Background & Aims

Individuals with cirrhosis discharged from hospital following acute decompensation are at high risk of new complications. This study aimed to assess the feasibility and potential clinical benefits of remote management of individuals with acutely decompensated cirrhosis using CirrhoCare®.

Methods

Individuals with cirrhosis with acute decompensation were followed up with CirrhoCare® and compared with contemporaneous matched controls, managed with standard follow-up. Commercially available monitoring devices were linked to the smartphone CirrhoCare® app, for daily recording of heart rate, blood pressure, weight, % body water, cognitive function (CyberLiver Animal Recognition Test [CL-ART] app), self-reported well-being, and intake of food, fluid, and alcohol. The app had 2-way patient–physician communication. Independent external adjudicators assessed the appropriateness of CirrhoCare®-based decisions.

Results

Twenty individuals with cirrhosis were recruited to CirrhoCare® (mean age 59 ± 10 years, 14 male, alcohol-related cirrhosis [80%], mean model for end-stage liver disease–sodium [MELD-Na] score 16.1 ± 4.2) and were not statistically different to 20 contemporaneous controls. Follow-up was 10.1 ± 2.4 weeks. Fifteen individuals showed good engagement (≥4 readings/week), 2 moderate (2–3/week), and 3 poor (<2/week). In a usability questionnaire, the median score was ≥9 for all questions. Five CirrhoCare®-managed individuals had 8 readmissions over a median of 5 (IQR 3.5–11) days, and none required hospitalisation for >14 days. Sixteen other CirrhoCare®-guided patient contacts were made, leading to clinical interventions that prevented further progression. Appropriateness was confirmed by adjudicators. Controls had 13 readmissions in 8 individuals, lasting a median of 7 (IQR 3–15) days with 4 admissions of >14 days. They had 6 unplanned paracenteses compared with 1 in the CirrhoCare® group.

Conclusions

This study demonstrates that CirrhoCare® is feasible for community management of individuals with decompensated cirrhosis with good engagement and clinically relevant alerts to new decompensating events. CirrhoCare®-managed individuals have fewer and shorter readmissions justifying larger controlled clinical trials.

Impact and implications

As the burden of cirrhosis grows worldwide, increasing demands are being placed on limited healthcare resources, necessitating the adoption of more sustainable care models that allow for at-home patient management. The CirrhoCare® management system was developed to fill this care gap, deploying a novel combination of hardware, apps, and algorithms, to monitor and intervene in individuals at risk of new decompensation. This study highlights the possibility of reducing hospital readmissions for cirrhosis by optimising specialist community care, reducing the need for interventions such as paracentesis, while providing a more sustainable care pathway that is acceptable to patients. However, given the pilot and non-randomised nature of this study, the outcomes require further validation in a larger randomised controlled trial, to assess both clinical effectiveness and cost-effectiveness. Moreover, the data generated will also facilitate data modelling and further research to refine the CirrhoCare® algorithms to increase their detection sensitivity and utility.

中文翻译：

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CirrhoCare® 的评估——一种用于肝硬化患者家庭管理的数字健康解决方案

背景与目标

急性失代偿后出院的肝硬化患者出现新并发症的风险很高。本研究旨在评估使用 CirrhoCare® 远程管理急性失代偿性肝硬化患者的可行性和潜在临床益处。

方法

患有急性失代偿的肝硬化患者接受了 CirrhoCare® 随访，并与同期匹配的对照组进行了比较，并进行了标准随访。市售监测设备与智能手机 CirrhoCare® 应用程序相关联，用于每天记录心率、血压、体重、身体水分百分比、认知功能（Cyber​​Liver 动物识别测试 [CL-ART] 应用程序）、自我报告的健康状况以及食物、液体和酒精的摄入量。该应用程序具有双向医患沟通。独立的外部评审员评估了基于 CirrhoCare® 的决策的适当性。

结果

20 名肝硬化患者被招募到 CirrhoCare®（平均年龄 59 ± 10 岁，14 名男性，酒精相关性肝硬化 [80%]，终末期肝病平均模型 - 钠 [MELD-Na] 评分 16.1 ± 4.2）和与 20 个同期对照没有统计学差异。随访时间为 10.1 ± 2.4 周。15 个人表现出良好的参与度（≥4 个读数/周），2 个中等（2-3/周）和 3 个较差（<2/周）。在可用性问卷中，所有问题的中位数得分均≥9。五名 CirrhoCare® 管理的个人在中位数 5 (IQR 3.5–11) 天内有 8 次再入院，没有人需要住院超过 14 天。在 CirrhoCare® 指导下与其他 16 位患者进行了接触，导致了阻止进一步进展的临床干预。评审员确认了适当性。对照组有 8 个人有 13 次再入院，持续时间中位数为 7（IQR 3-15）天，其中 4 次入院时间 >14 天。他们进行了 6 次计划外穿刺，而 CirrhoCare® 组为 1 次。

结论

这项研究表明，CirrhoCare® 对于失代偿性肝硬化患者的社区管理是可行的，具有良好的参与度和对新的失代偿事件的临床相关警报。CirrhoCare® 管理的个体的再入院次数更少且时间更短，这证明进行更大规模的对照临床试验是合理的。

影响和启示

随着全球范围内肝硬化负担的增加，对有限医疗资源的需求越来越大，因此有必要采用更可持续的护理模式，以便在家中进行患者管理。CirrhoCare® 管理系统旨在填补这一护理空白，部署硬件、应用程序和算法的新颖组合，以监控和干预有新失代偿风险的个人。这项研究强调了通过优化专科社区护理减少肝硬化再入院的可能性，减少对穿刺等干预措施的需求，同时提供患者可以接受的更可持续的护理途径。然而，鉴于这项研究的试点和非随机性质，结果需要在更大规模的随机对照试验中进一步验证，评估临床有效性和成本效益。此外，生成的数据还将促进数据建模和进一步研究，以改进 CirrhoCare ®算法，以提高其检测灵敏度和实用性。