Coaching Doctors in Ethical Decision-making (CODE)
- Conditions
- LeadershipEnd of LifeInterdisciplinary Communication
- Interventions
- Behavioral: CODE interventionOther: Usual care
- Registration Number
- NCT05167019
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description The CODE intervention CODE intervention 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. Usual care Usual care Usual care
- Primary Outcome Measures
Name Time Method Ethical decision-making climate questionnaire (EDMCQ) 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
Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
- Secondary Outcome Measures
Name Time Method Incidence of death one year after first hospital admission 12 months after first hospital admission Patient-specific endpoint
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). 12 months after first hospital admission Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay 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).
European quality of dying and death family questionnaire (Euro-QODD family) 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
Impact of events scale-revised (IES-R) 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.
Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment at the end of the 12 month study period Clinician-specific endpoint
Health-care utilization : total number of dialyses 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of radiological investigations 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of blood analyses 12 months after first hospital discharge Society-specific endpoint
Number of days admitted in the hospital up the end of the first hospital stay at the end of the 12 months study period Patient-specific endpoint
Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of first hospital stay 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).
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 at the end of the 12 months study period Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Hospital anxiety and depression scale (HADS) 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)
Health-care utilization : total number of admissions in the intensive care unit 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of surgical procedures 12 months after first hospital discharge Society-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS) 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
Percentage of clinicians with sick leave at the start and end of the 12 month study period Team-specific endpoint
Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay at the end of the 12 months study period Society-specific endpoint
Health-care utilization : total number of days in the intensive care unit 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of chemotherapeutic treatments 12 months after first hospital discharge Society-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
European quality of dying and death family questionnaire (Euro-QODD nurse) 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
Health-care utilization : total number of hospital admissions 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of days in the hospital 12 months after first hospital discharge Society-specific endpoint
Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay at the end of the 12 months study period Patient-specific endpoint
Percentage of clinicians with intention of leaving their job at the start and end of the 12 month study period Clinician-specific endpoint
Ethical pratice score 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
Health-care utilization : total number of emergency department visits 12 months after first hospital discharge Society-specific endpoint
Health-care utilization : total number of radiotherapeutic treatments 12 months after first hospital discharge Society-specific endpoint
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, Belgium