Clinical trial NCT05167019: Coaching Doctors in Ethical Decision-making (CODE)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Interdisciplinary Communication
Leadership
Keywords: Treatment limitation decisions
Interdisciplinary collaboration
Coaching
Self-reflective and empowering leadership
Ethical climate
Prognostic uncertainty
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sample size for this stepped wedge randomised controlled trial is listed for patients potentially receiving excessive treatment (n=1700) together with one of their relatives who will be identified by junior doctors (n=75) , senior doctors (n=75) and nurses (n= 600) working in 10 departments of the Ghent university hospital during a 12 months period. Junior and senior doctors working in each department will be coached in self-reflective and empowering leadership, and in managing group dynamics with regard to patients potentially receiving excessive treatment for whom they are in charge of during a 4 month period. The impact of the intervention on the quality of ethical decision-making will be assessed at the patient (n=1700), relatives (n=1700) and team level (n=750).
Primary purpose: SUPPORTIVE_CARE

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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Eligibility criteria: Inclusion criteria

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

Exclusion criteria :

1. Clinicians'level : no exclusion criteria
2. Patients' level : patients who cannot understand Dutch questionnaires
3. Family : persons who cannot understand Dutch questionnaires

Primary outcomes:
measure: Incidence of written do-not-intubate and -resuscitate (DNIR) order between hospital admission and the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Ethical decision-making climate questionnaire (EDMCQ)
timeFrame: at the start and end of the 12 month study period
Secondary outcomes:
measure: Incidence of death one year after first hospital admission
timeFrame: 12 months after first hospital admission
measure: 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).
timeFrame: 12 months after first hospital admission
measure: Number of days admitted in the hospital up the end of the first hospital stay
timeFrame: at the end of the 12 months study period
measure: Pain according to the Numeral rating scale (NRS) : sum of the average daily score up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Pain according to the Numeral rating scale (NRS) : number of days with an average score > 3 up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: 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
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of receiving cardio-pulmonary resuscitation up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of admission in the intensive care unit up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of non-invasive mechanical ventilation in the intensive care unit up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of receiving dialysis up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of receiving a surgical procedure up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of receiving a chemotherapeutic treatment up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Potentially inappropriate or burdersome treatments : incidence of receiving a radiotherapeutic treatment up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
timeFrame: 3 weeks after hospital discharge
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 3 weeks after hospital discharge
measure: European quality of dying and death family questionnaire (Euro-QODD nurse)
timeFrame: within 1 week after death
measure: European quality of dying and death family questionnaire (Euro-QODD family)
timeFrame: 3 weeks after the patient's death
measure: Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)
timeFrame: 3 weeks after the patient's hospital discharge
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 3 weeks after the patient's hospital discharge
measure: Impact of events scale-revised (IES-R)
timeFrame: 3 weeks after the patient's death
measure: Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment
timeFrame: at the end of the 12 month study period
measure: Percentage of clinicians with intention of leaving their job
timeFrame: at the start and end of the 12 month study period
measure: Percentage of clinicians with sick leave
timeFrame: at the start and end of the 12 month study period
measure: Ethical pratice score
timeFrame: at the start and end of the 12 month study period
measure: Health-care utilization : total hospital cost by the hospital billing record up to the end of first hospital stay
timeFrame: at the end of the 12 months study period
measure: Health-care utilization : total number of emergency department visits
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of hospital admissions
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of admissions in the intensive care unit
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of days in the hospital
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of days in the intensive care unit
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of dialyses
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of surgical procedures
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of chemotherapeutic treatments
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of radiotherapeutic treatments
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of blood analyses
timeFrame: 12 months after first hospital discharge
measure: Health-care utilization : total number of radiological investigations
timeFrame: 12 months after first hospital discharge
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Dominique Benoit, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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