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.
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.
Other: Digital cardiac Counseling
Screening for reduced physical fitness and digital counseling.
Screening for smoking and digital counseling.
Screening for malnutrition and obesity and digital counseling.
Screening for anxiety and depression and digital counseling.
Screening for elevated pulmonary risk score and digital counseling.
Other Name: prehabilitation
Inclusion Criteria:
- Patients who are on the waiting list for any elective cardiac operation and are older
than 18 years old (adult cardiac surgery patients) during the Covid-19 pandemic
- Patients accepted for any elective cardiac operation and are older than 18 years
during the Covid-19 pandemic (adult cardiac surgery patients)
Exclusion Criteria:
- Patients who are not able to use digital platforms for various reasons (blindness,
illiteracy, neurological deficits, mental inability etc.)
- Patients who do not have an Internet connection or any digital platform and whose
direct family are not able to provide that.
Maastricht University Medical Center
Maastricht, Netherlands
Investigator: Peyman Sardari Nia, MD, PhD
Peyman Sardari Nia, MD, PhD
0031-433875070
peyman.sardarinia@mumc.nl
Jos Maessen, MD, PhD
0031-433875070
j.g.maessen@mumc.nl