A Phone-call With a Student/General Practitioner Team to Impact Morbidity of Chronic Patients During COVID-19 Containment
Condition: Cardiovascular Diseases; Mental Disorder
MeSH terms: COVID-19; Cardiovascular Diseases; Mental Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Phone-call screening and management by a medical student/general practitioner tandem
Intervention type(s): Behavioral
Intervention description(s): Systematic phone contact of the patient by a medical student, under the indirect supervision of the general practitioner. This phone contact will be standardized with 3 questions to ask to the patient:
How are you doing? (with a Likert scale from 1=very bad to 10=very well)
Would you have made an appointment with your general practitioner if there had not been COVID19 epidemic and containment?
Would you like an appointment with your doctor and / or has your doctor ever contacted you? In view of the answers to these 3 questions, the general practitioner will decide whether it is necessary to propose a consultation or a teleconsultation to the patient, taking into account his/her medical background.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized trial with 2 subtrials : COVIQuest_CV and COVIQuest_MH.
COVIQuest_CV involves patients ≥ 70 years old suffering from chronic cardiovascular disease; and COVIQuest_MH involves patients suffering from a mental health disease.
As a note, both sub-trials are two-parallel group cluster randomized trials. Clusters will be defined as practices. Practices will be randomized into two groups A and B. For practices in group A: their CV patients constitute the experimental group for the COVIQuest_CV trial, their MH patients constitute the control group for the COVIQuest_MH trial. For practices in group B: their CV patients constitute the control group for the COVIQuest_CV trial, their MH patients constitute the experimental group for the COVIQuest_MH trial.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: general practice; COVID-19; chronic diseases; medical student