Preparing Surrogates of Dementia Patients for In-the-moment Decision Making Through a Structured Advance Care Planning Intervention: A Mixed-methods Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making.
The main question it aims to answer is, whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
Participants will be randomized to ACP intervention vs. usual care.
- patients of the Intervention group will be assessed on palliative care needs, and surrogates of the Intervention group will participate in 2-3 nurse-led ACP consultations;
- surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study.
Researchers will compare the intervention group and control group to see any differences in:
- surrogate preparedness for decision-making,
- distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life,
- enrolment in Community Geriatric Assessment Team end-of-life care program,
- advanced care program documentation in medical record,
- patient comfort at end-of-life,
- hospitalizations in the last 6 months of life.
详细描述
In order to test the ACP interventions that aim to engage surrogates' participation in ACP and improve their preparedness for decision-making rather than on documentation of advance care plans alone, the research team has developed a pilot structured, nurse-facilitated post-discharge ACP intervention with the aim to improve surrogates' preparedness for in-the-moment decision-making.
It does so by incorporating best practices for ACP communication, drawing from prior work of the research team and existing literature, combined with a focus on developing surrogates' self-efficacy for decision-making guided by Bandura's Social Cognitive Theory.
This application aims to test the intervention's effects on surrogate outcomes (decision-making self-efficacy and distress), patient outcomes (patient comfort and healthcare utilization), as well as process outcomes (ACP documentation, end-of-life care discussions between family members, and enrolment in end-of-life care programs).
The research hypotheses to be tested are as follows: the investigators will test whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research staff will be blinded to the study arm when collecting data from family surrogates by telephone at follow up time-points. The study biostatistician will also be blinded to the allocation of the study arm.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version
时间窗: Baseline, 2-month, 6-month
This is a modified 17-item version of the FDMSE, a valid and reliable scale that quantifies a family member's confidence (0-100, where 100 = greatest self-efficacy) in end-of-life care decision-making for a loved one.
Family Distress in Advanced Dementia Scale (FDAD) Dementia Preparedness Subscale - Chinese version
时间窗: Baseline, 2-month, 6-month
The FDAD is a validated 21-item scale rated on a 1-5 scale, with higher scores indicating greater family distress. The scale assesses three domains of distress of family members of nursing home residents with dementia: Emotional Distress, Dementia Preparedness, and Clinician Relations. The Chinese version of the FDAD has high content validity (CVI = 0.95). It has good internal consistency (Cronbach's alpha 0.83) and moderate test-retest reliability (ICC = 0.64). We will use the 5-item Dementia Preparedness subscale to evaluate family distress associated with lack of knowledge of the course of dementia and surrogate medical decision making.
次要结局
- End-of-life care discussions with other family members(Baseline, 2-month, 6-month)
- Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program(2-month, 6-month)
- Comfort Assessment in Dying with Dementia (CAD-EOLD)(2-month, 6-month)
- Documentation of ACP discussions with medical providers(Baseline, 2-month, 6-month)
- Unplanned hospital admissions and hospitalization days(2-month, 6-month)
研究者
YUEN Jacqueline Kwan Yuk
Clinical Assistant Professor
The University of Hong Kong