A randomized multicenter trial of a chronic disease management intervention for decompensated cirrhosis. The A ustra l ian L iver F a i lur e (ALFIE) trial.

The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA).

本试验的主要目的是评估慢性疾病管理（CDM）模式减少与肝脏相关的急诊入院（LREA）的效果。

The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes.

次要目标是评估模型对护理质量和患者报告结果的影响。

approach_and_results

The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care.

该研究设计为一项为期2年的多中心随机对照研究，采用1:1的比例分配临床决策支持模型与常规护理。

The study setting involved both tertiary and community care.

研究设置包括三级和社区护理。

Participants were randomly allocated following a decompensated cirrhosis admission.

参与者在失代偿性肝硬化入院后被随机分配。

The intervention was a multifaceted CDM model coordinated by a liver nurse.

干预措施是一种由肝病护士协调的多方面临床决策模型。

A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19.

共招募了147名参与者（干预组=75人，对照组=71人），他们的终末期肝病模型评分的中位数为19。

For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p =0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p =0.646).

主要结果方面，干预组与对照组的总体LREA发生率没有差异（发生率比为0.89；95%置信区间：0.53-1.50，p=0.666），或在实际生存率方面（风险比为1.14；95%置信区间：0.66-1.96，p=0.646）。

However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p =0.007).

然而，与对照组相比，干预组因脑病导致的LREA风险降低（风险比为1.87；95%置信区间：1.18-2.96，p=0.007）。

Significant improvement in quality-of-care measures was seen for the performance of bone density ( p <0.001), vitamin D testing ( p <0.001), and HCC surveillance adherence ( p =0.050).

在骨密度检测（p<0.001）、维生素D检测（p<0.001）和肝细胞癌（HCC）监测依从性（p=0.050）方面，观察到显著的护理质量改善。

For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale ( p =0.044).

在可评估的参与者中（干预组44/74，对照组32/71），3个月时患者自我管理能力和生活质量的显著改善，通过视觉模拟量表评估（p=0.044）。

Conclusions

This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.

这项临床数据管理干预措施并未减少总体LREA事件，对于失代偿性肝硬化患者，可能对于这个终点指标无效。