Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04359875 |
| Other study ID # |
2020-CD-COVIQuest (COVID-19) |
| Secondary ID |
2020-A01061-38 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2020 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital, Tours |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Following the announcement of the containment of the population due to the COVID-19 epidemic
on March 17, 2020 in France, a notable decrease in the number of consultations in general
practice was reported. Patients no longer contact their general practitioner, including those
with regular follow-up for one or more chronic conditions. This observation raised worries
since it could lead to delay or failure in detecting decompensations / complications of these
chronic conditions by a lack of recourse to care. Thus, an urgent message from the National
Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the
health professionals regarding the organization of care aside from COVID-19. The main
recommendation was "that the personal physician or the corresponding specialist should
contact the most fragile patients with chronic condition to ensure follow-up and detect any
risk of decompensation ".
Such fragile patients are in great numbers, up to more than 200 for an average general
practitioner. Therefore, although this recommendation is regarded as "essential in view of
the health needs of the population", it will prove quite difficult to follow without the help
of a skilled external assistance that can be quickly mobilized.
Description:
Following the announcement of the containment of the population due to the COVID-19 epidemic
on March 17, 2020 in France, a notable decrease in the number of consultations in general
practice was reported. Patients no longer contact their general practitioner, including those
with regular follow-up for one or more chronic conditions. This observation raised worries
since it could lead to delay or failure in detecting decompensations / complications of these
chronic conditions by a lack of recourse to care. Thus, an urgent message from the National
Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the
health professionals regarding the organization of care aside from COVID-19. The main
recommendation was "that the personal physician or the corresponding specialist should
contact the most fragile patients with chronic condition to ensure follow-up and detect any
risk of decompensation ".
Such fragile patients are in great numbers, up to more than 200 for an average general
practitioner. Therefore, although this recommendation is regarded as "essential in view of
the health needs of the population", it will prove quite difficult to follow without the help
of a skilled external assistance that can be quickly mobilized.
The COVIQUEST project is a cluster randomized trial in general practice designed to assess
the optimizationg of the screening and management of patients with chronic condition at risk
of decompensation through a collaboration between the general practitioner and a medical
student.
The trial will focus on patients wit cardiovascular conditions aged 70 or more and patients
with mental health conditions. These conditions are both highly prevalent in general practice
and both at risk of severe short-term complications.
Practices will be randomly assigned to a group (A or B). In group A, students will start by
contacting patients with cardiovascular conditions; in group B they will start by contacting
patients patients with mentral health conditions. The students will call these patients on
the phone and ask them specific questions about their health, their needs, and if they want
their general practitioner to call them back. The student will then transmit this information
to the general practitioner who will decide on the best care to offer the patient.
The primary outcome is defined as the occurrence of hospitalization during a one-month period
after the phone call. It will be collected by a second phone call from the medical student.
This time, all patients will be contacted, i.e. both patients with mental illness and
cardiovascular patients, whatever the group. Thus, patients allocated to the control groups
(i.e. patients with mental illness from group A and cardiovascular patients from group B)
will also benefit from the intervention at 1 month: again, students will ask patients about
their health and whether they want their general practitioner to call them back.
This approach has several advantages:
1. all patients will benefit from a phone call, in accordance with the recommendations of
the DGS,
2. the involvement of students, competent in medical interviews and quickly mobilizable,
will help general practitioners, on the front line of many missions, without any health
risk linked to the contagiousness of COVID-19 for students,
3. randomizing the call order will allow to assess with a high level of evidence the impact
of such an organization on hospitalizations, for two families of diseases with high
prevalence.
The trial will involve at least nine French regions. Considering that the general
practitioner's patient base numbers an average of 110 patients with chronic cardiovascular
disease or chronic mental illness, and that at least 25 general practitioners per region
participate in the study, we can expect that 22,000 patients will benefit from the
intervention of this study.
