Optimization of the Management of COVID-19 Through Tailored Recommendations to the Citizens

The COVID-19 pandemic is raging in the world, including Quebec. As of May 22, 2020, more than
46,141 cases have been identified in Quebec, including 3,865 deaths. The virus causes
heterogeneous clinical manifestations. People may be asymptomatic, have mild to moderate
symptoms (cough, fever, myalgia), or a severe form requiring hospitalization and transfer to
intensive care units. In a small proportion of people, it can cause death. Health emergency
status was declared in Quebec on March 13, 2020 to allow the deployment of the measures
suggested by the Public Health Department (PHD). Different types of recommendations (general,
targeted, personalized and tailored) are available to optimize the prevention and management
of COVID-19. General interventions are aimed at the entire population (eg: washing hands,
keeping 2 meters apart). Targeted interventions target a vulnerable population (eg: patients
with diabetes, the elderly, etc.). Personalized interventions are addressed specifically to a
person, without necessarily being adapted to that person (eg: a general letter addressed to
an individual by his name written in the header). The appropriate intervention considers the
individual's reality (eg medical, environmental). Tailored interventions require a capacity
for dynamic analysis and evaluation of information but are generally more effective in
changing behavior (3). This evaluation also allows sorting of relevant information. Indeed,
during a pandemic, a citizen may have a perception of contradictory information or be
overloaded with information from different media. The tailored assessment allows citizens to
have a clearer message in their reality. As mentioned above, in the case of COVID-19, the
heterogeneity of symptom presentation implies different realities for each individual. In a
potentially large proportion of cases, people may be asymptomatic or have mild to moderate
flu-like symptoms. Thus, many infected people will not consult in the health network. It has
been estimated that there are 10 times more people infected than those who are screened.
Establishing a diagnosis of infected people is a key factor in ensuring a coherent
epidemiological watch at the PHD. It is an indicator to monitor deconfinement and predict the
second wave. COVID-19 infection is therefore a reportable disease. Moreover, diagnosing the
disease in individuals with low symptoms makes them aware of their risk of transmission, as
well as that of their contacts, so that they can adapt their behavior to the recommendations
of the PHD. In addition, medical monitoring is critical in some vulnerable people with
COVID-19. In fact, people aged 70 and / or suffering from certain chronic diseases (such as
high blood pressure, atherosclerotic heart disease, obesity and diabetes) are at greater risk
of developing the severe form of the disease. Citizens seem less inclined to consult their
doctors during this period of disruption in the network. The preventive recommendations for
these people, whether or not they have COVID-19, must be absolutely tailored in order to
provide health care. Stricter preventive containment measures can have a negative impact on
functional capacity or the risk of co-morbidities in this population due to changes in
healthy lifestyle habits. Providing recommendations tailored to their situation on these
habits (eg physical activity, healthy eating, sleep) could help reduce these negative
effects.

In order to improve the health and safety of the population, the investigators propose to
co-develop, with citizens, patient partners, clinicians, companies, managers, decision-makers
and representatives of the PHD, a citizen portal in order to produce appropriate
recommendations related to the COVID-19 status (positive or negative), the risk of
complications (severity of symptoms and medical history), the risk of contamination
(environmental prevalence of the disease) and the risks related to confinement. This portal
will be adapted to level 2 literacy and validated by usability tests. From questionnaires
self-administered to citizens, the tool will allow dynamic monitoring of symptoms related to
COVID-19, collaborate with the PHD to improve the epidemiological portrait of the situation
by identifying people who do not consult in the health system network and to bridge the gap
with their family doctor.

Objectives: 1) Evaluate the feasibility of an efficient collaborative system between the PHD,
citizens, patients and health professionals allowing the optimization of appropriate
recommendations in both prevention and detection during the COVID-19 pandemic; 2) Produce
recommendations concerning preventive behaviors related to COVID-19 tailored to the medical
and environmental reality of each citizen; 3) Compare the proportion of users complying with
the recommendations between those receiving tailored recommendations and those receiving
general recommendations; 4) Observe the evolution of the state of health of individuals in
real time by collecting socio-demographic, psychosocial and physiological data, including
symptoms related to COVID-19, and data from measures surrounding confinement to the using a
self-administered assessment tool.

Methodology:

Specification: This is a clinical intervention study of a cohort including a nested and
randomized double-blind experimental design, where the tailored recommendations will be
compared to the general recommendations. Population and sample: People aged 18 and over,
residing in the Quebec City area, will be solicited according to an advertising strategy and
different collaborations which will enable the access to a cohort of 1407 participants (as of
May 22, 2020).

Programming: This project will be designed in three parts. The first component consists of
co-developing a citizen portal including a secure database hosted on the PULSAR platform to
record the information of each participant including their current state of health (chronic
diseases, COVID-19 status, symptoms), their geographic location (postal code or dissemination
area) and their psycho-social situation. The second part consists of using the information
from the first part and analyzing them using a decision-making algorithm to propose
recommendations tailored to the reality of each person which will be dynamically updated
according to the evolution of the pandemic and the person's state of health. A measurement
will take place after 3 weeks of the procedure.

Statistical Analysis Plan: This analysis plan was developed in collaboration with
biostatisticians and epidemiologists from the VITAM Research Center. Being in the context of
a 1: 1 randomized trial with an intervention group and a control group, the investigators
calculated the number of individuals with a threshold of statistical significance of 5%.
According to DiMatteo et al., adherence to medical recommendations is 50% to 75% in the
general population. In order to be conservative, the investigators therefore assumed a 50%
membership ratio for the control group (general recommendations). The working hypothesis is
that individuals receiving adapted recommendations will adhere to the recommendations more
than those in the control group. Based on the above formula, the minimum required number of
people for each group varies with the effect size (the minimum difference to be able to
detect). In order to detect a minimum intergroup difference of effect of 10% (if any) in the
proportion of individuals complying with the recommendations, 514 individuals per group will
be needed. Descriptive analyzes will be performed to describe the sample. For continuous
quantitative variables, measures of central tendencies will be obtained and for categorical
variables, absolute and relative frequencies will be reported. The rate of compliance with
recommendations by intervention group as well as the prevalence of COVID19 status and
reportable disease will be calculated. The investigators will then proceed to a temporal
analysis by profile enumeration: the start of each time interval will be marked each time a
change in recommendation occurs. Given the exploratory nature of these analyzes the primary
outcome will be dichotomized (participants who follow the recommendations versus the others).
The difference in proportions will be calculated by time interval and then a
Cochrane-Armitage test will be done to test the time trend of compliance with the
recommendations in each of the intervention groups. All statistical analyzes will be
performed using SAS software version 9.4.

Recruitment: An existing portal, developed with patients over the past 2 years, will be
adapted for the purposes of the project (PULSAR). Collaboration with an already existent
public health project, the MAVIPAN project, will allow the recruitment of participants who
have already agreed to be contacted for other projects. The MAVIPAN questionnaire already
contains several socio-demographic information and on the physical and psychological health
of the participants. The other questions will be adapted from existing tools (clinical
diagnostic criteria for COVID-19, MADO, electronic questionnaires from the INSPQ, iCARE
questionnaire). All data will be hosted on PULSAR, a collaborative platform for research and
intervention in sustainable health, ensuring data security. A partnership with the PHD will
make it possible to harmonize collection tools according to national and international
standards to facilitate data collection and analysis.

Timeline: The platform will be launched in November 2020. Recruitment and data collection in
the context of the project will take place until April 2021.

Expected results and impact:

Primary: Improvement in the rate of compliance with the PHD recommendations based on the
iCARE study. Measurement of the number of exits and contacts (e.g .: vulnerable person going
out (danger for them) or positive COVID-19 person going out (danger for others), going to a
doctor vs staying at home, doing their own grocery shopping vs having it delivered, going to
work or staying at home, going out for sports (running, walking).

Secondary: 1. COVID-19 status (new cases diagnosed); improved data collected in the
population (Public Health); reduction in the burden in clinics (self-diagnosis) 2. Patient
health status: assessed by self-reported health questionnaires already integrated into the
PULSAR platform (Chronic disease; socio-demographic data; sleep; lifestyle habits; quality of
life; physiological data; negative effects linked to confinement and social distancing (e.g.
loss of functional capacity, negative impact on healthy lifestyles); related to
recommendations for vulnerable populations. The tailored recommendations will allow citizens
to receive precise information related to their medical condition and their environment, to
better understand the measures and to comply more closely with them. Being in the period of
deconfinement, reducing risky behavior can reduce the transmission and spread of COVID-19.
The data will be useful to front-line clinicians to optimize the management of COVID-19 by
having recommendations tailored to the medical condition of their patients. The PHD will
benefit from a more realistic portrait of the prevalence of symptoms related to COVID-19 and
optimize the use of its resources. In addition, this data will make it possible to make
recommendations related to reducing the risks associated with confinement for vulnerable
populations. The Vigie-COVID portal will remain after the pandemic to monitor epidemics but
can also be used to monitor vulnerable populations with chronic diseases. The link that
unites citizens, the PHD and health professionals will last, given the added value for the
health network.