The ICU-Recover Box: using smart technology for monitoring health status after ICU admission Pilot study 2.0

Approximately 80.000 critically ill patients are admitted to an intensive care
unit (ICU) in the Netherlands yearly (NICE) and this number is increasing. Due
to improved treatment techniques on
surgical wards and critical care facilities, the survival rate of critically
ill patients admitted to the ICU also rises rapidly. The standardized mortality
ratio was 0.92 in 2007 and 0.79 in 2020
(Stichting Nationale Intensive Care Evaluatie, NICE). This progress in ICU
medicine with respect to increased survival comes at a cost as many ICU
survivors are vulnerable and experience new
and long lasting physical, cognitive and mental health sequelae (e.g. PTSD,
depression, anxiety, acquired weakness), increased health care needs, increased
risk for hospital readmission and
death (Prescott et al. Crit Care Clin 2018; Shankar-Hari et al. Curr Infect Dis
Rep 2016). This impaired quality of life is summarized as the post intensive
care syndrome (PICS) by the Society of
Critical Care Medicine. (Capuzzo & Bianconi, 2015; Elliott et al., 2014;
Herridge & Cameron, 2013; Myers, Smith, Allen, & Kaplan, 2016; Needham et al.,
2012; Torgersen, Hole, Kvale, Wentzel-
Larsen, & Flaatten, 2011; Turnbull et al., 2016).
Around 30-63% of ICU survivors go on to experience high rates of health care
utilization and have to be readmitted to the hospital in the following year
after ICU and hospital discharge (DeMerle
et al. CCM 2017; Prescott et al. Crit Care Clin 2018; Prescott et al. JAMA
2015, Shankar-Hari et al. Curr Inf Dis Rep 2016). Furthermore, many of these
readmissions, approximately 40%
according to Prescott (Prescott et al. JAMA 2015), are for diagnoses that could
potentially be prevented or treated early to avoid hospitalization potentially.
These preventable causes, most
commonly included infection, heart failure exacerbation, acute renal failure,
chronic obstructive pulmonary disease exacerbation, and aspiration pneumonia.
Thus, to improve quality of care during ICU and hospital stay and after
hospital discharge, more knowledge of risk factors is needed to be able to take
preventive measures. And in addition to
addressing new disabilities, early outpatient care should focus on active
screening for and mitigating risk of common post-discharge problems (Prescott
et al. Crit Care Clin 2018; Prescott et alJAMA 2015). Also we need to know more
precisely the different trajectories that a post-ICU patient can experience,
because that also contributes to the ability to take preventive measures, early
recognition and treatment, all to prevent hospital readmissions and improve
quality of life and shift from unplanned to planable care. And knowledge of the
different trajectories has to include
multiple facets of patient-centered outcomes (i.e. physical, functional,
mental, cognitive) and their time course. And most importantly, we need to add
the above specificity to our prognostication
and should use detailed post-ICU information and should focus on
patient-centered outcomes when trying to prognosticate the future for post-ICU
patients.
And with increasing numbers of elderly, chronically ill patients we will only
be able to deliver affordable, high-quality and patient-centered care if we
adopt new ways of acquiring patient-specific
knowledge and new ways of delivering care. To obtain this level of insight we
need a smart and connected health care system. Today there are many examples of
applications that illustrate
connected health*s potential for improving access, quality and efficiency in
health care. They all involve the implementation of new technologies, including
remotely over the telephone and with
electronic interfaces, i.e. telemedicine and telehealth (Kvedar et al. Healtth
Affairs 2014, Wysham et al. Curr Opin Crit Care 2014).
Over the past (ten) years, smartphone compatible detectors of cardiovascular,
respirator
and other parameters have been released on the consumers market. Examples of
these
include heart rate monitors, ECG monitors, blood pressure monitors, activity
trackers, weight and fat percentages monitors. These monitors have often been
validated and are CE-marked for use
in the European Union within their intended use (Whithings,
https://www.withings.com/nl/en/for-professionals/devices).
Recent publications implicate that home monitoring with such consumer devices
might improve quality of care. A study by Bosworth et al. in patients with
hypertension showed that increased
monitoring and subsequent treatment led to a better controlled blood pressure
in patients who were treated for hypertension (Bosworth et al. Arch Intern Med
2011). Another study, carried out at
the LUMC, showed smart technology was feasible and yielded similar percentages
of patients with regulated BP compared with the standard of care after they had
a myocardial infarction
(Treskes et al JAMA 2020). For heart failure patients studies reported a
decrease in hospital readmission (Clark et al. BMJ 2007; Kulshreshtha et al.
Int J Telemed Appl. 2010) as well as no
difference in outcomes with home telemonitoring (Kulshreshtha et al. NEJM
2020). These results indicate the importance of a thorough independent
evaluation of telehealth strategies, for
different patient groups, in different phases of their illness, before their
adoption.
Currently, patients who have been admitted to the ICU are not seen in a
post-ICU outpatient clinic and there exists no other pathway of structured care
for ICU patients after their discharge, other
than extramural care initiated by patient themselves or scheduled visits to the
outpatient clinic. What we do know is that regularly post-ICU patients are
involved in a rehabilitation trajectory in
collaboration with rehabilitation specialists. Smart technology is hypothesized
to increase the chances of diagnosing physical (i.e. cardiovascular,
respiratory, neuromuscular), mental and
neurocognitive deterioration and may show a declining trend before a patient
visits the general practitioner or outpatient clinic, which can lead to early
detection and treatment before a patient
deteriorates and has to be readmitted to the hospital.

This study aims to determine feasibility of providing and following ICU
discharged patient with smart technology for 3 months after hospital discharge
from a general ward of the Leiden University
Medical Centre. If proven successful, home monitoring via smart technology will
be used in future studies.

• This is a single center cohort study.
• The duration of the study is four months: approximately one month for the
inclusion of the 15 patients, and three months follow-up.

The 2 smart devices used in this study for personal management are
non-invasive, easy to use, and electrically safe. Using the devices is without
risks. This study has some potential benefits for patients:
- first, patients can monitor their own recovery based on the measurements.
This can reassure patients and give them more insight into their own health
(the so-called 'patient empowerment'). A test subject is always responsible for
his/her health and will have to contact his/her GP or medical specialist at the
outpatient clinic if necessary, or with an emergency service.

There are several helplines for patients if they have questions about the
measurements, both technically and regarding interpretation of the
measurements. If outliers are identified in the data, the patient will be
called and advised to contact his/her GP or medical specialist.

A disadvantage of this study is that patients must perform one measurement per
day and a calibration of the blood pressure measurement once a month. In
addition, there is a half hour time commitment per month in the first 3 months
and then once every 3 months for a telephone interview using: a number of
questionnaires.
In addition, psychological strain can be caused by continuously measuring
health parameters, especially when the values **are irregular or not within the
normal range. We will record the frequency of the latter problem and hope to
resolve any mental health issues with all safety nets in place and will adjust
our future main protocol accordingly.
In summary, we believe this is a valuable study for post-ICU patients, with
almost no risks and some potential benefits for both participating patients and
future patients. We therefore believe that this research is ethically
responsible.