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
- •Dyads of patients with dementia admitted for an unplanned hospital admission and their family surrogate will be eligible for the study.
- •Inclusion Criteria of patients:
- •Patient (a) at or above the age of 60 years old, (b) with diagnosis of dementia based on DSM-5 Criteria for Major Neurocognitive Disorder and Stage 6d or above on the Functional Assessment Staging Tool (FAST), (c) residing in a residential care home that is participating in Hospital Authority Enhanced Community Geriatric Assessment Team End-of-Life (CGAT EOL) Care program and (d) has an eligible family decision-maker.
排除标准
- •of patients:
- •Patient with (i) prior completed advance directive, (ii) On tube feeding at the time of index admission, (iii) currently enrolled in an end-of-life care program or palliative care service, or (iv) with family members who lack consensus on the primary family surrogate decision-maker.
- •Inclusion Criteria of surrogates:
- •Surrogate (a) at or above the age of 18 years old, (b) identified as the patient's next of kin or legal guardian who is the 'key decision maker' in hospital records, and (c) able to provide informed consent for him/herself and the patient.
研究组 & 干预措施
ACP Intervention arm
The intervention consists of two components:
- Palliative care needs assessment During the patient's hospitalization, the ACP nurse facilitator will conduct a palliative care needs assessment including assessment of patient's dementia severity (using the FAST scale), symptoms, clinical condition, nutritional and functional status, as well as psychosocial information.
- Structured nurse-facilitated post-discharge ACP consultations with use of video decisions aids
- ACP consultation 1 (1-2 weeks post discharge)
- Video decision aids (Between consultations 1 and 2)
- ACP consultation 2 (2-3 weeks post discharge)
- ACP consultation 3 (3-4 weeks post discharge), if needed
At the completion of the ACP intervention, the ACP nurse facilitator may refer patients to the CGAT EOL program via the link nurse if fulfill the program criteria and agreed by the family surrogate(s).
干预措施: Nurse-facilitated advance care planning intervention (Other)
Usual care arm
Patient and family surrogate dyads will receive usual hospital and post-discharge care. A publicly available information leaflet on advance care planning from the Hospital Authority's website will be given to control family surrogates after randomization. If a surrogate seeks assistance in discussing advance care planning, the research staff will advise the surrogate to speak with the patient's medical providers.
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