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Remote patient management improves HF outcomes: TIM-HF2
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MUNICH — A structured remote patient management intervention for patients with HF reduced percentage of days lost from unplanned CV hospital admissions and all-cause mortality, according to data from the TIM-HF2 trial presented at the European Society of Cardiology Congress.
Friedrich Koehler, MD, FESC, head of the Centre for Cardiovascular Telemedicine at Charité–Universitätsmedizin Berlin, and colleagues wrote in The Lancet.
Remote management
The remote patient management intervention in TIM-HF2 consisted of daily transmission of vitals to a telemedical center, patient education, and direct communication between the telemedical center, the cardiologist and the general practitioner, all of whom were involved in the patient’s management.
The study utilized a noninvasive, multi-parameter telemonitor system installed in the patient’s home, which featured a three-channel ECG, BP-monitoring device and weighing scales, by which information was transferred remotely. Patients received a mobile phone to contact the telemedical center in case of emergency. Patients were also followed with monthly phone interviews. The telemedical center provided 24/7 physician-led medical support and patient management, which allowed physicians to act quickly to address a medication change, need for hospitalization or need for ambulatory assessment by a home physician, for example, and also permitted them to define risk categories for patients to prioritize and tailor care, according to Koehler.
“A well-structured telemedical center providing 24/7 service is a key element within the [remote patient management] intervention,” Koehler said here.
In this study, four physicians and five registered nurses comprised full-time daytime staff in the telemedical center, and one physician was on-call onsite and one physician on-call at home during the nightshift, according to details in The Lancet study.
Intervention showed benefit
The TIM-HF2 trial tested the intervention in 1,538 patients at various centers in Germany who were admitted to a hospital for worsening HF within the previous 12 months. Half of patients (n = 773) were randomly assigned to receive usual care in accordance with current HF guidelines and the other half (n = 765) to remote patient management plus usual care. Patients were followed for at least 1 year and up to 393 days after randomization.
The primary outcome of interest — percentage of days lost from unplanned CV hospital admissions or all-cause death — was 4.88% in the remote-management group vs. 6.64% in the usual-care group (rate ratio = 0.8; 95% CI, 0.65-1; P = .046), according to data presented.
The mean number of days lost from unplanned CV hospital admissions was 17.8 per year in the remote-management group vs. 24.2 in the usual-care group.
The researchers noted that the actions made by the telemedical center “indeed triggered a number of hospital admissions” in the remote-management group, they wrote in The Lancet. While total admissions were lower in the remote-management group, the researchers “speculate that the telemedicine center-triggered hospitalizations prevented hospital stays of longer duration.” Koehler and colleagues said future research is warranted to explore the nature, duration and effect of the hospitalizations that occurred during this study.
The rate of all-cause mortality was 7.86 per 100 person-years in the remote-management group vs. 11.35 per 100 person-years in the usual-care group (HR = 0.7; 95% CI, 0.5-0.96). The difference between both groups for CV mortality was not statistically significant (HR = 0.67; 95% CI, 0.45-1.01), according to the findings.
In other results, differences in changes in N-terminal pro-brain natriuretic peptide, mid-regional proadrenomedullin and Minnesota Living with Heart Failure scores were not significant.
The mean age of patients enrolled was 70 years and most were men. At baseline, all patients had a left ventricular ejection fraction of less than 45%, NYHA class II or III HF and were receiving treatment with diuretics. About 60% of patients were living in rural areas in Germany. – by Darlene Dobkowski
References:
Koehler F, et al. Late-Breaking Science in Telemedicine. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.
Koehler F, et al. Lancet. 2018;doi:10.1016/S0140-6736(18)31880-4.
Disclosures: The study was funded by the German Federal Ministry of Education and Research. Koehler reports he received research grants from German Federal Ministry of Education and Research and personal fees from Abbott, Medtronic and Novartis. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Mary Norine Walsh, MD, MACC
The TIM-HF2 trial is interesting. The use of telemedicine in HF has been studied extensively in past trials with very disparate results, most of them negative. Important considerations are: what population is studied; whether patients had just come out of the hospital; how many hospitalizations they had previously; and then the structure of the telemedicine approach — where the information goes, what the clinician does.
This study is very robust. Patients were identified appropriately, and the effort made to capture them in a disease management structure was enormous with all the technologies in place, but they also had clinicians — both primary care and cardiology — available 24/7. They also had a plan. They risk-assessed patients and then took specific action, so there was significant up-titration of medications.
The way this trial differs from previous telehealth studies that have not shown benefit is that there was action recommended for patient care. Previous trials provided biometric data to treating clinicians, but no action was stipulated.
This was a funded trial. How this approach can be rolled out to patient populations without similar funding is another question. This is a very labor-intensive approach, including having clinicians at the ready around the clock. The trial may give us an avenue forward to continue to explore telehealth.
St. Vincent Heart Center, Indianapolis
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