An interventional study of Usual Care Group and CODE II intervention in Decision Making ,Shared, Leadership and End of Life Communication, sponsored by University Hospital, Ghent. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Supportive care
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.
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719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 360 is above the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Other: Usual Care Group
Behavioral: CODE II intervention
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.
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.
Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay
Patient-specific endpoint
Time frame: 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
Time frame: at the start and the end of the 14 month study period
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.
Time frame: 3 weeks after the patient's hospital discharge
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: at the end of the 14 month study period
Incidence of death up to one year after first hospital admission
Patient-specific endpoint
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At the end of the 14 month study period
Percentage of clinicians with intention of leaving their job
Clinician-specific endpoint
Time frame: At the start and end of the 14 month study period
Percentage of clinicians with sick leave
Team-specific endpoint
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after the first hospital admission
Health-care utilization : total hospital cost by the hospital billing record up to one year after the first hospital admission
Society-level endpoint
Time frame: 12 months after first hospital admission
Health-care utilization : total number of emergency department visits up to one year after the first hospital admission
Society-specific endpoint
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after the first hospital admission
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Start is estimated for Apr 2026; primary completion for Jun 2027, 14 months later.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 14 months is below that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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