Rationale:
Most patients undergoing a cardiovascular procedure need an ICU-bed during the
hospitalization and therefore it is possible that for the unforeseen future, because of
the Covid-19 crisis, many patients will stay on the waiting list for many months to come.
There are some studies showing an increased mortality associated with an increased
waiting time for the patients on the waiting list for an elective cardiac surgery.
However, there is no data on the evolution of the morbidity, the quality of life and the
symptomatology of the patients waiting for an elective operation. Also it is not clear
whether the period of waiting for an elective cardiovascular operation would impact the
morbidity or the mortality of the planned operation at later stage. Furthermore, there is
a plethora of studies on risk factors associated with the perioperative morbidity and
mortality in general. Therefore, the rationale of the current study is to evaluate
whether Digital Cardiac Counseling (DCC) would improve outcomes of the patients waiting
for an elective cardiac operation. At the DCC platform, there will be assessments of
cardiovascular symptoms, Covid-19 prevention for cardiovascular patients, smoking
cessation, anxiety relief, exercise stimulation, pulmonary rehabilitation and diet
adjustments. This will be done by means of questionnaires and E-consults. Investigators
start this project now because of two reasons. First, the prolonged waiting list due to
the Covid pandemic creates the opportunity to use this period for cardiac
prehabilitation. Second, it is only recently that the investigators got the possibility
to use a digital platform, which is ideal in this period of social distancing.
Objective:
Primary Objective:
- What is the effect of an interactive Digital Cardiac Counseling platform with
E-consulting on cumulative incidence of major adverse cardiovascular events (MACE)
at 1 year after the cardiac surgery compared to the control condition (no
interactive Digital Cardiac Counseling)?
Secondary Objective(s): - What is the effect of an interactive Digital Cardiac Counseling
platform with E-consulting on patient-measured outcomes during treatment delay due to the
Covid-19 pandemic measured just before, and 1 year after the cardiac surgery compared to
the control condition (no interactive Digital Cardiac Counseling)?
Study design:
Randomized controlled trial. The investigators will use random permuted block size if
technically feasible otherwise with random block sizes of 4, 6, and 8. The randomization
will be computer-based and will generate two groups. Both groups will get access to the
Digital Cardiac Counseling platform and both groups will complete the same set of
validated questionnaires at the same time intervals. The intervention groups will get
additional training modules and E-consulting based on the risk assessment retrieved from
the completed questionnaires.
Study population:
The patient population will include any adult patient on the waiting list for any
elective cardiovascular operation in MUMC (Maastricht University Medical Center) during
Covid-19 pandemic.
Intervention:
the intervention group will receive through the Digital Cardiac Counselling platform
different modules with E-counselling for risk factors evaluated in the questionnaires.The
digital counselling modules for intervention group are described below: -
Screening for reduced physical fitness. If there are signs for a decreased physical
condition we will refer the patient, after consultation, for a digital intake with
our physiotherapist. The patients then get access to a digital module with
information and videos of physical exercise training. The patient gets a trainings
schedule and the investigators will contact the patient after about 1 and 3 weeks to
check their progression and to give additional advice when needed.
Screening for smoking. If the patient smokes and is motivated to quit smoking, the
investigators will refer, after consultation, for a digital intake with one of our
stop smoking nurses. Then, a digital and telephone supported counselling will start
after an informed and shared decision making with the nurse. When needed, supportive
medication can be prescribed.
Screening for malnutrition and obesity. If there are signs of malnutrition
(MUST-score) or obesity (BMI >30) the investigators will refer the patient, after
consultation, for a digital intake with a dietician. The patients then get access to
a digital module with information about a healthy diet. The investigators will
contact the patient ever 2 weeks in case of malnutrition and every 4 weeks in case
of obesity. In the case of malnutrition the dietician can prescribe protein rich
nutrition supplements when needed.
Screening for anxiety and depression. If there are signs for anxiety and depression,
the investigators will refer the patient, after consultation, for a digital intake
with a psychological assistant. The patients then get access to a digital platform
with information and exercises. The psychological assistant will guide the patient
and will provide digital support after 1 and 3 weeks.
Screening for elevated pulmonary risk score. When patients have an elevated risk
score for adverse pulmonary complications (pulmonary risk score for cardiac surgery
patients questionnaire) the investigators will refer the patient, after
consultation, for a digital intake with our physiotherapist. The patients then get
access to a digital module with information and videos of pulmonary exercise
training. The investigators will send a inspiratory muscle trainer (IMT) to the
patient to perform daily exercises. The patient gets a trainings schedule and the
investigators will contact the patient after about 1 and 3 weeks to check their
progression and to give additional advice when needed.
Main study parameters/endpoints:
The primary endpoint is cumulative incidence of MACE (Major Adverse Cardiovascular
Events) at 1 year after cardiac surgery. The primary outcome is the difference in
percentage of patients that experienced Mace at 1-year follow-up postoperatively. The
investigators expect that approximately 20% of patients in the control group will
experience an event. The investigators will include 197 patients per group, or 394 in
total, to be able to have 80% power to detect a difference in MACE of 10% between groups
in favor of the intervention group, using an alpha of 0.05.