End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Training to Palliative Care in the Intensive Care Setting. A Multicenter Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- To assess whether, compared with usual care, the implementation of a palliative care protocol for mechanically ventilated patients-combined with dedicated staff training-improves adherence to guidelines.
研究概览
简要总结
The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals
详细描述
Among ICU patients who die after a decision to withdraw life-sustaining therapies, most are receiving mechanical ventilation (MV). Withdrawal of MV may cause discomfort, and end-of-life practices can have a lasting impact on both families and healthcare professionals. Despite international guidelines and recent legislative changes in France, end-of-life practices in the ICU remain highly variable, indicating substantial opportunities for improvement in patient comfort-focused management.
The ARREVE-3 trial aimes to determine whether a structured palliative care protocol for mechanically ventilated patients undergoing withdrawal of life-sustaining therapies improves the quality of the dying process. Developed in collaboration with palliative care specialists, a psychologist, and a sociologist, the protocol provides standardized guidance on pharmacological and non-pharmacological interventions, including symptom assessment tools, sedation strategies, nursing care, and procedures for withdrawal of life-sustaining treatment. Structured recommendations for support of relatives are also included.
ARREVE-3 is a pragmatic, interventional, cluster-randomized controlled trial, with participating ICUs being unit of randomization to minimize contamination between study arms. ICUs randomized to the intervention arm will apply the palliative care protocol, whereas control ICUs will continue to follow usual care. Physicians and nurses in intervention ICUs will receive standardized training from the coordinating team, complemented by a video-based educational module. Designated local champions within each ICU will support implementation and adherence.to the protocol.
The primary endpoint is adherence to the protocol for end-of-life care. Secondary outcomes include patient comfort, quality of communication with relatives, and the impact of the end-of-life process on relatives and healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years
- •ICU admission for more than 48 hours
- •Receiving invasive mechanical ventilation
- •A documented decision to withdraw life-sustaining therapies, made through a multidisciplinary collegial process and communicated to the designated surrogate decision-maker, family, or relatives
- •At least one visit from a relative prior to the decision to withdraw life-sustaining therapies
- •Provision of informed consent for study participation, or, if the patient lacks decision-making capacity, consent obtained from a relative or legally authorized representative
- •Relative:
- •Age ≥ 18 years
- •Has received at least one medical update regarding the patient's clinical status from an ICU physician prior to the decision to withdraw life-sustaining therapies
- •Has provided informed consent for study participation
排除标准
- •Presence of a tracheostomy
- •Brain death or involvement in an organ donation procedure
- •Absence of any visit from a relative
- •Subject to legal guardianship or other legal protection measures
- •Incarcerated patient
- •Participation in another interventional research study focused on end-of-life care
- •Pregnant or breastfeeding woman
- •Relative:
- •Inability to understand or speak French
- •Subject to legal guardianship or other legal protection measures
研究组 & 干预措施
Palliative care protocol
Protocol for life-support withdrawal and palliative care during the withdrawal process
干预措施: Protocol for palliative care and life-support withdrawal (Other)
Usual Care
Withdrawal of life support at the end of life will be performed according to the usual practices of the participating ICUs
结局指标
主要结局
To assess whether, compared with usual care, the implementation of a palliative care protocol for mechanically ventilated patients-combined with dedicated staff training-improves adherence to guidelines.
时间窗: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days
Proportion of patients receiving adequate sedation (RASS-5 within one hour before withdrawal of life-sustaining therapies) and withdrawal of mechanical ventilation
次要结局
- Evaluation of Sedation(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Administration of neuromuscular blocking agents(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Proportion of Patients Receiving Medications Other Than Sedatives(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Administration of scopolamine(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Administration of paracetamol (acetaminophen)(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Administration of Receiving antiemetic agents(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- The Semi-Lateral (¾ Lateral) Position(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Life-Sustaining Organ Support Management(From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Life-Sustaining Organ Support Management(From inclusion to death, assessed up to 28 days)
- Time from Inclusion to Extubation(From inclusion to date of extubation, assessed up to 28 days)
- Assessment of Sedation(From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Assessment of Pain Management(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Assessment of Comfort Management(From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days)
- Assessment of Communication with Relatives(From inclusion to date of ICU discharge, assessed up to 28 days)
- Assessment of Conflicts(From inclusion to date of ICU discharge, assessed up to 28 days)
- Assessment of Quality of Dying by Relatives(From inclusion to 1 month after death of the patient)
- Anxiety and Depression in Relatives(From inclusion to 1, 3, 6, and 12 months after the death of the patient)
- Post-Traumatic Stress Disorders in Relatives(From inclusion to 1, 3, 6, and 12 months after the death of the patient)
- Prolonged Grief in Relatives(From inclusion to 12 months after the death of the patient)
- Assessment of Quality of Dying by Healthcare Professionals(After the death of the patient, assessed up to 28 days)
- Psychological Impact on Healthcare Professionals(After the death of the patient, assessed up to 28 days)
- Impact on ICU Organization and Staff(Up to 2 years)