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Completed

NCT Number: NCT05167019

Coaching Doctors in Ethical Decision-making (CODE)

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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Key information

Conditions

End of Life Death Interdisciplinary Communication Leadership Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinicians' level : doctors (including department head) and nurses (including head nurses) taking care of adult hospitalized patients in the 10 participating departments
  • Patients' level : first hospitalization of adult patients who are potentially receiving excessive treatment.
  • Family level : family of adult patients who are potentially receiving excessive treatment

Exclusion criteria

  • Clinicians'level : no exclusion criteria
  • Patients' level : patients who cannot understand Dutch questionnaires
  • Family : persons who cannot understand Dutch questionnaires

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  2. Ethical decision-making climate questionnaire (EDMCQ)

    Time frame: at the start and end of the 12 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 iindicate higher quality of ethical decision-making

Secondary outcomes

  1. Incidence of death one year after first hospital admission

    Time frame: 12 months after first hospital admission

    Patient-specific endpoint

  2. 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).

    Time frame: 12 months after first hospital admission

    Patient-specific endpoint

  3. Number of days admitted in the hospital up the end of the first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

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

    Time frame: at the end of the 12 months study period

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

  5. Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

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

  6. 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

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  7. Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  8. Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  9. Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  10. Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  11. Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  12. Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  13. Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

  14. Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Patient-specific endpoint

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

    Time frame: 3 weeks after hospital discharge

    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

  16. Hospital anxiety and depression scale (HADS)

    Time frame: 3 weeks after hospital discharge

    Patient-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)

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

    Time frame: within 1 week after death

    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

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

    Time frame: 3 weeks after the patient's death

    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

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

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

    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

  20. Hospital anxiety and depression scale (HADS)

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

    Family-specific endpoint. This score is interpreted as follows : 0-7 (normal), 8-10 (mild), 11-21 (moderate to severe)

  21. Impact of events scale-revised (IES-R)

    Time frame: 3 weeks after the patient's death

    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.

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

    Time frame: at the end of the 12 month study period

    Clinician-specific endpoint

  23. Percentage of clinicians with intention of leaving their job

    Time frame: at the start and end of the 12 month study period

    Clinician-specific endpoint

  24. Percentage of clinicians with sick leave

    Time frame: at the start and end of the 12 month study period

    Team-specific endpoint

  25. Ethical pratice score

    Time frame: at the start and end of the 12 month study period

    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

  26. Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay

    Time frame: at the end of the 12 months study period

    Society-specific endpoint

  27. Health-care utilization : total number of emergency department visits

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  28. Health-care utilization : total number of hospital admissions

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  29. Health-care utilization : total number of admissions in the intensive care unit

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  30. Health-care utilization : total number of days in the hospital

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  31. Health-care utilization : total number of days in the intensive care unit

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  32. Health-care utilization : total number of dialyses

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  33. Health-care utilization : total number of surgical procedures

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  34. Health-care utilization : total number of chemotherapeutic treatments

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  35. Health-care utilization : total number of radiotherapeutic treatments

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  36. Health-care utilization : total number of blood analyses

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

  37. Health-care utilization : total number of radiological investigations

    Time frame: 12 months after first hospital discharge

    Society-specific endpoint

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Coaching Doctors to Improve Ethical Decision-making in Adult Hospitalized Patients Potentially Receiving Excessive Treatment: a Step Wedge Cluster Randomized Trial in 10 Departments of the Ghent University Hospital (CODE)

Acronym: CODE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 22, 2021
Registry last updated
May 9, 2024

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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