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.

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.