重症监护病房的家庭支持干预 (FICUS)
2026年6月23日 更新者：Rahel Naef
重症监护室基于指南的家庭支持干预的多中心、整群随机优势试验
背景：重症患者的家庭成员在他们的亲密他人的重症监护病房 (ICU) 住院期间面临相当大的不确定性和痛苦，大约 20-60% 的家庭成员在 ICU 后经历创伤后痛苦。 指南推荐结构化的家庭包容、沟通和支持，但围绕协议化家庭支持干预措施的现有证据基础有限，需要证实。
方法：为了测试临床有效性并探索在 ICU 中实施多组分、护士主导的家庭支持干预，研究人员将进行平行、整群随机、对照、多中心优势混合 1 型试验。 该试验将包括每个研究组的八个集群 (ICU)，预计总样本量为 896 名在瑞士德语区接受治疗的成年重症患者的家庭成员。 该试验的目标是预计在 ICU 停留 48 小时或更长时间的重症患者的家庭成员。 控制臂中的家庭将接受常规护理。 干预组中的家庭，除了常规护理外，还将接受家庭支持干预，包括在规定的时间点沿患者路径提供专科护士支持，包括后续护理、护士协调联络和结构化的跨专业沟通ICU团队。 主要研究终点是家庭护理的质量，以家庭成员出院时对 ICU 护理的满意度来衡量。 次要终点包括沟通和护士支持的质量、危重疾病的家庭管理（功能、恢复力），以及在入院、出院以及三个月、六个月和十二个月后测量的家庭成员的心理健康（幸福感、心理困扰） . 所有参与者的数据，无论协议遵守情况如何，都将使用线性混合效应模型进行分析，并将个体参与者作为推理单位。
讨论：FICUS 试验将确定家庭支持干预的有效性并产生关于其可实施性的知识。 两种类型的证据对于确定干预措施是否按预期在临床实践中起作用以及有效干预措施是否可以扩大到其他 ICU 都是必要的。 研究结果将对当前关于有效 ICU 护理的知识体系做出重大贡献，从而促进家庭参与和福祉。
研究概览
详细说明
背景：家庭成员对危重病人的健康和康复很重要，但他们自己也深受危重疾病的影响。 在重症监护病房 (ICU) 接受亲密他人治疗期间，家庭会经历高度的压力和不确定性，尤其是在代孕决策制定和失去亲人的情况下。 沟通不畅、共同决策不足以及重症监护人员的情感和实际支持不足已被发现增加了家庭的负担。 低质量的护理与不良的心理健康结果有关，据 20-60% 的家庭成员报告。 缺乏参与和支持，再加上巨大的压力，不仅会增加家庭的痛苦，还会影响家庭成员日常生活的功能，并限制他们参与危重疾病幸存者所需的照料活动或应对失去的能力。
理由：为了提高家庭护理的质量并防止不良的心理健康结果，ICU 指南建议家庭参与、沟通和支持以及特定角色的使用，但迄今为止这些建议的证据基础薄弱。 只有少数研究调查了由结构化沟通和/或特定家庭护理角色组成的家庭支持干预措施。 已经发现对家庭成员的沟通和支持经验有希望的影响。 然而，关于心理困扰的研究结果仍然没有定论，而关于家庭管理能力的见解几乎没有。 此外，围绕家庭参与 ICU 的最佳实践通常不会在常规护理中得到一致实施。 因此，需要通过随机对照设计产生的真实世界证据来确定此类多组分干预措施对家庭护理质量的影响及其在支持危重疾病家庭管理和减少不良心理健康结果方面的潜力。
目的：本研究旨在确定与向家庭成员提供的常规护理相比，基于指南、护士主导的跨专业家庭支持干预对家庭护理质量、家庭管理和个人心理健康的影响。 该研究还旨在确定实施研究干预的现实环境中的实施障碍/推动因素，以辨别实施成功的决定因素和策略。
方法：该试验设计为多中心、平行集群随机优势混合型 1 试验，每个研究组有 8 个集群，预计样本量为 896 名在德国急诊医院接受治疗的成年重症患者的家庭成员-瑞士的一部分。 它将针对有巨大需求的家庭成员，例如患有更复杂和持续时间更长的危重疾病的患者、因危及生命而入院的患者以及需要做出替代决定的患者。 需要短期围手术期或围介入 ICU 治疗的患者的家庭成员将被排除在外。 除了常规护理外，干预组的家庭还将获得 (1) 专科护士在规定的时间点沿着患者路径提供支持，从入院到出院以及随后的后续护理，以及 (2) 护士协调的联络和结构化，ICU团队的跨专业交流。 对照组的家庭成员将接受常规护理。 主要研究终点是家庭护理的质量，以家庭成员出院时对 ICU 护理的满意度来衡量。 次要终点包括沟通质量和护士支持、危重疾病的家庭管理（功能、恢复力），以及入院、出院以及 3、6 和 12 岁后获得的家庭成员心理健康指标（幸福感、心理压力）个月。 所有参与者的数据，无论协议遵守情况如何，都将使用线性混合效应模型进行分析，并将个体参与者作为推理单位。 混合方法研究将用于检查干预单位的实施障碍/促进因素和成功策略。
预期结果和影响：FICUS 试验将确定家庭支持干预的有效性，并产生有关有效实施过程的知识。 这两种类型的证据对于确定干预措施是否按预期起作用以及探索其在临床实践中的作用都是必要的，以便有效的干预措施可以扩大到其他 ICU。 研究结果将对当前关于有效 ICU 护理的知识体系做出重大贡献，从而促进家庭参与和福祉。 他们还将在 ICU 中推广循证家庭护理。
研究类型
介入性
注册 (实际的)
885
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Baden、瑞士
- Cantonal Hospital Baden
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Bern、瑞士
- Lindenhof-Hospital
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Bern、瑞士
- University Hospital Bern - Inselspital
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Chur、瑞士
- Cantonal Hospital Graubünden
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Frauenfeld、瑞士
- Spital Thurgau AG, Cantonal Hospital Frauenfeld
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Lucerne、瑞士
- Lucerne Cantonal Hospital
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Olten、瑞士
- Solothurn Hospitals AG, Cantonal Hospital Olten
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Sankt Gallen、瑞士
- Cantonal Hospital St. Gallen
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Thun、瑞士
- Hospital Thun
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Zurich、瑞士、8091
- University Hospital Zurich
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Zurich、瑞士
- Hirslanden Clinic Zurich
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Canton of Zurich
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Winterthur、Canton of Zurich、瑞士、8400
- Cantonal Hospital Winterthur
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
潜在参与者是入住研究 ICU 的重症患者的家庭成员。 从患者的角度来看，家庭成员被定义为亲密的其他人，如临床记录或预先指示中所述，或由法律定义的代理决策者指示。
关于患者（一名或多名）的纳入标准：
- 预期在 ICU 的停留时间≥48 小时，由入住 ICU 的临床医生（医生或护士）在入院时预测。
- 具有高死亡风险或长期功能障碍的危及生命的状况。
- 长时间机械通气（>24 小时）的高风险。
关于家庭成员的纳入标准（都必须适用）：
- 患者的主要支持者。
- 能够用德语完成家庭报告的结果测量（问卷）。
- 年龄≥18岁。
- 签署知情同意书。
关于患者的排除标准（一个导致排除）：
- 预先存在的拒绝普遍同意。
- ICU停留<24小时。
关于家庭成员的排除标准（一个导致排除）：
- 先前被纳入另一项研究 ICU 的 FICUS 试验。
- 认知上无法理解研究或完成临床医生和/或研究招募人员评估的问卷。
- 入院/研究注册后无法在规定的时间内完成基线数据收集（Calvert 等人，2018 年）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：家庭支持干预
干预组的家庭除了常规护理外还接受家庭支持干预
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除了常规护理外，干预组的家庭还将获得 (1) 专科护士在规定的时间点沿患者路径提供支持，从入院到出院，包括后续护理，以及 (2) 护士协调联络和结构化， ICU团队的跨专业交流。
该干预措施基于家庭系统方法和基于指南的 ICU 家庭参与策略，并已在一个 ICU 中进行了试点测试。
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无干预：日常护理
对照组的家庭将接受常规护理。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction With Care (Quality of Family Care) - Total Score
大体时间：Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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Quality of family care in ICU is operationalized as family satisfaction with ICU care, and measured with the Family Satisfaction in ICU questionnaire (FS-ICU-24R, German version).
The FS-ICU-24R is a well-established instrument that assesses satisfaction with care (16 items) and satisfaction with involvement in decision-making (ten items).
Its scores range from 0-100 with 100 indicating maximal satisfaction.
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Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Communication (Quality of Family Care) - Total Score
大体时间：Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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The Questionnaire on the Quality of Physician-Patient Interaction (QQPPI, original German version) is used to assess quality of communication between the ICU staff and family members during consultation.
The 14 items assess aspects such as relationship-building, information exchange, and shared decision-making.
The mean score ranges from 1-5 with a higher score indicating higher quality.
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Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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Nurse Cognitive and Emotional Support to Family (Quality of Family Care) - Total Score
大体时间：Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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The Iceland Family Perceived Support Questionnaire (ICE-FPSQ, German version) is used to measure families' perception of support provided by nurses.
The original English version has two subscales - emotional support (nine items) and cognitive support (five items).
The ICE-FPSQ has been translated into German and is currently being validated prior to its use in the trial.
A sum score is calculated for the total scale (range 14-70) and each subscale - emotional support (range 9-45) and cognitive support (range 5-25) - with higher scores indicating perception of better family support by nurses.
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Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
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Family Functioning (Family Management) - Mean Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Family Assessment Device - General Functioning Scale (FAD-GF-12, German version) - is used to assess overall functioning of the family system by six positive and six negative items.
The mean score ranges from 1-4 with a lower score reflecting better functioning.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Family Resilience (Family Management) - Mean Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Brief Resilience Scale (BRS, German version) measures the essence of resilience as the ability to bounce back from stress and is made up of three positive and three negative items.
The items will be reformulated from "I" to "we" statements to assess the families' ability to bounce back from stress.
The mean score ranges from 1-5 with a higher score indicating greater resilience.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Satisfaction With Life (Subjective Well-Being) - Total Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Satisfaction with Life Scale (SWLS-5, German version) measures the global dimension of subjective well-being.
The sum score ranges from 5-35 with a higher score indicating a higher degree of satisfaction.
It can be treated as an ordinal variable with seven levels using established thresholds.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Well-Being (Subjective Well-Being) - Total Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The World Health Organization-5 Well-being Index (WHO-5, German version) measures subjective psychological well-being and is made up of five items tapping three major dimensions of positive affect as well as energy within the past two weeks.
Its score ranges from 0-100, with a higher score indicating greater well-being, and has a threshold of 50 indicating depression.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Quality of Life (Subjective Well-Being) - Total Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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An adapted version of the general Quality of Life a Visual Analog Scale (QoL-VAS) as used in the EuroQol EQ-5D questionnaire will be employed to measure general rather than health-related quality of life.
The score ranges from 0-100 with a higher score representing higher quality of life.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Psychological Distress (Mental Health) - Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Distress Thermometer (DT, German version) is a validated single-item screening instrument for distress in the past week originally (and still primarily) used among cancer patients with an established threshold for potential distress It ranges from 0-100 with a higher score indicating a higher level of distress.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Anxiety (Mental Health) - Total Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 7 items related to anxiety (HADS-A subscale, seven items) - and has thresholds for mild anxiety and caseness for anxiety.
The scores range from 0-21 with a higher score indicating worse symptoms.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Depression (Mental Health) - Total Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 7 items related to depression (HADS-D subscale, seven items) - and has thresholds for mild depression and caseness for depression.
The scores range from 0-21 with a higher score indicating worse symptoms.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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Posttraumatic Stress (Mental Health) - Mean Score
大体时间：Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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The Impact of Events Scale-R (IES-R) measures the presence and severity of symptoms associated with a traumatic event during the past week, and has three subscales - intrusion, avoidance, and hyperarousal.
The six-item brief version (IES-6) used in this study includes two items from each of the three subscales, and its simple sum score (range 0-4 with a higher score indicating higher impact) has been shown to be highly correlated to the IES-R in various populations.
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Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Rahel Naef, PhD, RN、University of Zurich
- 首席研究员：Marie-Madlen Jeitziner, PhD, RN、University Hospital Bern, Inselspital
- 首席研究员：Miodrag Filipovic, MD、Cantonal Hospital of St. Gallen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Naef R, Filipovic M, Jeitziner MM, von Felten S, Safford J, Riguzzi M, Rufer M. A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial). Trials. 2022 Jun 27;23(1):533. doi: 10.1186/s13063-022-06454-y.
- Oesch S, Verweij L, Clack L, Finch T, Riguzzi M, Naef R. Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study). BMJ Open. 2023 Aug 8;13(8):e074142. doi: 10.1136/bmjopen-2023-074142.
- von Felten S, Filipovic M, Jeitziner MM, Verweij L, Riguzzi M, Naef R. Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial. Trials. 2024 Aug 28;25(1):568. doi: 10.1186/s13063-024-08351-y.
- Oesch S, Verweij L, Riguzzi M, Finch T, Naef R. Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation. J Adv Nurs. 2025 Nov;81(11):7245-7265. doi: 10.1111/jan.16544. Epub 2024 Oct 18.
- Walkling R, Verweij L, Oesch S, Naef R. Families' experiences with a novel nurse-led family support intervention in adult intensive care units: A qualitative thematic analysis. Intensive Crit Care Nurs. 2026 Feb;92:104248. doi: 10.1016/j.iccn.2025.104248. Epub 2025 Oct 10.
- Naef R, Jeitziner MM, Riguzzi M, von Felten S, Verweij L, Rufer M, Safford J, Sutter S, Bergmann-Kipfer B, Betschart U, Boltshauser S, Brulisauer N, Brunner C, Buhler PK, Burkhalter H, Dullenkopf A, Heise A, Hertler B, Hoffmann JE, Karde C, Keller Y, Kohler S, Lussmann F, Massarotto P, Moser M, Pietsch U, Segalada DL, Siegrist E, Steiger P, Ruch N, von Dach C, Wenzler MS, Wiegand J, Zante B, Filipovic M; FICUS Study Group. Nurse-Led Family Support Intervention for Families of Critically Ill Patients: The FICUS Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1138-1149. doi: 10.1001/jamainternmed.2025.3406.
- Verweij L, Oesch S, Naef R. Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis. BMC Health Serv Res. 2023 Dec 1;23(1):1339. doi: 10.1186/s12913-023-10285-1.
- Oesch S, Verweij L, Riguzzi M, Finch T, Clack L, Naef R. Integrating a family support intervention in intensive care units: A mixed-methods summative evaluation with health professionals. Int J Nurs Stud. 2026 Feb;174:105308. doi: 10.1016/j.ijnurstu.2025.105308. Epub 2025 Nov 29.
- Riguzzi M, Jeitziner MM, Rufer M, von Felten S, Verweij L, Oesch S, Sutter S, Safford J, Wenzler MS, Welter J, Wiegand J, Wiechmann D, von Dach C, Steiger P, Siegrist E, Ruch N, Pietsch U, Moser M, Massarotto P, Lussmann F, Keller Y, Hoffmann JE, Hertler B, Heise A, Dullenkopf A, Burkhalter H, Buhler PK, Brunner C, Brulhart D, Betschart U, Bergmann-Kipfer B, Filipovic M, Naef R; FICUS study group. The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes. Intensive Care Med. 2026 Apr;52(4):637-650. doi: 10.1007/s00134-026-08425-2. Epub 2026 May 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月12日
初级完成 (实际的)
2024年3月31日
研究完成 (实际的)
2025年1月2日
研究注册日期
首次提交
2022年2月20日
首先提交符合 QC 标准的
2022年3月4日
首次发布 (实际的)
2022年3月15日
研究记录更新
最后更新发布 (实际的)
2026年6月30日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.