德国TIM-HF2试验中农村地区、就诊距离与心力衰竭患者远程患者管理的有效性:一项开放标签随机对照试验的预先指定分析

Rurality, travel distance, and effectiveness of remote patient management in patients with heart failure in the TIM-HF2 trial in Germany: a pre-specified analysis of an open-label, randomised controlled trial.

作者信息

Kerwagen Fabian, Störk Stefan, Koehler Kerstin, Vettorazzi Eik, Bauser Maximilian, Zernikow Jasmin, Barzen Gina, Hiddemann Meike, Gröschel Jan, Gross Michael, Melzer Christoph, Stangl Karl, Hindricks Gerhard, Koehler Friedrich, Winkler Sebastian, Spethmann Sebastian

机构信息

Department of Clinical Research and Epidemiology, Comprehensive Heart Failure Center, University Hospital Würzburg, Würzburg, Germany.

Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.

出版信息

Lancet Reg Health Eur. 2025 May 18;54:101321. doi: 10.1016/j.lanepe.2025.101321. eCollection 2025 Jul.

Abstract

BACKGROUND

Despite the higher burden of heart failure (HF) in rural areas, the accessibility of specialised HF care is limited when compared to urban areas. This study aimed to evaluate the impact of remote patient management (RPM) on clinical outcomes in heart failure patients, considering three different geospatial determinants.

METHODS

This was a pre-specified analysis of the TIM-HF2 (Telemedical Interventional Management in Heart Failure II) open-label, randomised trial, which compared the effects of an RPM intervention with care as usual in patients with HF hospitalisation within the last 12 months before randomisation. Patients were randomised in a 1:1 ratio to RPM or usual care. Additionally, randomisation employed a 2:1 ratio between rural and urban areas of medical care based on the location of the cardiologist. The primary endpoint was percentage of days lost due to all-cause death or unplanned cardiovascular hospitalisation, the secondary endpoints were all-cause and cardiovascular mortality. The current investigation focused on three key factors hypothesised to influence the effectiveness of the RPM intervention: the location of the cardiologist (rural vs. urban), the patient's place of residence (rural vs. urban), and the travel distance between these two locations. The TIM-HF2 trial was registered at ClinicalTrials.gov (NCT01878630) and has been completed.

FINDINGS

The TIM-HF2 trial was performed between August 13, 2013, and May 18, 2018. In the present analysis, all 1538 patients from the main trial were included; 915 (59%) of these were treated by a rural cardiologist, while 623 (41%) were treated by an urban cardiologist. The median travel distance was higher for patients living in rural than for those living in urban areas: 14.1 km (quartiles 4.3, 29.1) vs. 6.5 km (3.9, 13.8). The RPM intervention demonstrated a comparable reduction in the primary endpoint, irrespective of cardiologist location: rate ratio 0.82 (95% CI 0.62-1.08) for rural vs. 0.78 (0.55-1.09) for urban; or place of residence: 0.74 (0.55-0.99) for rural vs. 0.89 (0.65-1.22) for urban. The RPM intervention exhibited enhanced effectiveness at increasing travel distances, with a 13% risk reduction for each doubling of distance (2.2%-23.3%; p-interaction = 0.021). These distance-dependent effects were consistent for both secondary endpoints, i.e., all-cause (hazard ratio 0.75 [0.63-0.90]; p-interaction = 0.002) and cardiovascular mortality (0.77 [0.62-0.96]; p-interaction = 0.019).

INTERPRETATION

RPM, as deployed in the TIM-HF2 trial, was equally effective irrespective of the cardiologist's location. Patients living further from their cardiologist benefited the most from the RPM intervention. These findings suggest that greater emphasis should be placed on facilitating access to RPM for patients residing farther from specialized HF care.

FUNDING

Supported by the German Federal Ministry of Education and Research.

摘要

背景

尽管农村地区心力衰竭(HF)负担较重,但与城市地区相比,获得专业心力衰竭护理的机会有限。本研究旨在评估远程患者管理(RPM)对心力衰竭患者临床结局的影响,并考虑三种不同的地理空间决定因素。

方法

这是对TIM-HF2(心力衰竭II期远程医疗干预管理)开放标签随机试验的预先指定分析,该试验比较了RPM干预与常规护理对随机分组前12个月内有心力衰竭住院史患者的影响。患者按1:1比例随机分配至RPM组或常规护理组。此外,根据心脏病专家的所在地,随机分组在农村和城市医疗区域之间采用2:1的比例。主要终点是因全因死亡或非计划心血管住院导致的天数损失百分比,次要终点是全因死亡率和心血管死亡率。当前研究聚焦于三个假设会影响RPM干预效果的关键因素:心脏病专家的所在地(农村与城市)、患者的居住地(农村与城市)以及这两个地点之间的 travel 距离。TIM-HF2试验已在ClinicalTrials.gov(NCT01878630)注册并已完成。

研究结果

TIM-HF2试验于2013年8月13日至2018年5月18日进行。在本分析中,纳入了主要试验的所有1538例患者;其中915例(59%)由农村心脏病专家治疗,623例(41%)由城市心脏病专家治疗。居住在农村的患者的 travel 距离中位数高于城市患者:14.1公里(四分位数间距4.3,29.1)对6.5公里(3.9,13.8)。无论心脏病专家所在地如何,RPM干预在主要终点上显示出类似的降低:农村地区的率比为0.82(95%CI 0.62 - 1.08),城市地区为0.78(0.55 - 1.09);或居住地:农村地区为0.74(0.55 - 0.99),城市地区为0.89(0.65 - 1.22)。RPM干预在 travel 距离增加时显示出增强的效果,距离每增加一倍风险降低13%(2.2% - 23.3%;p交互作用 = 0.021)。这些与距离相关的效应在两个次要终点上均一致,即全因死亡率(风险比0.75 [0.63 - 0.90];p交互作用 = 0.002)和心血管死亡率(0.77 [0.62 - 0.96];p交互作用 = 0.019)。

解读

TIM-HF2试验中采用的RPM,无论心脏病专家的所在地如何,效果相同。居住距离心脏病专家较远的患者从RPM干预中获益最大。这些发现表明,应更加重视为居住在远离专业心力衰竭护理机构的患者提供RPM服务。

资金支持

由德国联邦教育与研究部提供支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af3/12266184/32fb98a6aaf5/gr1.jpg

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