Elsevier

The Lancet

Volume 392, Issue 10152, 22–28 September 2018, Pages 1047-1057
The Lancet

Articles
Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial

https://doi.org/10.1016/S0140-6736(18)31880-4Get rights and content

Summary

Background

Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.

Methods

The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed.

Findings

Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55–5·23) in the remote patient management group and 6·64% (6·19–7·13) in the usual care group (ratio 0·80, 95% CI 0·65–1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year compared with 24·2 days (22·6–26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21–13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50–0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45–1·01; p=0·0560).

Interpretation

The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.

Funding

German Federal Ministry of Education and Research.

Introduction

Telemedicine allows health-care providers to remotely diagnose and treat patients using telecommunications as either an alternative to or alongside in-person visits.1 Telemedicine has the potential to streamline and enable real-time consultation between caregivers through the same technology, to boost the provision of both timely and better-quality, personalised care for patients with chronic diagnoses.

Heart failure is a chronic disorder, the management of which could potentially benefit from a remote patient management approach.2, 3, 4, 5 One of the most challenging issues in the management of heart failure is to reduce hospital admission and readmission rates for worsening heart failure.2

Remote patient management includes a broad range of interventions, including uptitration of drugs in the outpatient setting, patient education, and management of comorbidities. This approach is an advance over telemonitoring alone, which generally focuses only on the early detection of clinical deterioration.

Research in context

Evidence before this study

We reviewed randomised and non-randomised studies and meta-analyses published up to Dec 31, 2017, that addressed or discussed the use of telemedicine in patients with heart failure. We searched PubMed with the search terms “telemedicine”, “remote monitoring”, “telemonitoring” and “heart failure”. We restricted the search to articles published in English and German. One randomised controlled trial (RCT) of invasive telemonitoring found a significantly lower rate of readmissions to hospital for heart failure resulting from remote patient management based on pulmonary artery pressure than with usual care. Another RCT measured multiple variables acquired remotely from implanted devices (implantable cardioverter defibrillator [ICD] or ICD plus cardiac resynchronisation therapy [CRT]) to manage patients with heart failure. This RCT showed a benefit in mortality for patients with heart failure with an indication for ICD or ICD plus CRT. On the basis of the results of these two RCTs, the 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure gave remote patient monitoring of patients with heart failure (with these two specific devices) a grade IIb recommendation, level of evidence B. No such recommendation exists for non-invasive remote patient management interventions. Within the past 10 years, non-invasive remote patient management strategies have been studied in several RCTs investigating the effect of remote patient management on mortality, morbidity, and quality of life in patients with heart failure. These RCTs have reported conflicting results because of major differences in the precise study populations investigated, the durations of the remote patient management interventions, the type of home-care devices used, and the interaction methods (including intensity and timing) between the patients, local physicians, heart failure specialists, and telemedical caregivers. Subgroup analyses of the TIM-HF trial suggested that remote patient management has a potential beneficial effect for patients with heart failure in functional New York Heart Association class II and III who were admitted to hospital for decompensated heart failure no more than 12 months before starting the remote patient management intervention and who did not have major depression, which is a common comorbidity in patients with heart failure.

Added value of this study

To the best of our knowledge, this is the first RCT to use a structured remote patient management intervention that was designed to be a true holistic approach for the management of patients with heart failure, involving cardiologists, general practitioners, nurses, other health-care providers, and the patient. The data transmitted to the telemedical centre was not just monitored; the Fontane system (telemedical analysis software) enabled the telemedical centre staff to provide tailored patient support and management using predefined algorithms and biomarker values obtained during follow-up visits. This approach enabled a risk profile to be defined for each patient and the subsequent individual patient care was tailored around this risk profile accordingly. Applying such a care concept, the telemedical centre was the central point for patient management, and such a unit requires physicians and heart failure nurses, and preferably a service that runs for 24 h a day, 7 days a week, and a modern information technology infrastructure, including a self-adapting software algorithm with prioritisation rules, to enable the tailored management of a large number of patients.

Implications of all the available evidence

Our study, along with findings from some of the previous RCTs, has shown that if a patient with heart failure is carefully chosen according to their profile (ie, they have had a recent admission to hospital for heart failure and do not show evidence of major depression) and a structured remote patient management intervention is used, the proportion of days lost due to unplanned cardiovascular hospital admissions or all-cause death during 1 year of follow-up is reduced compared with usual care. The key element in this holistic care concept is a telemedical centre with physicians and heart failure nurses available 24 h a day, every day, and able to act promptly according to the individual patient risk profile. The actions taken by the telemedical centre staff include changes in medication and admission to hospital, if needed, but also educational activities. Moreover, the study results were not influenced by geographical location. As a result, regional differences in the access to appropriate heart failure care might be reduced.

Over the past decade, several randomised studies investigating telehealth interventions in heart failure have been published.6, 7, 8, 9, 10, 11, 12, 13, 14 Because the finding of benefit for the interventions is inconsistent across these studies, and the interventions used were different in kind and intensity, the generalisability of the results for the management of heart failure is limited.15, 16, 17 As such, the recent European Society of Cardiology guidelines only give limited recommendations based on two device-related telemonitoring solutions.13, 14

Using data from the TIM-HF trial,10 we investigated which heart failure patient profile could potentially benefit from our multifaceted remote patient management intervention with respect to hospital admissions and mortality. In one of the prespecified subgroup analyses in the TIM-HF trial, we noted that patients assigned to remote patient management without major depression (ie, with a Patient Health Questionnaire [PHQ-9] score <10) who had recently been admitted to hospital for worsening heart failure, had fewer days lost due to hospital admission for heart failure or for all-cause death than did those who had usual care alone.18 Using these findings, we defined the heart failure patient population to be included in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial, which was undertaken to assess the effect of our remote patient management system on unplanned cardiovascular hospital admissions and mortality in this well defined heart failure population.19

Section snippets

Study design and participants

The TIM-HF2 trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Detailed methods are due to be published shortly.19 The trial was done in Germany, and patients were recruited from 200 university, local, and regional hospitals, and cardiology and general practitioner (GP) practices. Patients were eligible for inclusion if they had been admitted to hospital for

Results

Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned (796 to remote patient management plus usual care and 775 to usual care only, of which 765 in the remote patient management group and 773 in the usual care group were included in the full analysis set; figure 1). Baseline clinical and laboratory characteristics and the use of cardiovascular medications were similar between the two groups (table 1). The mean age of all patients was 70 years (SD 10), and 70% were men.

For

Discussion

The findings of TIM-HF2 show that remote patient management in a well defined heart failure population results in fewer days lost due to unplanned cardiovascular hospitalisations and all-cause mortality compared with the usual care group over a maximum follow-up of 393 days. The number of days lost was reduced from 24 days in the usual care group to 18 days in the remote patient management group. The primary outcome composite was driven mainly by reduction in mortality, and in particular

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