Clinical trial NCT04359875: A Phone-call With a Student/General Practitioner Team to Impact Morbidity of Chronic Patients During COVID-19 Containment
Official title: Does a Systematic Phone-call by a Medical Student/General Practitioner Team in Patients Suffering From a Chronic Condition During the COVID-19 Containment Period Impact One-month Hospitalization's Rate in France? A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Mental Disorder
Keywords: general practice
COVID-19
chronic diseases
medical student
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: INSERM CIC-P 1415
First posted: 2020-04-24
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion criteria (patient with a chronic cardiovascular) :

* Male or female
* \>= 70 years of age
* Participants covered by or entitled to social security
* With a chronic cardiovascular or mental disease as referenced in the long term illness (ALD) list (i.e. with an ALD n°1, 3, 5, 12, 13 for cardiovascular disease)
* Followed regularly by their general practitioner (i.e. entered in the list of patients followed by a general practitioner by French Health Insurance
* Participants who has given oral, express and informed consent.

Inclusion criteria (patient with a mental disease) :

* Male or female
* \>= 18 years of age
* Participants covered by or entitled to social security
* With a chronic cardiovascular or mental disease as referenced in the long term illness (ALD) list (i.e. with an ALD 23 for mental disease)
* Followed regularly by their general practitioner (i.e. entered in the list of patients followed by a general practitioner by French Health Insurance
* Participants who has given oral, express and informed consent

Exclusion criteria :

* Patients with both a cardiovascular ALD and a mental health ALD (they will benefit from the intervention, without participating in the trial)
* Patients already and directly managed by their general practitioner during containment and whose general practitioner refuses that the patient be contacted by someone other than himself
* Patients unable to provide informed consent.

Primary outcomes:
measure: Hospitalization(s) at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Phone-call from the general practitioner (in the experimental group only)
timeFrame: 1 month
measure: Mortality at 1 month
timeFrame: 1 month
measure: Use of primary care
timeFrame: 6 months
measure: Use of secondary care
timeFrame: 6 months
measure: Number of prescriptions related to the chronic disease dispensed by the pharmacy
timeFrame: 6 months
measure: Number of hospitalization(s)
timeFrame: 6 months
measure: Time to hospitalization(s)
timeFrame: 6 months
measure: Hospitalization(s)' durations
timeFrame: 6 months
measure: Reasons for hospitalization(s)
timeFrame: 6 months
measure: Mortality at 6 months
timeFrame: 6 months
measure: Cardiovascular events (MACE)
timeFrame: 6 months
measure: Psychotropic drugs
timeFrame: 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Dibao-Dina
Study officials:
affiliation: University Hospital of TOURS
name: CLARISSE DIBAO-DINA, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Dibao-Dina C, Leger J, Ettori-Ajasse I, Boivin E, Chambe J, Abou-Mrad-Fricquegnon K, Sun S, Jego M, Motte B, Chiron B, Sidorkiewicz S, Khau CA, Bouchez T, Ghali M, Bruel S, Lebeau JP, Camus V, El-Hage W, Angoulvant D, Caille A, Guillon-Grammatico L, Laurent E, Saint-Lary O, Boussageon R, Pouchain D, Giraudeau B; COVIQuest group. Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial. BMJ Open. 2022 Jul 28;12(7):e059464. doi: 10.1136/bmjopen-2021-059464.