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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Ethical decision-making climate questionnaire (EDMCQ)
研究概览
简要总结
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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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Patients will be blinded to the 4 months intervention period in junior and senior doctors.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ethical decision-making climate questionnaire (EDMCQ)
时间窗: 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
时间窗: at the end of the 12 months study period
Patient-specific endpoint
次要结局
- Incidence of death one year after first hospital admission(12 months after first hospital admission)
- 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)
- 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)
- 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)
- European quality of dying and death family questionnaire (Euro-QODD family)(3 weeks after the patient's death)
- Impact of events scale-revised (IES-R)(3 weeks after the patient's death)
- Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment(at the end of the 12 month study period)
- Health-care utilization : total number of dialyses(12 months after first hospital discharge)
- Health-care utilization : total number of radiological investigations(12 months after first hospital discharge)
- Health-care utilization : total number of blood analyses(12 months after first hospital discharge)
- Number of days admitted in the hospital up the end of the first hospital stay(at the end of the 12 months study period)
- 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)
- 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)
- 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)
- 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)
- 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)
- Hospital anxiety and depression scale (HADS)(3 weeks after the patient's hospital discharge)
- Health-care utilization : total number of admissions in the intensive care unit(12 months after first hospital discharge)
- Health-care utilization : total number of surgical procedures(12 months after first hospital discharge)
- 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)
- 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)
- Satisfaction according to the European Family Satisfaction in the ICU score (Euro FS)(3 weeks after the patient's hospital discharge)
- Percentage of clinicians with sick leave(at the start and end of the 12 month study period)
- 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)
- Health-care utilization : total number of days in the intensive care unit(12 months after first hospital discharge)
- Health-care utilization : total number of chemotherapeutic treatments(12 months after first hospital discharge)
- 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)
- European quality of dying and death family questionnaire (Euro-QODD nurse)(within 1 week after death)
- Health-care utilization : total number of hospital admissions(12 months after first hospital discharge)
- Health-care utilization : total number of days in the hospital(12 months after first hospital discharge)
- 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)
- Percentage of clinicians with intention of leaving their job(at the start and end of the 12 month study period)
- Ethical pratice score(at the start and end of the 12 month study period)
- Health-care utilization : total number of emergency department visits(12 months after first hospital discharge)
- Health-care utilization : total number of radiotherapeutic treatments(12 months after first hospital discharge)