Effects of a Decision Support Intervention on End-of-life Care Planning in Patients With Advanced Chronic Obstructive Pulmonary Disease and Their Family Members: A Mixed Method Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Decisional conflict at T0
研究概览
简要总结
This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition. However, patients with advanced COPD and their family members generally are unprepared for end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to address the patients' decisional needs for the difficult decisions in EOL care. The participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •of patients:
- •are aged 50 years or over
- •have been diagnosed with COPD
- •are cognitively sound (scored > 5 on the validated Abbreviated Mental Test (Hong Kong version) [AMT-HK])
- •meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition
- •can nominate a family member who would take part in their healthcare decision- making.
- •Inclusion Criteria of patients' family members:
- •are aged 18 years or over,
- •can communicate in Cantonese,
- •have at least one personal contact per week with the patient in the past 6 months and
- •are willing to join the study. Family members will be excluded if they score < 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months.
排除标准
- •non-communicable due to a severe hearing impairment, dysphasia or a language barrier;
- •are receiving palliative care services or
- •have already completed ACP or an advance directive.
研究组 & 干预措施
Intervention Group
Decision Support Intervention
干预措施: Decision Support Intervention (Behavioral)
Control Group
Health coaching
干预措施: Health Coaching (Behavioral)
结局指标
主要结局
Decisional conflict at T0
时间窗: Baseline
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Decisional conflict at T1
时间窗: 1-month post allocation
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Decisional conflict at T2
时间窗: 6-month post allocation
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
次要结局
- Self-efficacy for ACP at T1(1-month post allocation)
- Readiness for ACP at T1(1-month post allocation)
- Readiness for ACP at T2(6-month post allocation)
- Advance directives at T2(6-month post allocation)
- Self-efficacy for ACP at T0(Baseline)
- Family members' engagement in ACP at T0(Baseline)
- End-of-life care preferences at T1(1-month post allocation)
- Readiness for ACP at T0(Baseline)
- Self-efficacy for ACP at T2(6-month post allocation)
- Family members' engagement in ACP at T1(1-month post allocation)
- End-of-life care preferences at T2(6-month post allocation)
- Family members' engagement in ACP at T2(6-month post allocation)
研究者
Helen YL Chan
Professor
Chinese University of Hong Kong