards | Patient-specific endpoint | At the end of the 14 month study period |
| Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admission |
Society-specific endpoint |
| 12 months after first hospital admission |
| Health-care utilization : total number of hospitalizations up to one year after the first hospital admission | Society-specific endpoint | 12 months after first hospital admission |
| Health-care utilization : total number of admission in the Intensive care Unit up to one year after the first hospital admission | Society-specific endpoint | 12 months after first hospital admission |
| Health-care utilization : total number of days in the hospital up to one year after the first hospital admission | Society-specific endpoint | 12 months after first hospital admission |
| Health-care utilization : total number of dialysis sessions up to one year after the first hospital admission | Society-specific endpoint | 12 months after the fisrt hospital admission |
| Health-care utilization : total number of surgical procedures up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admission |
| Health-care utilization : total number of radiotherapeutic sessions up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admission |
| Health-care utilization : total number of radiologic investigations up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admissions |
| Health-care utilization : total number of blood analyses up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admission |
| Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission | Society-specific endpoint | 12 months after the first hospital admission |
| 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. |
| 6226917 | Background | 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. |
| 28882192 | Background | 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. |
| 35107822 | Background | 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. |
| Background | US Department of Health and Human Services. Hospital compare quality of care. 2011. www.hospitalcompare.hhs.gov |
| 11491192 | Background | 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. |
| 39230678 | Background | 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. |
| 36943825 | Background | Benoit DD, Vanheule S, Manesse F, Anseel F, De Soete G, Goethals K, Lievrouw A, Vansteelandt S, De Haan E, Piers R; CODE study group. Coaching doctors to improve ethical decision-making in adult hospitalised patients potentially receiving excessive treatment: Study protocol for a stepped wedge cluster randomised controlled trial. PLoS One. 2023 Mar 21;18(3):e0281447. doi: 10.1371/journal.pone.0281447. eCollection 2023. |
| 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. |
| 26784775 | Background | Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603. |
| 24240830 | Background | Kompanje EJ, Piers RD, Benoit DD. Causes and consequences of disproportionate care in intensive care medicine. Curr Opin Crit Care. 2013 Dec;19(6):630-5. doi: 10.1097/MCC.0000000000000026. |
| 20934213 | Background | Curtis JR, Vincent JL. Ethics and end-of-life care for adults in the intensive care unit. Lancet. 2010 Oct 16;376(9749):1347-53. doi: 10.1016/S0140-6736(10)60143-2. Epub 2010 Oct 11. |
| Apr 3, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003142 | Communication |
| D003643 | Death |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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