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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay
研究概览
简要总结
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.
详细描述
See protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Usual care
干预措施: Usual Care Group (Other)
CODE II intervention
干预措施: CODE II intervention (Behavioral)
结局指标
主要结局
Incidence of written DNI-DNACPR order between hospital admission and the end of the first hospital stay
时间窗: At the end of the 14 months study period
Patient-specific endpoint
Ethical decision-making climate questionnaire (EDMCQ)
时间窗: 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
次要结局
- Hospital Anxiety and Depression Scale (HADS)(3 weeks after the patient's hospital discharge)
- European quality of dying and death family questionnaire (Euro-QODD)(3 weeks after the patient's hospital discharge)
- Incidence of death up to one year after first hospital admission(12 months after first hospital admission)
- 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))(12 months after first hospital admission)
- Health-care utilization : total number of chemotherapeutic treatments up to one year after the first hospital admission(12 months after the first hospital admission)
- Hospital Consumer Assessment of Healthcare Providers and Systems instrument(3 weeks after the patient's hospital discharge)
- Sinclair Compassion Questionnaire-Short Form (SCQ-SF)(3 weeks after the patient's hospital discharge)
- Satisfaction according to the European Family Satisfaction in the ICU (Euro-FS) score(3 weeks after the patient's hospital discharge)
- Hospital Anxiety and Depression Scale (HADS)(3 weeks after hospital discharge)
- Pain according to the Numeral Rating scale (NRS) : sum of the average daily score up to the end of the first hospital stay(at the end of the 14 month study period)
- 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(at the end of the 14 month study period)
- 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(At the end of the 14 months study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving cardio-pulmonary resuscitation up to one year after the first hospitalisation(at the end of the 14 months study period)
- Potentially inappropriate or burdensome treatments : incidence of admission in the intensive care unit up to one year after the first hospitalisation(At the end of the 14 month study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving invasive mechanical ventilation up to one year after the first hospitalisation(At the end of the 14 month study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving dialysis up to one year after the first hospitalisation(At the end of the 14 month study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving a surgical procedure up to one year after the first hospitalisation(At the end of the 14 month study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving chemotherapy up to one year after the first hospitalisation(At the end of the 14 month study period)
- Potentially inappropriate or burdensome treatments : incidence of receiving radiotherapy up to one year after the first hospitalisation(At the end of the 14 months study period)
- Differences in EDMCQ between doctors and nurses(at the start and end of the 14 month study period)
- Percentage of (mild-moderate-severe-extreme) stress related to a perception of excessive treatment(At the end of the 14 month study period)
- Percentage of clinicians with intention of leaving their job(At the start and end of the 14 month study period)
- Percentage of clinicians with sick leave(At the start and end of the 14 month study period)
- Ethical pratice score(At the start and end of the 14 month study period)
- 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(At the end of the 14 months study period)
- Incidence of death up to one year after first hospital admission in the overall patient population admitted in the participating wards(At the end of the 14 month study period)