| Summary: | <strong>Objectives</strong> SUPPORT-HF 2 tests the hypothesis that home monitoring with IT-supported specialist management, is more effective in optimizing medical therapy than is home monitoring alone for patients with heart failure. <strong>Methods and Results</strong> The study was designed as a two-armed partially blinded parallel randomized controlled trial. Seven sites in the United Kingdom (UK) recruited a total of 202 adults with heart failure at high risk of adverse outcomes and with potential to benefit from remote management (mean age 73 years, 28% female, median left ventricular ejection fraction 37%). Both arms are given a home monitoring and communication kit (internet-enabled tablet computer, Bluetooth-enabled blood pressure and heart rate monitor and weighing scale). For each participant, an individualized plan for treatment of heart failure and major co-morbidities is developed before randomization. Participants randomized to intervention receive regular feedback to support self-management and their doctors receive advice on blood investigations and pharmacological treatment from a central specialist heart failure team. Participants in the control arm use the same monitoring system but with no central medical management support. The primary outcome is the use of recommended medical therapy, defined as treatment consistent with the guidelines for management of patients with chronic heart failure and will be measured as a composite opportunity score. The trial data collection ended in October 2017 and results will be reported in 2019. Trial registration: ISRCTN86212709. <strong>Conclusions</strong> Preliminary experience suggests that central provision of tailored specialist management using commercially available low-cost monitoring and computing devices, enhanced by customized applications, is feasible. In many healthcare systems, most patients with chronic heart failure are managed in primary care predominantly by physicians without specialist training for this condition, who often lack sufficient resources to adhere to recommendations on how to achieve target doses of disease-modifying treatments and monitor safety.1., 2. This together with the perceived complexity of disease management for an increasingly multi-morbid patient population often leads to reduced quality of care and poor patient outcomes.2., 3. Innovative models of care delivery that make better use of technological advances, in particular information technology (IT), may help overcome the challenges of chronic disease management for conditions such as heart failure.4., 5. IT can enable automation of repetitive clinical tasks, such as monitoring or patient education, potentially reducing costs. If successful in reducing the frequency of face-to-face interactions with healthcare professionals, such systems may also provide a more sustainable and scalable alternative to the prevailing labour-intensive and episodic models of care for patients with heart failure. Additionally, analytical techniques based on the recording of large amounts of multi-modal information through such systems might be used to improve the early prediction or early detection of clinical deterioration and to stratify treatment according to the patient's profile, ultimately leading to improved outcomes. However, despite the intuitive appeal of such systems, the evidence for their effectiveness is inconsistent.6., 7., 8., 9. This may be, in part, due to differences in patient-related features, intensity and type of intervention provided, or methodological differences between the clinical trials. To date, most studies have investigated the incremental value of remote monitoring and management of patients who already had medically optimized treatment.10., 11. Furthermore, most trials have focused on remote monitoring per se, with limited or no centralized decision support for specialist care provision. For instance, in the BEAT-HF trial the nurse-led patient education and self-management intervention did not fully integrate with physician care, which limited recommendations for active drug interventions.12 However, two trials that combined invasive monitoring techniques with rule-based management support showed significant improvements in patient outcomes.13., 14. Another issue with some of the earlier trials that employed non-invasive monitoring systems was the limited achieved patient adherence to the remote monitoring systems.12., 15. To overcome this critical issue, in an earlier phase of the SUPPORT-HF, we co-designed a user-friendly non-invasive home monitoring system with input from patients and their carers and showed the system to be effective in supporting heart failure patients to monitor their health status regularly, even when IT literacy was low, with little loss of adherence over time.16., 17. Despite no active medical intervention, patients found the system useful, mainly because of the reassurance and sense of connectivity that the monitoring system provided.18 Building on these studies, we designed a trial to evaluate the efficacy of an IT-supported system for remote specialist medical management and patient support. Here we report its design and the baseline characteristics of its participants. <strong>METHODS AND ANALYSIS.</strong> <strong>Study design</strong> SUPPORT-HF 2 is a multi-centre two-armed partially blinded parallel randomized controlled trial, with a run-in period of up to 2 weeks between screening and randomization. It is testing the hypothesis that in patients with heart failure, home monitoring with an integrated risk prediction and disease management service, which provides tailored alerts and advice to patients and clinical decision support to healthcare practitioners (general practitioners, nurses and hospital cardiologists) is more effective in optimizing medical therapy than home monitoring with the same monitoring equipment but without the use of the integrated data analysis and decision support service. Recruitment was initiated at 7 UK hospital sites and patient consent and follow-up took place in the participants' homes. Hospitals acted as study sites. However, potentially eligible participants were identified from hospital wards prior to discharge, cardiology outpatient clinics, general practitioners, or community heart failure nurse clinics, or by reviewing the hospital discharge lists and referral lists to community heart failure nurses. <strong>Study eligibility.</strong> Adults with a confirmed diagnosis of heart failure, irrespective of its underlying etiology, were eligible for recruitment, provided they were judged to have a clear potential to benefit from home monitoring and management and were at high risk of death or hospitalization (see Table 1 for full eligibility criteria). Patients with either preserved or reduced ejection fraction were eligible but a recruitment target of a 2:3 ratio of patients with preserved vs reduced ejection heart failure was recommended to each recruiting sites.
|
|---|