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Randomized Controlled Trial
. 2019 Apr 1;5(2):136-144.
doi: 10.1093/ehjqcco/qcy031.

Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study

Daniela Husser  1 , Johann Christoph Geller  2 , Miloš Taborsky  3 , Rolf Schomburg  4 , Frank Bode  5 , Jens Cosedis Nielsen  6 , Christoph Stellbrink  7 , Carsten Meincke  8 , Søren Pihlkjær Hjortshøj  9 , Jürgen Schrader  10 , Thorsten Lewalter  11 , Gerhard Hindricks  1
Affiliations
Randomized Controlled Trial

Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study

Daniela Husser et al. Eur Heart J Qual Care Clin Outcomes. .

Abstract

Aims: Randomized clinical trials investigating a possible outcome effect of remote monitoring in patients with implantable defibrillators have shown conflicting results. This study analyses the information flow and workflow details from the IN-TIME study and discusses whether differences of message content, information speed and completeness, and workflow may contribute to the heterogeneous results.

Methods and results: IN-TIME randomized 664 patients with an implantable cardioverter/defibrillator indication to daily remote monitoring vs. control. After 12 months, a composite clinical score and all-cause mortality were improved in the remote monitoring arm. Messages were received on 83.1% of out-of-hospital days. Daily transmissions were interrupted 2.3 times per patient-year for more than 3 days. During 1 year, absolute transmission success declined by 3.3%. Information on medical events was available after 1 day (3 days) in 83.1% (94.3%) of the cases. On all working days, a central monitoring unit informed investigators of protocol defined events. Investigators contacted patients with a median delay of 1 day and arranged follow-ups, the majority of which took place within 1 week of the event being available.

Conclusion: Only limited data on the information flow and workflow have been published from other studies which failed to improve outcome. However, a comparison of those data to IN-TIME suggest that the ability to see a patient early after clinical events may be inferior to the set-up in IN-TIME. These differences may be responsible for the heterogeneity found in clinical effectiveness of remote monitoring concepts.

Keywords: Defibrillator; Heart failure; Telemedicine; implantatble.

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Figures

Figure 1
Figure 1
Sketch of the remote monitoring information flow and interaction between parties in IN-TIME. CMU, clinical monitoring unit; HM, Home Monitoring.
Figure 2
Figure 2
Percentage of patients with home monitoring data transmission on any given day between randomization and study termination. Black line denotes the RM group and red line denotes the control group. The straight lines are the linear fits. The linear regression model shows that the decline was statistically significant in both groups (P < 0.001).
Figure 3
Figure 3
Increase of follow-ups after alerts. Based on 1222 alerts and 1289 follow-ups in 280 patients who had alerts in the RM group. We calculated the set of time intervals between each alert and all follow-ups following in the same patient. We show the relative number of follow-ups per day in the 8 weeks after the alert, as mean and standard deviation, normalized to the follow-up rate between 14 and 100 days after the alert. Note that the number of follow-ups is increased in the week after the alert, but not later. This suggests that most follow-ups resulting as a consequence of home monitoring information took place within a week of the alert.
Figure 4
Figure 4
Sketch of the IN-TIME information- and workflow with some performance characteristics. HM, Home Monitoring; Mo, Monday; Fr, Friday; Su, Sunday; FU, follow-up; asap, as soon as possible; n.a., not available; IQR, interquartile range.
See this image and copyright information in PMC

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