Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.
Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)
Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.
Participants will:
- Symptom management.
- Respect for the autonomy of the patient and his/her family environment.
- Respectful management of clinical information.
- Provision of holistic care and support.
详细描述
We designed a stepped wedge cluster randomized trial The study is implementation in 5 Chilean hospitals, admitting 248 patients.
Pre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.
Post-intervention: Palliative care protocol to improve the quality of care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years old and older
- •Hospitalization in critical care unit for more than 48 hrs.
- •Medical indication of therapeutic effort limitation, defined as: a) Non-initiation or withdrawal of life support therapies: invasive mechanical ventilation, vasoactive drugs, cardiopulmonary resuscitation, renal replacement therapy.
排除标准
- •Severe communication disorder and cultural language limitation (language other than Spanish).
- •Absence of legal representative and/or caregiver.
- •Brain dead patient.
结局指标
主要结局
Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).
时间窗: From recruitment until death or day 5 of follow up
The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety
次要结局
- Family satisfaction(Up to 4 week after death or hospital discharge)