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NCT Number: NCT07327450

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

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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Key information

Conditions

Decision Making ,Shared Behavior Coaching Communication Death End of Life Communication End of Life Decision Making End of Life Patients Ethical Sensitivities Leadership Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

See protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

CODE II intervention

Behavioral
  • 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.

Primary outcomes

  1. Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay

    Time frame: At the end of the 14 months study period

    Patient-specific endpoint

  2. Ethical decision-making climate questionnaire (EDMCQ)

    Time frame: at the start and the end of the 14 month study period

    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

Secondary outcomes

  1. Hospital Consumer Assessment of Healthcare Providers and Systems instrument

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  2. Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

    Time frame: 3 weeks after the patient's hospital discharge

    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. Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 weeks after hospital discharge

    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

  5. European quality of dying and death family questionnaire (Euro-QODD)

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  6. Pain according to the Numeral Rating scale (NRS) : sum of the average daily score up to the end of the first hospital stay

    Time frame: at the end of the 14 month study period

    Patient-specific endpoint; Single-item assessment of pain ranging from 0 (no pain) to 10 (worst possible pain)

  7. 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

    Time frame: at the end of the 14 month study period

    Patient-specific endpoint. Single-item assessment of pain raging from 0 (no pain) to 10 (worst possible pain).

  8. Incidence of death up to one year after first hospital admission

    Time frame: 12 months after first hospital admission

    Patient-specific endpoint

  9. 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))

    Time frame: 12 months after first hospital admission

    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

  10. 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

    Time frame: At the end of the 14 months study period

    Patient-specific endpoint

  11. Potentially inappropriate or burdensome treatments : incidence of receiving cardio-pulmonary resuscitation up to one year after the first hospitalisation

    Time frame: at the end of the 14 months study period

    Patient-specific endpoint

  12. Potentially inappropriate or burdensome treatments : incidence of admission in the intensive care unit up to one year after the first hospitalisation

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  13. Potentially inappropriate or burdensome treatments : incidence of receiving invasive mechanical ventilation up to one year after the first hospitalisation

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  14. Potentially inappropriate or burdensome treatments : incidence of receiving dialysis up to one year after the first hospitalisation

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  15. Potentially inappropriate or burdensome treatments : incidence of receiving a surgical procedure up to one year after the first hospitalisation

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  16. Potentially inappropriate or burdensome treatments : incidence of receiving chemotherapy up to one year after the first hospitalisation

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  17. Potentially inappropriate or burdensome treatments : incidence of receiving radiotherapy up to one year after the first hospitalisation

    Time frame: At the end of the 14 months study period

    Patient-specific endpoint

  18. Hospital Consumer Assessment of Healthcare Providers and Systems instrument

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  19. Sinclair Compassion Questionnaire-Short Form (SCQ-SF)

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  20. Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score

    Time frame: 3 weeks after the patient's hospital discharge

    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.

  21. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 weeks after the patient's hospital discharge

    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

  22. Differences in EDMCQ between doctors and nurses

    Time frame: at the start and end of the 14 month study period

    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.

  23. Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment

    Time frame: At the end of the 14 month study period

    Clinician-specific endpoint

  24. Percentage of clinicians with intention of leaving their job

    Time frame: At the start and end of the 14 month study period

    Clinician-specific endpoint

  25. Percentage of clinicians with sick leave

    Time frame: At the start and end of the 14 month study period

    Team-specific endpoint

  26. Ethical pratice score

    Time frame: At the start and end of the 14 month study period

    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

  27. 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

    Time frame: At the end of the 14 months study period

    Patient-specific endpoint

  28. Incidence of death up to one year after first hospital admission in the overall patient population admitted in the participating wards

    Time frame: At the end of the 14 month study period

    Patient-specific endpoint

  29. Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admission

    Society-specific endpoint

Other outcomes

  1. Health-care utilization : total hospital cost by the hospital billing record up to one year after the first hospital admission

    Time frame: 12 months after first hospital admission

    Society-level endpoint

  2. Health-care utilization : total number of emergency department visits up to one year after the first hospital admission

    Time frame: 12 months after first hospital admission

    Society-specific endpoint

  3. Health-care utilization : total number of hospitalizations up to one year after the first hospital admission

    Time frame: 12 months after first hospital admission

    Society-specific endpoint

  4. Health-care utilization : total number of admission in the Intensive care Unit up to one year after the first hospital admission

    Time frame: 12 months after first hospital admission

    Society-specific endpoint

  5. Health-care utilization : total number of days in the hospital up to one year after the first hospital admission

    Time frame: 12 months after first hospital admission

    Society-specific endpoint

  6. Health-care utilization : total number of dialysis sessions up to one year after the first hospital admission

    Time frame: 12 months after the fisrt hospital admission

    Society-specific endpoint

  7. Health-care utilization : total number of surgical procedures up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admission

    Society-specific endpoint

  8. Health-care utilization : total number of radiotherapeutic sessions up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admission

    Society-specific endpoint

  9. Health-care utilization : total number of radiologic investigations up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admissions

    Society-specific endpoint

  10. Health-care utilization : total number of blood analyses up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admission

    Society-specific endpoint

  11. Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission

    Time frame: 12 months after the first hospital admission

    Society-specific endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Benoit, MD, PhD

CONTACT

[email protected]

+32 (9) 332 27 75

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: CODE II

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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