Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Rate of PTSD
研究概览
简要总结
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.
There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes.
Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.
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
- Single (Outcomes Assessor)
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
- •The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).
- •Inclusion Criteria:
- •Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
- •verbal consent to participate
- •Able to communicate in French
排除标准
- •representant of a patient < 18 years old
- •representant of a patient whose stay in ICU lasted less than 48 hours
- •representant of a patient without social security
研究组 & 干预措施
Written document
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.
干预措施: Explaining withholding and withdrawing life-sustaining therapies along with a written document (Other)
Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
干预措施: Explaining withholding and withdrawing life-sustaining therapies following standard procedure (Other)
结局指标
主要结局
Rate of PTSD
时间窗: 3 months
PTSD is assessed with Impact Event Scale (IES) on the family representative
次要结局
- Mean level of HADS (anxiety and depression subscales)(3 months)
- Medical Doctor satisfaction with the processus(ICU discharge (an average of 3 weeks))
- Rate of depression(3 months)
- Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge(An average of 6 days)
- Description of the processus(ICU discharge (an average of 3 weeks))
- Rate of anxiety(3 months)
- Mean level of IES(3 months)
- Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies(An average of 6 days)
- Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital(ICU discharge (an average of 3 weeks))