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NIHR Signal Telemedicine programme can prolong life for heart failure patients

Published on 20 November 2018

doi: 10.3310/signal-000681

A comprehensive programme of daily telemedicine monitoring and 24-hour access to a physician-led hotline can reduce the number of deaths and the time spent in hospital, among patients with heart failure.

A year-long study of 1,571 patients who had been admitted to hospital with heart failure within the past 12 months found that those assigned to daily telemonitoring, monthly health education and telephone support from specialist staff, were 30% less likely to die than those assigned to usual care. This was a 3 percentage point reduction from 11% per year in the control group to 8% in the telemedicine group. This group also spent around a third fewer days in hospital.

This suggests telemedicine could make a real difference to patient outcomes for heart failure. The study was set in Germany and costs of the intervention may differ in the UK. So it would be useful to know how the programme compares to usual care in the UK before it is rolled out here.

Share your views on the research.

Why was this study needed?

An estimated 900,000 people in the UK live with heart failure, often alongside other co-morbidities, and unplanned hospitalisation is common. The numbers of newly-diagnosed patients have been rising.

Previous studies of telemedicine with the aim of reducing hospital admissions have been inconclusive and have tended to focus on the technology itself. This study aimed to evaluate the effects of a comprehensive telemedicine programme on a carefully-chosen group of people with heart failure. They all had worsening heart failure in the past 12 months requiring hospital admission, heart failure class 2 or 3 and a left ejection fraction less than 45% (or treated with oral diuretics). It did not include people scheduled for a heart procedure or those with depression, a common co-morbidity with heart failure.

What did this study do?

The TIM-HF2 randomised controlled trial included 1,571 people from 200 hospitals throughout Germany. Telemedicine was compared with usual care.

The 765 patients assigned to telemedicine care were provided with equipment to monitor daily body weight, blood pressure, heart rate, heart rhythm, peripheral capillary blood oxygen saturation and self-rated health status. A telemedicine centre reviewed patient data and could make adjustments to care or arrange for a patient to be seen or admitted if necessary.

Nurses also provided health education every month by telephone and patients had 24-hour emergency access to a doctor-led helpline. Outcomes were compared with 766 patients who received usual care over 12 months.

Patients in the telemedicine group were trained to use the equipment and may have been more motivated to take control of their heart failure than most.

What did it find?

  • There were fewer deaths in the telemedicine group: 8% in a year compared with 11% per year in the usual care group. This represented a 30% reduction in all-cause mortality (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.50 to 0.96).
  • Patients in the telemedicine group spent on average 3.8 days a year in hospital for unplanned admissions, compared with 5.6 days for the usual care group.
  • The primary outcome was a combination of days lost to either unplanned hospital admission or death from any cause. An average 17.8 days (95% confidence interval (CI) 16.6 to 19.1) were lost among the telemedicine group and 24.2 days (95% CI 22.6 to 26.0) were lost among the usual care group.
  • Although cardiovascular mortality was lower among the telemedicine group (5% compared to 8%), this did not meet statistical significance (HR 0.67, 95% CI 0.45 to 1.01).

What does current guidance say on this issue?

The 2018 NICE guideline on chronic heart failure in adults recommends people receive sufficient education and support if they wish to be involved in monitoring their condition. They should also be advised on what to do if their condition deteriorates. However, the use of telemedicine is not addressed.

The European Society for Cardiology’s 2016 guideline on diagnosis and treatment of heart failure states that management programmes for patients with heart failure after discharge from hospital should include regular clinic and/or home-based visits and possibly telephone support or remote monitoring.

What are the implications?

The study suggests that heart failure management through a comprehensive telemedicine package could improve mortality, although the potential costs of this in Germany are not reported. The intervention also appeared to reduce hospital stays. Lack of detail in the ‘usual care’ group means we cannot be sure how the study might translate to the UK. The intervention provides input from physicians and specialist nurses responding to patients and is likely to be high cost.

However, the results are persuasive and suggest that elements of telecare could be tested in UK heart failure treatment programmes. The cost and cost-effectiveness of a UK programme could also be evaluated. This is an area of interest for commissioners, general practitioners, community nurses and cardiology teams, as well as people with heart failure and their families, given the impact on quality of life and daily functioning.

Citation and Funding

Koehler F, Koehler K, Deckwart O et al. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018;392:1047-57.

The study was funded by a research grant from the German Federal Ministry of Education and Research.

Bibliography

Inglis  SC, Clark  RA, Dierckx  R et al. Structured telephone support or non‐invasive telemonitoring for patients with heart failure. Cochrane Database Syst Rev. 2015;10:CD007228.

NHS website. Heart failure. London: Department of Health; 2018.

NICE. Chronic heart failure in adults: diagnosis and management. NG106. London: National Institute for Health and Care Excellence; 2018.

Ponikowski P, Voors AA, Anker SD et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). European Heart Journal. 2016;37(27):2129–200.

Why was this study needed?

An estimated 900,000 people in the UK live with heart failure, often alongside other co-morbidities, and unplanned hospitalisation is common. The numbers of newly-diagnosed patients have been rising.

Previous studies of telemedicine with the aim of reducing hospital admissions have been inconclusive and have tended to focus on the technology itself. This study aimed to evaluate the effects of a comprehensive telemedicine programme on a carefully-chosen group of people with heart failure. They all had worsening heart failure in the past 12 months requiring hospital admission, heart failure class 2 or 3 and a left ejection fraction less than 45% (or treated with oral diuretics). It did not include people scheduled for a heart procedure or those with depression, a common co-morbidity with heart failure.

What did this study do?

The TIM-HF2 randomised controlled trial included 1,571 people from 200 hospitals throughout Germany. Telemedicine was compared with usual care.

The 765 patients assigned to telemedicine care were provided with equipment to monitor daily body weight, blood pressure, heart rate, heart rhythm, peripheral capillary blood oxygen saturation and self-rated health status. A telemedicine centre reviewed patient data and could make adjustments to care or arrange for a patient to be seen or admitted if necessary.

Nurses also provided health education every month by telephone and patients had 24-hour emergency access to a doctor-led helpline. Outcomes were compared with 766 patients who received usual care over 12 months.

Patients in the telemedicine group were trained to use the equipment and may have been more motivated to take control of their heart failure than most.

What did it find?

  • There were fewer deaths in the telemedicine group: 8% in a year compared with 11% per year in the usual care group. This represented a 30% reduction in all-cause mortality (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.50 to 0.96).
  • Patients in the telemedicine group spent on average 3.8 days a year in hospital for unplanned admissions, compared with 5.6 days for the usual care group.
  • The primary outcome was a combination of days lost to either unplanned hospital admission or death from any cause. An average 17.8 days (95% confidence interval (CI) 16.6 to 19.1) were lost among the telemedicine group and 24.2 days (95% CI 22.6 to 26.0) were lost among the usual care group.
  • Although cardiovascular mortality was lower among the telemedicine group (5% compared to 8%), this did not meet statistical significance (HR 0.67, 95% CI 0.45 to 1.01).

What does current guidance say on this issue?

The 2018 NICE guideline on chronic heart failure in adults recommends people receive sufficient education and support if they wish to be involved in monitoring their condition. They should also be advised on what to do if their condition deteriorates. However, the use of telemedicine is not addressed.

The European Society for Cardiology’s 2016 guideline on diagnosis and treatment of heart failure states that management programmes for patients with heart failure after discharge from hospital should include regular clinic and/or home-based visits and possibly telephone support or remote monitoring.

What are the implications?

The study suggests that heart failure management through a comprehensive telemedicine package could improve mortality, although the potential costs of this in Germany are not reported. The intervention also appeared to reduce hospital stays. Lack of detail in the ‘usual care’ group means we cannot be sure how the study might translate to the UK. The intervention provides input from physicians and specialist nurses responding to patients and is likely to be high cost.

However, the results are persuasive and suggest that elements of telecare could be tested in UK heart failure treatment programmes. The cost and cost-effectiveness of a UK programme could also be evaluated. This is an area of interest for commissioners, general practitioners, community nurses and cardiology teams, as well as people with heart failure and their families, given the impact on quality of life and daily functioning.

Citation and Funding

Koehler F, Koehler K, Deckwart O et al. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018;392:1047-57.

The study was funded by a research grant from the German Federal Ministry of Education and Research.

Bibliography

Inglis  SC, Clark  RA, Dierckx  R et al. Structured telephone support or non‐invasive telemonitoring for patients with heart failure. Cochrane Database Syst Rev. 2015;10:CD007228.

NHS website. Heart failure. London: Department of Health; 2018.

NICE. Chronic heart failure in adults: diagnosis and management. NG106. London: National Institute for Health and Care Excellence; 2018.

Ponikowski P, Voors AA, Anker SD et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). European Heart Journal. 2016;37(27):2129–200.

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

Published on 30 August 2018

Koehler, F.,Koehler, K.,Deckwart, O.,Prescher, S.,Wegscheider, K.,Kirwan, B. A.,Winkler, S.,Vettorazzi, E.,Bruch, L.,Oeff, M.,Zugck, C.,Doerr, G.,Naegele, H.,Stork, S.,Butter, C.,Sechtem, U.,Angermann, C.,Gola, G.,Prondzinsky, R.,Edelmann, F.,Spethmann, S.,Schellong, S. M.,Schulze, P. C.,Bauersachs, J.,Wellge, B.,Schoebel, C.,Tajsic, M.,Dreger, H.,Anker, S. D.,Stangl, K.

Lancet , 2018

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.

Heart failure classes describe how severe symptoms are, with class 1 being least severe and class 4 most severe:

Class 1 – no symptoms during normal physical activity

Class 2 – comfortable at rest, but normal physical activity triggers symptoms

Class 3 – comfortable at rest, but minor physical activity triggers symptoms

Class 4 – unable to carry out any physical activity without discomfort and may have symptoms even when resting

Expert commentary

This is an evaluation of a multi-faceted intervention that is much more broad-ranging than previous trials in heart failure that have come under the umbrella of ‘telehealth’. In addition to intensive telehealth monitoring, it includes a patient education programme, patient access to a 24/7 physician-led phone line, monthly telephone contact with a nurse, better integrated primary and secondary care, and a specific risk-based approach to individualised care.

No details are given of treatment provided in the ‘usual care’ arm, so it is difficult to determine the factors driving the impressive 30% reduction in all-cause mortality. No data on costs or cost-effectiveness were provided.

Nevertheless, the study provides an important signal that optimising heart failure monitoring and care can lead to important improvements in survival. This research should inform the development of new models of care for patients in the UK admitted to hospital because of their heart failure.

Jonathan Mant, Professor of Primary Care Research and Head of the Primary Care Unit, University of Cambridge

The commentator declares no conflicting interests.