Advance Care Planning With Older Patients Who Have End-stage Kidney Disease: Feasibility of a Deferred Entry Randomised Controlled Trial Incorporating a Mixed Methods Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Kidney Disease Quality
研究概览
简要总结
This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.
详细描述
Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.
Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.
However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.
To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attending the renal units taking part in the study
- •Receiving renal replacement therapy
- •Capacity to understand, retain, and weigh the necessary information and communicate their decisions
- •Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.
排除标准
- •Expected to die in the next three months
结局指标
主要结局
Kidney Disease Quality
时间窗: 12 weeks post intervention
Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined.
次要结局
- Depression(12 weeks post intervention)
- Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences(12 weeks post intervention)
- The Degree to Which the Patient Felt That They Had Shared in Decision-making.(12 weeks post intervention)
研究者
Peter O'Halloran
Dr
Queen's University, Belfast