A randomized intervention study on the effects of telemonitoring in the aftercare of patients after cardiac surgery. A pilot

The average time of hospital admission after cardiac surgery, without a patient
being transferred to another hospital, is seven days, but depends on the
post-operative course. Once returned to their home situation, patients*
recovery is not always well. Questions and concerns may develop, which, if they
remain unanswered, hinder the process of recovery. Furthermore, the recognition
of symptons and complications is difficult for patients (Mistiaen, Francke &
Poot, 2007). The first weeks after discharge, especially with elderly people,
problems occur (Mistiaen & Poot, 2006).
A number of problems can lead to readmission within thirty days after
discharge, like: arrythmia, angina-pectoris, pleural fluid, pulmonary problems
and wound infections (Lahey, Campos, Jennings, Pawlow, Stokes & Levitsky, 1999;
Sun et al., 2008; Hannan et al., 2003; Theobald & McMurray, 2004). These
readmissions are burdensome for patients and their family, but also for the
health services. The percentage of readmission after a bypass surgery within
thirty days after discharge is between 6.3% and 12.9% (Sun et al., 2008; Hannan
et al., 2003).
Other problems that occur in the home situation are: sleep disorder, fatigue,
pain problems, shortness of breath and gastro-intestinal problems including
vomiting and constipation (Hartford, 2005; Theobald & McMurray, 2004). These
problems may affect the quality of life after cardiac surgery.
Within the Thoraxcentrum the patient is prepared for the surgery by the
Polyclinical pre-operative screening (PPOS). During PPOS the patient receives
information of different disciplines in a group and individually during a part
of a day. Following surgery the patient receives aftercare up to discharge from
a multidisciplinary team. After discharge the patient leaves this safe,
supported and intense controlled environment and goes home with limited control
and support up to the first check up with the cardiologist, approximately four
weeks after discharge.
Current aftercare consists of the advice to the patient to contact the general
practitioner in the case of problems. Commonly mentioned problems are: pain,
wound problems, cardiac arrythmia, re-admisisons connected to pleural fluid,
fatigue and lack of appetite. These complaints are also mentioned in the
literature.
Because of new developments in the area of information and communication
technology (ICT) the possibilities to monitor and support patients at a
distance by means of telemonitoring have risen. Studies up to now have
emphasized on patients with chronic illnesses such as cardiac dysfuntion,
Chronic Obstructive Pulmonary Disease (COPD) and diabetes mellitus (DM).
However, Tjalsma states that also patients suffering from non-chronic diseases
may profit from telemonitoring (Tjalsma, 2007).
The articles below are all related to patients with heart faillure. No research
has been done to the effects of telemonitoring with patients after cardiac
surgery.
In 2005 the TEN-HMS (The Trans-European Network-Home-care Management System)
study investigated the differences in effects of telemonitoring, contact by
telephone with a nurse and the usual aftercare with patients who recently were
discharged from hospital. Telemonitoring and contact by telephone seem to have
a decreasing effect on mortality, but do not contribute to a reduction of the
number of readmissions. However, in case of readmission a decreasing length of
stay is observed in comparison to the regular treatment (Cleland, Louis, Rigby,
Janssens & Balk, 2005). Schwarz, Mion, Hudock and Litman (2007) do not find an
improvement in quality of life or reduction of the number of readmissions. This
study only measured weight, but measuring only started maximum ten days after
discharge. The study proved to be safe, though (Schwarz, Mion, Hudock en
Litman, 2007). A randomized study with a population of 57 patients describes a
significant drop in the mortality and the number of re-admissions. However, it
did not find an improvement in the quality of life (Antonicelli et al.,2008).
Other studies, however, mention that telemonitoring directly after hospital
discharge do lead to a reduction of the number of re-admissions and improvement
if the quality of life (Cardozo & Steinberg, 2010; Polisena et al., 2010;
Woodend, Sherrard, Fraser, Stuewe, Cheung & Struthers, 2008). Not only is this
valid for patients with cardiac dysfunction, but also for patients with angina
pectoris complaints (Woodend et al.). Next to this, a high degree of patient
satisfaction is found in the use of telemonitoring, together with a greater
feeling of solidarity with health care (Cardozo et al.). Also Woodend et al.,
endorse the high degree of patient satisfaction. Even the patient group with
elderly people can in general easily operate the equipment (Woodend et al.).
The number of visits to a general practitioner and/or specialist increases,
however. The researchers attribute this to the more active role patients have
in their treatment with telemonitoring (Polisena et al.). Companies Achmea and
Philips tested the use of the Motiva telemonitoring system in a multicenter
study on patients with serious cardiac dysfunctions. The study shows that
patients are better informed about their illness, but does not show that the
use of this system prevents readmissions (Hartmotief studie, 2006). Health
insurance company Menzis investigated with KOALA (Kijken op Afstand, logisch
alternatief (Monitoring at Distance, logical alternative)) the possibilities of
another telecare system on the same group of patients in the north of Nederland
in 2006. This study does not measure quality of life. However, patients
experience a great degree of safety (Boonstra, Broekhuis, Offenbeek, Westerman,
Wijngaard & Wortmann, 2008).
To offer a patient optimum care, support and safety during the first four weeks
after discharge after cardiac surgery, a possibility lies in the use of
telemonitoring. This can be achieved by introducing telemonitoring in the
aftercare of patients who underwent cardiac surgery. Through telemonitoring it
can be recorded if quality of life improves and if complications are detected
early. Up to now, no study has been done in the support of patients after
cardiac surgery.

Four weeks after discharge what are the effects of telemonitoring with
patients after cardiac surgery on:
1. Quality of life (SF-36)

2. The number of readmissions within four weeks
3. The number of relevant complications:
atrial fibrillation
relapse angina pectoris
pneumonia
hypertension
dyspnoea
sternalwound infection/dehischention
leg- of arminfection/hematoma

The study method is a randomized intervention study. It concerns open
randomization with a parallel design. The study is a pilot study which will
take approximately 2 to 3 months.
Patients in the intervention group receive aftercare by means of
telemonitoring. The control group receives the normal aftercare.
The study is coordinated by Thoraxcentrum Twente, a division of Medisch
Spectrum Twente.

Patients in the intervention group receive aftercare by means of
telemonitoring. The control group receives the normal aftercare.
For telemonitoring patients measure their blood pressure and weight daily and
make an ECG weekly.
Current aftercare consists of the advice to the patient to contact the general
practitioner or the ward. After one month patients are called by the nurse of
the ward to be informed on their well-being.

Burden for the group with telemonitoring:
Measure blood pressure and weight daily and make an ECG weekly. With deviating
measurement results the patient is asked questions by the health monitor. Daily
burden: 10 minutes.
The control group does not have this burden.
Both groups are asked to fill out questionnaires.
Quality of life (SF-36):
The patients of the control group and the intervention group independently fill
out the quality of life (SF-36) questionnaire. First time at baseline (hospital
admission), second time four weeks after discharge. Burden: 9 minutes each time.
Complications and readmissions:
Four weeks after discharge during a phone call patients are interviewed if
there have been readmissions and/or complications. Results are recorded in a
list. Burden: 10 minutes.
Participation in the study has a negligible risk. It does not concern invasive
or medicinal intervention