Advanced Directives in Palliative Care: Physician's Role on Caregiver's Empowerment as Patient's Surrogates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Agreement between patients´ and caregivers´ answers in the Advance Directives´ document
研究概览
简要总结
A prospective, single-blinded, controlled, and randomized trial to find if physician's use of the Portuguese Advance Directives, in palliative care, as a communication tool between patients and caregivers, improves the agreement and reliability between patients and their health surrogates, in their decisions about end-of-life care.
详细描述
This trial was a prospective, single-blinded, controlled, and randomized study analyzing if Advance Directives' discussion between patients and caregivers, promoted by a palliative care physician, improves concordance between them, concerning to patients' last wishes, therefore improving surrogates' accuracy when caregivers decide and act on behalf of the patients. This trial was conducted in a central hospital of Portugal's north inland, serving an estimated population of 465.000 habitants. Patients referenced to all three units of the palliative care service from September 2018 to September 2019, and caregivers, were sequentially approached and recruited on the first consult.
All participants gave written consent to enroll in the trial. This study occurred in two phases, within a 1-month interval. At baseline (phase 1) participants separately fulfilled the Advance Directives' document considering patients' preferences for end-of-life care. Caregivers also fulfill a similar document with their own end-of-life preferences.
Dyads were then randomly assigned to two different groups - The Advance Directives and the Control groups.
Simple individual randomization was previously informatically achieved and the randomization sequence was disclosed by a sealed envelope only after trial enrollment of the dyad, to ensure proper investigator concealment. Both patients and caregivers were blinded to the assigned group until the end of the trial. In both groups (Advance Directives and Control), dyads were engaged in a conference meeting, in the same room, with the same average duration, with the same investigator.
In the Advance Directives group, the palliative care physician promoted an open discussion between patients and caregivers, about patients' answers to the Advance Directives document. In the Control group, the palliative care physician underwent a conference with both patients and caregivers to evaluate patients' clinical symptoms.
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 (Participant)
盲法说明
All participants were blinded to the allocated intervention, from the beginning to the end of the trial. Investigator only had access to the allocation group after participants enrollment on the trial, sociodemographic data collected, and phase 1 Advance Directives fulfilled.
Preliminary data analysis was made without knowledge of the participants' allocated group
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
- •Adult patients with 18 years or more
- •Patients referenced to the palliative care service with a chronic, progressive, and incurable disease
- •Patients with the ability to comprehend, write and speak the Portuguese language
- •Patients with an absence of major cognitive disorders (Portuguese validated Mini-Mental State Test score superior to 22, 25, or 27, according to patients' scholarly)
- •Patients that accepted to participate in the trial
- •Patients who were capable of nominate a caregiver as their surrogate in decision making
- •Adult caregivers with 18 years or more
- •Caregivers who were nominated by patients as their surrogate decision-maker
- •Caregivers with the ability to comprehend, write and speak the Portuguese language
- •Caregivers that accepted to participate in the trial
排除标准
- •Patients or caregivers that refused to participate
- •Patients with cognitive impairment
- •Patients with incapacity to dialogue
- •Patients who were too sick to cooperate
- •Patients without a caregiver
结局指标
主要结局
Agreement between patients´ and caregivers´ answers in the Advance Directives´ document
时间窗: 1 month
Agreement between patients and their caregivers was accessed with the Overall Proportion of Agreement (Overall PA) and Proportion of Specific Agreement (Yes PA and No PA), for the 12 questions of the Portuguese Advance Directives, on the Advance Directives and Control group
Reliability of the results of agreement between patients´ and caregivers' answers in the Advance Directives´ document
时间窗: 1 month
Reliability was accessed with Cohen's kappa (k). (Cohen, 1960). We assumed Landis and Koch's (1977) interpretation of κ value. According to these authors, a κ value of 0.20 represents slight reliability, a value between 0.21 and 0.40 fair reliability, a value between 0.41 and 0.60 moderate reliability, a value between 0.61 and 0.80 substantial reliability, and a value of 0.81-1.00 indicates almost perfect reliability
次要结局
- Agreement between caregivers' answers as patients' surrogates and caregivers' answers about their own end-of-life preferences(1 month)
研究者
Catarina Sampaio Martins
Principal Investigator
Universidade do Porto