The impact of the mySupport advance care planning intervention on family caregivers’ perceptions of decision-making and care for nursing home residents with dementia: pretest–posttest study in six countries
mySupport 预先护理规划干预对照护家庭成员对痴呆症护理院居民决策和护理的影响：六个国家的前后测试研究

Abstract 摘要

Background 背景

the mySupport advance care planning intervention was originally developed and evaluated in Northern Ireland (UK). Family caregivers of nursing home residents with dementia received an educational booklet and a family care conference with a trained facilitator to discuss their relative’s future care.
mySupport 预先护理规划干预最初是在北爱尔兰（英国）开发和评估的。患有痴呆症的养老院居民的家庭照护者收到了一本教育手册，并与经过培训的促进者举行了家庭照护会议，讨论他们亲属的未来护理。

Objectives 目标

to investigate whether upscaling the intervention adapted to local context and complemented by a question prompt list impacts family caregivers’ uncertainty in decision-making and their satisfaction with care across six countries. Second, to investigate whether mySupport affects residents’ hospitalisations and documented advance decisions.
调查是否将适应当地环境的干预措施进行放大，并辅以问题提示清单，对六个国家的家庭照护者在决策过程中的不确定性和对护理满意度的影响。其次，调查 mySupport 是否影响居民的住院情况和已记录的预先决策。

Design 设计

a pretest–posttest design.
一个前测-后测设计。

Setting 设置

in Canada, the Czech Republic, Ireland, Italy, the Netherlands and the UK, two nursing homes participated.
在加拿大、捷克共和国、爱尔兰、意大利、荷兰和英国，有两家养老院参与了。

Participants 参与者

in total, 88 family caregivers completed baseline, intervention and follow-up assessments.
总共有 88 名家庭照顾者完成了基线、干预和随访评估。

Methods 方法

family caregivers’ scores on the Decisional Conflict Scale and Family Perceptions of Care Scale before and after the intervention were compared with linear mixed models. The number of documented advance decisions and residents’ hospitalisations was obtained via chart review or reported by nursing home staff and compared between baseline and follow-up with McNemar tests.
家庭照顾者在干预前后的决策冲突量表和家庭护理感知量表得分，通过线性混合模型进行比较。通过图表审查或由养老院工作人员报告，获取记录的预先决策数量和居民的住院情况，并使用麦克马测试在基线和随访之间进行比较。

Results 结果

family caregivers reported less decision-making uncertainty (−9.6, 95% confidence interval: −13.3, −6.0, P < 0.001) and more positive perceptions of care (+11.4, 95% confidence interval: 7.8, 15.0; P < 0.001) after the intervention. The number of advance decisions to refuse treatment was significantly higher after the intervention (21 vs 16); the number of other advance decisions or hospitalisations was unchanged.
家庭照顾者在干预后报告决策不确定性减少（-9.6，95%置信区间：-13.3，-6.0，P <0.001），对护理的积极感知增加（+11.4，95%置信区间：7.8，15.0；P <0.001）。干预后拒绝治疗的预先决定数量显著增加（21 比 16）；其他预先决定或住院的数量保持不变。

Conclusions 结论

the mySupport intervention may be impactful in countries beyond the original setting.
mySupport 干预可能在原始设置之外的国家产生影响。

Key Points 关键点

• This study implemented an existing intervention adapted to local context in six different countries, providing support for generalisability of the original findings.
  本研究在六个不同国家实施了一个适应当地环境的现有干预措施，为原始研究结果的普适性提供了支持。

• Family caregivers reported less decision-making uncertainty and more positive perceptions of care after receiving the educational intervention.
  家庭照护者在接受教育干预后报告决策不确定性减少，对护理的积极看法增加。

• This study did not find conclusive evidence about the impact of the intervention on the number of hospitalisations or advance decisions of nursing home residents.
  本研究并未找到关于干预措施对住院次数或养老院居民预先决策影响的确凿证据。

• Our findings may encourage nursing home staff to inform family caregivers about dementia and end-of-life care.
  我们的发现可能会鼓励养老院工作人员告知家庭照护者有关痴呆症和临终关怀的信息。

Introduction 介绍

Family caregivers, including relatives, friends or others, often serve as proxy decision makers to achieve person-centred care when a person with dementia is no longer able to contribute to care conversations with care providers [1, 2]. However, they may feel ill prepared for this task and experience decision-making as challenging [3]. This uncertainty can impact family caregivers’ wellbeing [4] and can affect the comfort of persons with advanced dementia [5]. Helping family caregivers reflect on values and preferences of the person with dementia and view dementia as a life limiting condition can be helpful in addressing these issues.
家庭照顾者，包括亲戚、朋友或其他人，通常在患有痴呆症的人无法再参与与护理提供者的护理对话时，充当代理决策者，以实现以人为中心的护理[1, 2]。然而，他们可能感到对这项任务毫无准备，并且认为决策具有挑战性[3]。这种不确定性可能会影响家庭照顾者的幸福感[4]，并可能影响患有晚期痴呆症的人的舒适度[5]。帮助家庭照顾者反思患有痴呆症的人的价值观和偏好，并将痴呆症视为一种限制生命的状况，有助于解决这些问题。

To address family caregivers’ uncertainty in decision-making about care and treatment, the Family Carer Decision Support Intervention was developed and implemented in Northern Ireland (UK) [6]. A randomised controlled trial (RCT) measured the efficacy of the advance care planning intervention across 24 nursing homes. The intervention consisted of an educational booklet for family caregivers and a structured conversation with a trained facilitator. Family caregivers in 12 nursing homes received the intervention and they experienced less decisional conflict and were more satisfied with the nursing home care compared with the family caregivers’ experiences in 12 control homes. However, the impact of the intervention when scaled up outside of the original context may differ. Therefore, six countries collaborated in the mySupport study consortium (https://mysupportstudy.eu/) aimed at adapting the intervention to their local contexts and implement the intervention in their own setting [7]. Two additional general adaptions were made. One, to facilitate upscaling by building internal capacity for family communication, a trained facilitator educated nursing home staff in conducting conversations themselves in their own nursing home (rather than an external facilitator). Two, family caregivers received a list of locally relevant example questions to prompt their engagement during the structured family care meeting, stimulating empowerment and personalised discussions.
为了解决家庭照料者在护理和治疗决策中的不确定性，开发并实施了家庭照料者决策支持干预项目在北爱尔兰（英国）[6]。一项随机对照试验（RCT）测量了 24 家养老院中预先护理规划干预的有效性。该干预包括为家庭照料者提供教育手册和与受过培训的促进者进行结构化对话。12 家养老院的家庭照料者接受了干预，他们在决策冲突方面经历较少，并且对养老院的护理更满意，与 12 家对照养老院中的家庭照料者的经历相比。然而，当干预在原始环境之外扩大规模时，其影响可能会有所不同。因此，六个国家合作参与了 mySupport 研究联盟（https://mysupportstudy.eu/），旨在将干预适应到他们当地的环境，并在自己的设置中实施干预[7]。进行了两项额外的一般性调整。 一、为了便于通过建立家庭沟通的内部能力来促进扩大规模，一位受过培训的促进者教育养老院工作人员自己在他们自己的养老院进行对话（而不是由外部促进者）。二、家庭照护者收到了一个本地相关示例问题清单，以促进他们在结构化家庭照护会议期间的参与，刺激赋权和个性化讨论。

This study aimed to assess the impact of the adapted Family Carer Decision Support intervention on family caregivers’ decision-making uncertainty and their satisfaction with nursing home care for their relative with dementia, across six countries. As a secondary aim, we studied the impact of the intervention on the number of advance decisions and hospitalisations. We thus aimed to determine if the collective results from six countries support the original findings and a successful scale-up beyond the original setting.
本研究旨在评估改编的家庭照顾者决策支持干预对六个国家家庭照顾者在决策不确定性和对其患有痴呆症亲属的养老院护理满意度的影响。作为次要目标，我们研究了干预对预先决策数量和住院次数的影响。因此，我们旨在确定来自六个国家的集体结果是否支持原始发现，并在原始设置之外成功扩大规模。

By studying the impact of an intervention that facilitates conversations about future decision-making in care and awareness of comfort care for people with dementia, this study attends to important nursing home research questions according to international experts [8] and contributes to a currently understudied area [9]. Furthermore, the intervention addresses some fundamental needs of nursing staff in palliative dementia care [10].
通过研究促进与照护中关于未来决策的对话和对患有痴呆症的人的舒适护理意识的干预的影响，本研究关注国际专家提出的重要养老院研究问题[8]，并为目前研究不足的领域做出贡献[9]。此外，该干预还满足了临终期痴呆护理中护理人员的一些基本需求[10]。

Methods 方法

Design and ethical considerations
设计和道德考虑

The mySupport study employs a hybrid effectiveness-implementation design [11] guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) [12]. Since the original RCT indicated the efficacy of the Family Care Decision Support intervention, this design shifts focus to implementation and effectiveness in broader real-world settings [11]. The current study focused on the impact (Effectiveness) of the intervention across countries, after adapting to local context as needed, using a single group, pretest–posttest design. Ethics approval was obtained in each participating country according to local guidelines. Participants provided written informed consent before participation. We used the SQUIRE (2.0) guidelines to structure this report [13] and the TIDieR Checklist to report the intervention [14].
mySupport 研究采用了由 RE-AIM 框架（覆盖范围、有效性、采纳、实施、维持）[12]指导的混合有效性-实施设计[11]。由于最初的 RCT 表明了家庭护理决策支持干预的功效，这一设计将焦点转移到更广泛的现实世界环境中的实施和有效性[11]。本研究侧重于干预在各国的影响（有效性），在必要时适应当地情况，采用单组前后测试设计。根据当地指南，每个参与国家都获得了伦理批准。参与者在参与之前提供了书面知情同意。我们使用 SQUIRE（2.0）指南来构建这份报告[13]，并使用 TIDieR 清单来报告干预[14]。

Context 上下文

Setting 设置

Data were collected between November 2020 and May 2022 (during the COVID-19 pandemic) in the six countries of the mySupport study consortium: Canada, Czech Republic, Ireland, Italy, the Netherlands and the UK. In each country, two nursing homes were recruited with exception of the UK where six nursing homes were recruited (two in three different regions). Due to study drop-out, two nursing homes were finally included in the UK. Nursing homes were defined as long-term care facilities providing 24-hour nursing care. We specifically recruited nursing homes that provided care to people with dementia.
数据收集时间为 2020 年 11 月至 2022 年 5 月（在 COVID-19 大流行期间），在 mySupport 研究联盟的六个国家进行了数据收集：加拿大、捷克共和国、爱尔兰、意大利、荷兰和英国。在每个国家，招募了两家养老院，英国除外，英国招募了六家养老院（在三个不同地区各两家）。由于研究退出，最终英国纳入了两家养老院。养老院被定义为提供 24 小时护理的长期护理设施。我们特别招募了为患有痴呆症的人提供护理的养老院。

Population 人口

The study’s target group were family caregivers of nursing home residents with advanced dementia (that is: residents who were unable to contribute to care conversations according to documented capacity assessments in the residents’ charts or the clinical judgement of the nursing home team). Family caregivers were 18 years or older, the primary family caregiver, and were able to understand and speak the local language. We aimed for a minimum of 10 family caregivers per nursing home (20 per country) as this allowed for analyses of the collective data [6] that is balanced across countries.
该研究的目标群体是护理院居民的家庭照顾者，这些居民患有晚期痴呆症（即：根据居民档案中的容量评估或护理院团队的临床判断，无法参与护理对话的居民）。家庭照顾者年龄需在 18 岁及以上，是主要的家庭照顾者，并且能够理解和说当地的语言。我们的目标是每个护理院至少有 10 名家庭照顾者（每个国家 20 名），这样可以进行跨国家的集体数据分析[6]。

Recruitment 招聘

Eligible family caregivers were identified by nursing home staff and if agreed, contacted by the research team. After being presented an overview of the study, they were sent study information and an informed consent sheet.
符合条件的家庭照料者由养老院工作人员识别，如果同意，将由研究团队联系。在介绍了研究概况后，他们将收到研究信息和知情同意书。

Intervention 干预

The previously developed Family Carer Decision Support [6] intervention was implemented in participating nursing homes. The intervention aims to inform family caregivers about end-of-life care options for people with advanced dementia to support them in end-of-life care decision-making. This reflects a broader definition of ‘advance care planning’ in dementia, including family caregiver engagement in advance care planning as proxy for the person with dementia who does not have the capacity to partake [15]. The intervention was adapted for implementation across countries by the international consortium [7, 16, 17]. A full description of the intervention has been published before [7]. In short, the intervention consisted of the following elements (Supplementary Figure S1).
先前开发的家庭照顾者决策支持[6]干预措施已在参与的养老院实施。该干预旨在告知家庭照顾者有关晚期痴呆症患者的临终护理选择，以支持他们在临终护理决策中的作用。这反映了对痴呆症中“预先护理规划”的更广泛定义，包括家庭照顾者参与预先护理规划，代表无能力参与的痴呆症患者[15]。该干预措施已由国际财团[7, 16, 17]调整以在各国实施。干预措施的完整描述已在之前发表[7]。简而言之，该干预措施包括以下元素（附图 S1）。

Educational family booklet and question prompt list
教育家庭手册和问题提示列表

Family caregivers received an educational booklet about comfort care for people with dementia at the end of life [17, 18]. The booklet discusses the dementia trajectory, possible symptoms and complications, shared decision-making, palliative care options and the dying phase and grief. In each country, we developed a question prompt list together with family caregivers (as part of our Patient and Public Involvement strategy) [16]. This list of sample questions served as a conversation aid for family caregivers during a meeting with a nursing home staff member.
家庭照顾者在生命终期收到了一本关于为患有痴呆症的人提供舒适护理的教育手册[17, 18]。该手册讨论了痴呆症的发展轨迹、可能的症状和并发症、共同决策、姑息护理选择以及临终阶段和悲伤。在每个国家，我们与家庭照顾者一起制定了一个问题提示列表（作为我们的患者和公众参与策略的一部分）[16]。这个样本问题列表作为家庭照顾者与养老院工作人员会面时的对话辅助工具。

Training and facilitation
培训和促进

In the original intervention, a facilitator external to the nursing homes was trained in conducting family care conferences. In the current study, a train-the-trainer model was implemented, involving external and internal facilitators. One or two external facilitators were trained per country, who then trained nursing home staff members in conducting family care conferences. In each participating nursing home, one to five nursing home staff members were trained as internal facilitators. Their professions ranged from nurse aide, nurse assistant, nurse, head nurse/clinical nurse unit manager, social worker, and nurse educator or nursing home manager.
在最初的干预中，护理院外部的促进者接受了家庭护理会议的培训。在当前的研究中，实施了培训师培训模式，涉及外部和内部促进者。每个国家培训了一到两名外部促进者，然后他们培训护理院工作人员进行家庭护理会议。在每个参与的护理院中，培训了一到五名护理院工作人员作为内部促进者。他们的职业范围包括护理助理、护理助手、护士、护士长/临床护士单位经理、社会工作者、护士教育者或护理院经理。

Family care conference 家庭护理会议

The family care conference was a structured meeting of ~1 hour. The internal facilitator discussed the contents of the educational booklet, which the family caregiver had reviewed prior to the meeting, and any questions the family caregiver wanted to discuss. The aim was to inform and support family caregivers. The possibility of advance decisions and follow-up meetings were discussed.
家庭照顾会议是一个大约 1 小时的结构化会议。内部主持人讨论了教育手册的内容，这是家庭照顾者在会议之前已经审阅过的，并回答了家庭照顾者想要讨论的任何问题。旨在为家庭照顾者提供信息和支持。还讨论了提前决定和后续会议的可能性。

Measures 措施

Baseline assessments of primary outcomes took place before the family care conference (pre-implementation); secondary outcomes reflected the 3 months prior to the family care conference. Follow-up assessment of primary outcomes took place 6 weeks after the family care conference (post-implementation); secondary outcomes reflected the 3 months after the family care conference (Supplementary Figure S2).
主要结果的基线评估在家庭护理会议之前进行（实施前）；次要结果反映了家庭护理会议之前的 3 个月。主要结果的后续评估在家庭护理会议之后 6 周进行（实施后）；次要结果反映了家庭护理会议之后的 3 个月（附图 S2）。

Standardised surveys were used to assess the primary outcomes. The impact of the intervention on family caregivers’ decision-making uncertainty and satisfaction with care was measured with the Decisional Conflict Scale (DCS) and Family Perceptions of Care Scale (FPCS), respectively. The DCS consists of 16 items that are scored on a 5-point Likert scale, with a reported reliability of 0.78–0.92 for the total scale [19, 20]. The scale measures uncertainty and factors contributing to uncertainty and effective decision-making in five domains: (i) feeling informed; (ii) feeling clear about values that guide the decision; (iii) feeling supported in decision-making; (iv) feeling certain about choosing and (v) making an effective decision. Scores for the five domains were calculated, and a total score reflecting overall decisional conflict. Family caregivers were instructed to consider any decision that was made or discussed recently or to answer the questions ‘when considering their family member’s preferences of future care’. The FPCS consists of 25 items that are scored on a 7-point Likert scale [21]. The original scale measures perceptions of care provided in the last 4 weeks of life. To assess perception of care before and after the intervention, we adapted the scale with rephrased statements to assess perception of care during the resident’s stay [6]. We calculated a total score and scores for four subscales: (i) resident care; (ii) family support; (iii) communication and (iv) rooming. Additionally, family caregivers were asked about their gender, age, educational attainment, employment status and relationship to the resident.
标准化调查被用来评估主要结果。干预对家庭照顾者的决策不确定性和对护理满意度的影响分别用决策冲突量表（DCS）和家庭护理感知量表（FPCS）来衡量。DCS 包括 16 个项目，按照 5 点李克特量表评分，总量表的可靠性报告为 0.78-0.92 [19, 20]。该量表衡量了五个领域中的不确定性和导致不确定性以及有效决策的因素：（i）感到被告知；（ii）对指导决策的价值感到清晰；（iii）在决策中得到支持；（iv）对选择感到确定；（v）做出有效决策。计算了五个领域的得分，以及反映整体决策冲突的总分。家庭照顾者被要求考虑最近做出或讨论的任何决定，或回答“在考虑家庭成员未来护理偏好时”的问题。FPCS 包括 25 个项目，按照 7 点李克特量表评分[21]。原始量表衡量了生命最后 4 周提供的护理感知。 为了评估干预前后对护理的感知，我们改编了一份量表，重新表述了一些陈述，以评估居民住院期间对护理的感知[6]。我们计算了总分和四个子量表的分数：（i）居民护理；（ii）家庭支持；（iii）沟通；和（iv）住房。此外，还询问了家庭照顾者的性别、年龄、教育程度、就业状况和与居民的关系。

The secondary outcomes, hospitalisations and documented advance decisions, were retrospectively obtained via chart review or reported by nursing home staff on a data extraction form that was designed and standardised for use across countries. The form included the location of death in case residents had died during the study within 3 months of the family care conference. Furthermore, it included length of stay and dementia severity assessed with the Functional Assessment Staging Tool (FAST) [22].
次要结果、住院情况和已记录的预先决策是通过图表审查或由养老院工作人员报告的，使用了为跨国使用而设计和标准化的数据提取表进行回顾性获取。该表格包括了死亡地点，以防居民在家庭护理会议后 3 个月内死亡。此外，它还包括了住院时间和使用功能评估分期工具（FAST）[22]评估的痴呆症严重程度。

All measures were translated into the local language using steps 1–4 of [23].
所有措施均使用[23]的 1-4 步骤翻译成当地语言。

The surveys were conducted via in-person interviews, by phone or videocall, via survey software or by pen-and-paper depending on participants’ preferences and possibilities considering COVID-19 regulations.
调查是通过面对面访谈、电话或视频通话、调查软件或纸笔方式进行的，具体取决于参与者的偏好和可能性，考虑到 COVID-19 的规定。

Analysis 分析

Family caregivers’ baseline characteristics were compared between those who completed all study phases and those who did not, using independent t-tests for age and Fisher’s exact chi-square tests for gender, educational level, employment status and relationship to the resident. For all further analyses, we included family caregivers (and their relatives with dementia) who had completed all study phases (pre-implementation baseline assessment (T0), intervention and post-implementation follow-up assessment (T1); per protocol analysis) as we were interested in measuring changes in response to the intervention. We performed descriptive statistics to report family caregivers’ and residents’ baseline characteristics. Differences between baseline and follow-up DCS and FPCS total scores and subscale scores were assessed using linear mixed models for repeated measures, with assessment time (baseline or follow-up) as fixed effect. To minimise type I errors, subscale scores were compared only when total scale scores differed significantly, and Bonferroni correction for multiple subscale comparisons was applied. We performed additional sensitivity analyses with covariate adjustment to reduce bias in effect estimates when outcome data are missing [24, 25], adding age, gender and FAST score measured at baseline as covariates [6, 24].
家庭照顾者的基线特征在完成所有研究阶段和未完成所有研究阶段的人员之间进行了比较，使用独立样本 t 检验比较年龄，使用 Fisher 精确卡方检验比较性别、教育水平、就业状况和与居民的关系。对于所有进一步的分析，我们包括完成所有研究阶段（实施前基线评估（T0）、干预和实施后随访评估（T1）；按照方案分析）的家庭照顾者（及其患有痴呆症的亲属），因为我们对测量对干预的反应的变化感兴趣。我们进行了描述性统计，报告了家庭照顾者和居民的基线特征。使用线性混合模型进行了基线和随访 DCS 和 FPCS 总分和子量表分数之间的差异分析，评估了重复测量的线性混合模型，评估时间（基线或随访）作为固定效应。为了最小化第一类错误，只有在总量表分数显著不同时，才比较子量表分数，并对多个子量表比较进行了 Bonferroni 校正。 我们进行了额外的敏感性分析，通过协变量调整来减少效应估计的偏差，当结果数据缺失时[24, 25]，添加年龄、性别和基线时测得的 FAST 评分作为协变量[6, 24]。

Documented advance decisions and actual hospitalisations were compared with McNemar tests for paired data and Bonferroni corrected for multiple comparisons. All analyses were performed using SPSS version 25.0 (IBM Corporation, New York, 2017).
记录的预先决策和实际住院情况进行了 McNemar 配对数据检验，并进行了 Bonferroni 校正以进行多重比较。所有分析均使用 SPSS 25.0 版进行（IBM 公司，2017 年，纽约）。

Results 结果

Reach and implementation
达成和实施

Across 12 nursing homes in 6 countries, 163 family caregivers were eligible for participation and 109 provided informed consent (Figure 1). Of the enrolled family caregivers, 88 (81%) completed all study phases. Complete cases did not differ significantly from incomplete cases in age, gender, employment status or relationship to the resident with dementia (all P > 0.05). A difference in educational level was found between the two groups (P = 0.04), with incomplete cases having higher educational levels.
在 6 个国家的 12 家养老院中，有 163 名家庭照顾者有资格参与，其中 109 名提供了知情同意（图 1）。在已注册的家庭照顾者中，有 88 人（81%）完成了所有研究阶段。完整案例在年龄、性别、就业状况或与患有痴呆症的居民的关系方面与不完整案例没有显著差异（所有 P > 0.05）。两组之间发现了教育水平的差异（P = 0.04），不完整案例的教育水平较高。

Two-thirds of the family caregivers were female, most (71/87) were children of the residents. The residents often (56/61) had moderately severe or severe dementia and were living in the nursing home for a median duration of 2 years and 1 month (Table 1).
家庭照顾者中有三分之二是女性，大多数（71/87）是居民的子女。居民经常（56/61）患有中度严重或严重的痴呆症，并且在养老院居住的中位时间为 2 年零 1 个月（表 1）。

Decisional conflict and perception of care
决策冲突和护理感知

DCS total and subscale scores were significantly lower at follow-up (T1) compared with baseline (T0), indicating less decisional conflict for family caregivers after receiving the intervention. In the sensitivity analyses adjusted for covariates, this difference remained. However, the differences in the subscales ‘Support’ and ‘Uncertainty’ were no longer significant (Table 2).
DCS 总分和子量表得分在随访（T1）时明显低于基线（T0），表明在接受干预后，家庭照护者的决策冲突减少。在对协变量进行调整的敏感性分析中，这种差异仍然存在。然而，子量表中“支持”和“不确定性”的差异不再显著（表 2）。

Similarly, FPCS total and subscale scores differed significantly between T0 and T1, indicating a more positive perception of care after the intervention. In the sensitivity analyses adjusted for covariates, the positive effects remained for the total score and the subscale scores ‘Family support’ and ‘Communication’ (Table 3).
同样，FPCS 的总分和分项分数在 T0 和 T1 之间有显著差异，表明干预后对护理的感知更为积极。在对协变量进行调整的敏感性分析中，总分和分项分数“家庭支持”和“沟通”的积极效果仍然存在（表 3）。

Advance decisions and actual hospitalisations
预先决策和实际住院

Table 4 shows that the number of documented advance decisions to refuse treatment (for example, do-not-intubate) was significantly higher after the intervention (32%) compared with before (24%). We did not find a difference in the number of other advance care plans, do-not-resuscitate orders or documented power of attorneys. Furthermore, we did not find a significant reduction in the number of hospital admissions after the intervention.
表 4 显示，干预后拒绝治疗的书面预先决定（例如，不进行插管）的数量明显高于干预前（32%比 24%）。我们没有发现其他预先护理计划、不复苏命令或书面授权委托的数量有所不同。此外，我们没有发现干预后住院人数有显著减少。

Seven residents died during the study: six after all assessments and in one case, the family caregiver participated in the follow-up assessment after their death. One resident died in the emergency department and four in the nursing home; for two residents, the location of death was not reported.
研究期间有七名居民死亡：六名在所有评估后死亡，在一个案例中，家庭照护者在其死亡后参与了后续评估。一名居民在急诊科死亡，四名在养老院死亡；有两名居民的死亡地点没有报告。

Discussion 讨论

After family caregivers across six countries had received the adapted Family Carer Decision Support intervention, they experienced less uncertainty in decision-making and were more satisfied with the nursing home care for their relative. We did not find a difference in the number of hospitalisations and advance decisions, except for the number of advance decisions to refuse treatment which was higher after the intervention. These transnational results are similar to the results from the RCT in Northern Ireland [6].
在六个国家的家庭照顾者接受了改编的家庭照顾者决策支持干预后，他们在决策过程中经历的不确定性减少了，并且对他们亲属在养老院的护理更加满意。我们并未发现在住院次数和预先决策方面有差异，除了干预后拒绝治疗的预先决策次数更高。这些跨国结果与北爱尔兰的随机对照试验结果相似[6]。

Family caregivers were more positive about the nursing home’s support of and communication with family caregivers after the intervention. In a Canadian study that implemented a multidimensional intervention to improve end-of-life care and comfort supported by an educational family booklet, FPCS scores improved through a more positive perception of the care provided to the residents [26]. Furthermore, family caregivers in our study reported less decisional conflict after the intervention, with the strongest effects on feeling informed and clear about values. These findings mirror the changes on the DCS found by others after implementing an educational intervention to support end-of-life care decision-making [27]. While the mySupport intervention impacted family caregivers’ perception of support from nursing home staff (as evident from the FPCS scores), the perception of support in decision-making specifically was not significantly impacted. Possibly, family caregivers perceive other family members as more important for decision-making support than nursing home staff (as also implied by others [28]). Future studies should investigate effects of including more (close) family members in conversations about future care.
家庭照顾者在干预后更积极地评价养老院对家庭照顾者的支持和沟通。在一项加拿大研究中，实施了一个多维干预措施来改善临终关怀和舒适度，支持教育家庭手册，FPCS 得分通过对对居民提供的护理更积极的感知而得到改善[26]。此外，我们研究中的家庭照顾者在干预后报告决策冲突减少，对信息和价值观清晰的影响最为显著。这些发现与其他人在实施教育干预支持临终关怀决策后发现的 DCS 变化相一致[27]。虽然 mySupport 干预影响了家庭照顾者对养老院工作人员支持的感知（从 FPCS 得分中可见），但对决策支持的感知并没有显著影响。可能家庭照顾者认为其他家庭成员在决策支持方面比养老院工作人员更重要（这也是其他人暗示的[28]）。 未来的研究应该调查包括更多（亲近的）家庭成员参与关于未来护理的对话的影响。

Regarding the impact on advance decisions and hospitalisations, no clear effect was found in the original RCT [6] nor in the current study. An umbrella review on advance care planning effectiveness reported some evidence for an increase in advance care planning documents and a decrease in hospitalisations [29]. In the current study, the number of hospitalisations was already low, leaving little room for reduction. The number of hospital admissions pre-covid was comparable to the number we found [30], but restrictions in hospital admissions during the COVID-19 pandemic [31] may have impacted our findings. Furthermore, the lack of a clear effect on the number of advance decisions may be related to local legislative frameworks. In the Netherlands, there is no clear distinction between ‘goals of care’ discussions and ‘advance care planning’; family caregivers can represent their relative in both. In Ireland and in some regions of Canada, advance care planning can only be legally performed by the person themselves, which is distinct from ‘goals of care’ discussions that can be conducted with proxies. The intervention may therefore have more impact on family caregivers’ preparedness for decisions they may need to make in the future, than on advance decisions. Changes in advance decisions and actual care may require interventions specifically targeting these outcomes in populations that have greater capacity to engage in documented advance care planning.
关于对预先决策和住院的影响，原始 RCT[6]和本研究均未发现明显影响。一项关于预先护理计划有效性的综述报告了一些证据，表明预先护理计划文件的增加和住院的减少[29]。在本研究中，住院人数已经很少，几乎没有减少的空间。 COVID-19 大流行前的住院人数与我们发现的数量相当[30]，但 COVID-19 大流行期间的住院限制[31]可能影响了我们的发现。此外，对预先决策数量的影响不明显可能与当地立法框架有关。在荷兰，'护理目标'讨论和'预先护理计划'之间没有明确的区别；家庭照护者可以代表他们的亲属参与两者。在爱尔兰和加拿大的一些地区，预先护理计划只能由本人合法执行，这与可以由代理人进行的'护理目标'讨论有所不同。 因此，干预可能对家庭照顾者未来可能需要做出的决定的准备更有影响，而不是对预先决策的影响。预先决策和实际护理的变化可能需要针对这些结果的干预，特别是针对那些有更大能力参与文档化预先护理规划的人群。

A strength of this study is the transnational setting that allowed assessment of whether findings from Northern Ireland (UK) generalise to other countries [32]. This study thus scales up previous findings, even during the COVID-19 pandemic. The study outcomes, less uncertainty in decision-making and more satisfaction with care resonate with family caregivers’ needs around the end of life: feeling prepared and supported while maintaining control of care [33], supporting the relevance of our findings. The sensitivity analyses indicate the findings’ robustness [25, 32]. Weaknesses of this study include the small sample size per country and the pretest–posttest design. The sample size per country was limited due to restricted access to nursing homes during COVID-19 and study dropout due to deaths, poor health of residents or family caregivers or other reasons common for this population [34]. Only in one country, the intended number of 20 participants was reached. It was therefore not possible to compare the outcomes between countries. Reporting data across countries may have masked intra-country differences and these are explored in forthcoming papers reporting on qualitative data. The study was conducted during the COVID-19 pandemic and restrictions varied during this time period. Participants’ responses may reflect influences other than the intervention, such as a more positive perception of communication with nursing home staff when visits were allowed [35], if visits were restricted during part of the data collection period. We cannot rule out contextual effects with a pretest–posttest design.
本研究的一个优势是跨国设置，这使得可以评估北爱尔兰（英国）的研究结果是否适用于其他国家[32]。因此，即使在 COVID-19 大流行期间，本研究也扩大了先前的发现。研究结果表明，在决策过程中减少了不确定性，对护理更满意，与家庭照料者在生命终结阶段的需求相一致：感到有所准备并得到支持，同时保持对护理的控制[33]，这支持了我们研究结果的相关性。敏感性分析表明了研究结果的稳健性[25, 32]。本研究的弱点包括每个国家的样本量较小以及前后测试设计。由于 COVID-19 期间对养老院的访问受限以及由于死亡、居民或家庭照料者健康状况不佳或其他常见原因而导致的研究退出，每个国家的样本量受到限制[34]。只有在一个国家达到了预期的 20 名参与者。因此，不可能比较各国之间的结果。跨国报告数据可能掩盖了国内差异，这些差异将在即将发布的定性数据报告中进行探讨。 该研究是在 COVID-19 大流行期间进行的，期间的限制措施各不相同。参与者的回应可能反映了干预之外的影响，比如在允许探访时对养老院工作人员沟通的更积极看法[35]，如果在数据收集期间的某个时段限制了探访。我们不能排除前后测试设计中的情境效应。

Our transnational findings provide evidence for the impact of structured conversations between family caregivers and trained nursing home staff, supported by written information, on family caregivers’ experiences of care and decision-making for residents with dementia. These findings may stimulate to incorporate communication training and education for nursing home staff about advance care planning, dementia and palliative care as core elements into curricula. Furthermore, nursing homes may be more encouraged to give information to family caregivers about dementia and palliative care, adapted to the local context, because of the demonstrated benefits of doing this. However, nursing home managers need to facilitate protected time for staff to communicate with families.
我们的跨国调查结果为结构化对话对家庭照顾者和受过培训的养老院工作人员之间的影响提供了证据，这种对话得到书面信息的支持，对家庭照顾者在照顾患有痴呆症的居民时的体验和决策产生了影响。这些发现可能会激发将沟通培训和教育纳入养老院工作人员的课程，涉及预先护理规划、痴呆症和姑息护理等核心要素。此外，由于这样做的益处已经得到证明，养老院可能更有动力向家庭照顾者提供有关痴呆症和姑息护理的信息，使其适应当地的情况。然而，养老院管理者需要为工作人员与家庭进行沟通提供保护时间。

Future studies may target larger participant groups per country and evaluate the intervention beyond the current European-Canadian setting. This may provide further insight into the influence of local culture on the effectiveness of the intervention.
未来的研究可能会针对每个国家更大的参与者群体，并评估干预措施超越当前的欧洲-加拿大环境。这可能会进一步揭示当地文化对干预措施有效性的影响。

Data Availability 数据可用性

Raw data (deidentified participant data) that support the findings of this study are available from the corresponding author, upon reasonable request.
本研究发现的原始数据（去标识化的参与者数据）可根据合理要求从通讯作者处获取。

Acknowledgements 致谢

We want to thank all family caregivers participating in the study. We also thank the external facilitators and internal facilitators who supported and delivered the intervention. Furthermore, we acknowledge the mySupport study group who contributed to the acquisition of data or overall study design: Jack Lawrence, Bianca Tétrault, Danielle Just, Donny Li, Diandra Serrano, Emily Di Sante, Karolina Vlckova, Alan Connolly, Selena O’Connell, Molly Mattsson, Silvia Gonella, Karen Harrison Dening, Kay de Vries, Josie Dixon, Catherine Henderson, Adrienne McCann, Sophie Morris, Julie Doherty, Emma Loudon, Andrew Harding, Emily Cousins.
我们要感谢所有参与研究的家庭照护者。我们还要感谢支持和实施干预措施的外部和内部促进者。此外，我们要感谢 mySupport 研究小组，他们对数据获取或整体研究设计做出了贡献：杰克·劳伦斯、比安卡·泰特罗、丹妮尔·贾斯特、唐尼·李、迪安德拉·塞拉诺、艾米丽·迪桑特、卡罗琳娜·弗尔科娃、艾伦·康诺利、塞琳娜·奥康奈尔、莫莉·马特森、席尔维亚·戈内拉、凯伦·哈里森·丹宁、凯·德弗里斯、乔西·迪克森、凯瑟琳·亨德森、艾德里安·麦肯、索菲·莫里斯、朱莉·多尔蒂、艾玛·劳顿、安德鲁·哈丁、艾米丽·卡辛斯。

Declaration of Conflicts of Interest
利益冲突声明

Prof Wilco Achterberg is an Associate Editor for Age and Ageing (care home section).
Prof Wilco Achterberg 是《年龄与衰老》（养老院部分）的副编辑。

Declaration of Sources of Funding
资金来源声明

This is an EU Joint Programme -Neurodegenerative Disease Research (JPND) project. This work was supported by the following funding organisations under the aegis of JPND -www.jpnd.eu: Canada, Canadian Institutes of Health Research [grant number 161462]; the Czech Republic, Ministry of Education, Youth and Sport [grant number 8F19005]; Netherlands, Netherlands Organisation for Health Research and Development [grant number 733051084]; Ireland, Health Research Board [grant number JPND-HSC-2018-002]; the United Kingdom, Alzheimer’s Society [grant number AS-IGF-17-001]. The funders played no role in the design, execution, analysis and interpretation of data, or writing of the study.
这是一个欧盟联合计划 - 神经退行性疾病研究（JPND）项目。该工作得到了以下资助机构的支持，这些机构在 JPND 的保护下运作 - www.jpnd.eu: 加拿大，加拿大卫生研究院[资助号码 161462]; 捷克共和国，教育、青年和体育部[资助号码 8F19005]; 荷兰，荷兰卫生研究与发展组织[资助号码 733051084]; 爱尔兰，卫生研究委员会[资助号码 JPND-HSC-2018-002]; 英国，阿尔茨海默病协会[资助号码 AS-IGF-17-001]。资助方在研究的设计、执行、分析和数据解释，以及研究的撰写过程中没有扮演任何角色。

References 参考资料