Generally speaking, when telehealth makes the headlines, it is for positive reasons. Not a week goes by without seeing personal stories and videos of how telehealth has helped improve quality of life for people with long-term conditions. It is, therefore, surprising when a telehealth trial picks up disappointing or negative headlines, as in Forbes Magazine ('Why remote patient monitoring is overhyped'),1 as well as coverage in The New York Times ('Wired up at home to monitor illnesses')2 and the Los Angeles Times ('Heart patients not helped by phone monitoring as much as hoped').3
In this case, the lively discussion in the scientific media and popular press is about whether remote monitoring makes any difference to patient outcomes compared with usual care. The trial getting all the attention was carried out from 2006 to 2009 across 33 US cardiology practices under the organisation of the Yale University School of Medicine. The trial findings have now been reported in the highly respected New England Journal of Medicine (NEJM).4
The Tele-HF trial
In the Tele-HF report, 826 heart failure patients were randomly assigned to telemonitoring, with 826 on usual care. The 180-day telemonitoring approach was a telephone-based, interactive voice response (IVR) system that collected daily information on symptoms and weight for clinician review. Patients would call a toll-free phone number daily and respond with their phone keypad to the symptom questions. Clinicians reviewed the daily data and followed up patients where there were variances from protocols. Where patients did not use the telephone system for two consecutive days, they received a reminder, followed by staff calls when needed, to encourage participation.
At the 180-day trial end point, records were reviewed to identify re-admissions, in addition to patient interviews and other follow-ups, to ensure that there was a full picture for each patient. A committee of physicians looked at each potential re-admission to ensure that it was related to heart failure and not something else. Final interviews covered 79 per cent of patients.
The authors found that there was no reduction in the risk of re-admission or death from any cause with telemonitoring, compared with usual care. There were no reductions in the risk of hospitalisation for heart failure, the number of days in hospital, or the time to re-admission or death based on the six-month period. They suggest, in the journal article, that the findings appear to be out of step with the recent Cochrane Review on heart failure.5
Two more recent heart failure studies
Interestingly, two other recent studies present neutral findings when comparing telemonitoring with usual care. The first took place over three sites in the United States between 2002 and 2005, and the findings have only just been reported.6 This six-month, randomised controlled trial with a total of 315 heart failure patients found that there were no significant statistical differences between the intervention and control groups in respect of cardiac mortality, rehospitalisations or length of hospital stay. This trial had used an interactive, telephone-based, symptom response system with an electronic weighing scale for daily reports. Medical costs were higher for the monitoring arm compared with the usual care arm of the trial. The authors concluded that enhanced patient education and follow-up is as successful as the home monitoring device with an interactive programme, and less expensive.
The second of these other studies, from Germany, was discussed at the American Heart Association 2010 Scientific Sessions on 18 November 20107 along with the NEJM study, and prompted some interesting discussion.
The Telemedicine Interventional Monitoring in Heart Failure (TIM-HF) study involved 354 patients in the telemonitoring group and 356 people who had received usual care. There was no effect on the primary end point of death from any cause over the 24-month period, and no significant influence on secondary end points such as the composite of cardiovascular (CV) or heart failure (HF) hospitalisation. The intervention group showed a significant improvement in physical functioning and a trend to less depression.
According to 'The Heart' (www.theheart.org), Dr Stefan Anker, who led the German trial, suggested that remote monitoring was not for all patients with heart failure but could be used in clinically unstable patients as a 'bridge to stability', and should be explored in further trials for effectiveness in specific patient subgroups.
Although this trial has not been published, a further press release on the findings is now available.8
It is useful to look at the online analysis of some of these reports, particularly the Tele-HF report. The New England Journal of Medicine included some discussion of the Tele-HF report in an editorial and suggested that all of the elements of heart failure management must be included in home remote monitoring.9 Jon Linkous, Chief Executive Officer of the American Telemedicine Association (ATA), considered the trial findings in his blog10, and Neil Versel commented on the 20th century technology, the trial methodology, and also the low number of participants who were still monitored after six months.11
Some learning points
Published trial results with a neutral or negative finding can be as important to review as findings that are positive, and it is well worth looking at the available information on the Tele-HF and other trials. Here are a few areas worth looking at:
The technology and its use – The Tele-HF trial had taken steps to ensure that the systems, protocol, training, documentation and follow-up were in place to support the study participants. There are some discussion points about potential enhancements to their approach that could have improved effectiveness – eg, formal education for physicians, peer support, and more contact between clinicians and patients. It is vital to fully consider the role of the technology and the clinical support being used for remote home monitoring.
Non-participation and drop-outs – 14 per cent of telemonitoring patients never used the system. By the final week of the study period (180 days), only 55 per cent of patients were still using the system at least three times per week. The authors consider that these rates could be the best-case scenario because of the considerable trial resources. It is important to understand who could benefit from home monitoring and to regularly monitor use of the equipment. Although the equipment may be easy to set up initially, it can take time for some patients to understand the readings and change their behaviour to improve their quality of life and manage exacerbations. Non-use of the equipment, together with reasons for dropping out, need to be monitored and reviewed. The long-term, continued daily use of technology by patients is not yet fully understood. Care needs to be taken in reporting overall outcomes with significant loss rates.
Embedded in practice – The authors considered that telemonitoring strategy could be more effective if embedded in cardiology practice, compared to the ability to participate and the enthusiasm of the sites. They indicated that clinicians did not record data in a systematic manner. This was also picked up in the NEJM editorial on ‘connecting the circle’. An agreed protocol for all of the main stakeholders is vital – people need to know what is expected of them and how to respond. Telehealth is unlikely to succeed at scale unless firmly embedded within established care pathways.
Smaller-scale pilots – The Tele-HF study makes reference to an earlier, small, single-site trial where there was a significant reduction (44 per cent) in re-admissions, with associated cost savings. They were concerned, however, by the generalisability and scalability of this finding, as it had relied on a ‘single, highly skilled and motivated nurse case-manager’. The authors considered that previous claims of success based on studies with small populations of patients and methodological weaknesses are not supported by the results of their large, multi-centre trial. Small pilots may be helpful for patients and staff to understand how the technology works in practice, but do not prepare an organisation for working at scale. Many sites in England have struggled to get their telehealth installations beyond 20, 50 or 100 units, as major organisational transformations are needed to manage caseloads, handle data and monitor trends.
This article was taken from the Whole Systems Demonstrator Action Research Network (WSDAN) database
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- 2. Freudenheim M (2010). 'Wired up at home to monitor illnesses'. The New York Times. Available at: www.nytimes.com/2010/11/23/health/23monitor.html?_r=1 (accessed on 3 December 2010).
- 3. Maugh TH (2010). 'Heart patients not helped by phone monitoring as much as hoped'. Los Angeles Times.
- 4. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM (2010). 'Telemonitoring in patients with heart failure'. The New England Journal of Medicine. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1010029 (accessed on 3 December 2010).
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- 7. Stiles S (2010). 'No dent in readmissions, mortality seen with telemonitoring-guided HF care'. Available at: www.theheart.org/article/1151705.do (accessed on 3 December 2010).
- 8. 'Partnership for the Heart presents clinical study – Telemedicine helps risk patients live longer and with better quality of life'. Bosch.
- 9. Desai AS, Stevenson LW (2010). 'Connecting the circle from home to heart-failure disease management'. The New England Journal of Medicine editorial [online]. Available at: www.nejm.org/doi/full/10.1056/NEJMe1011769 (accessed on 7 December 2010).
- 10. Linkous J (2010). 'Remote cardiac monitoring: the debate begins'. American Telemedicine Association. Available at: http://americantelemed.blogspot.com/2010_11_01_archive.html (accessed on 3 December 2010).
- 11. Versel N (2010). 'Passive, telephone-based telemedicine is hardly common sense'. Fierce Mobile Healthcare, Editor’s Corner. Available at: www.fiercemobilehealthcare.com/story/passive-telephone-based-telemedicine-hardly-common-sense/2010-11-23 (accessed on 3 December 2010).