A Phone-call With a Student/General Practitioner Team to Impact Morbidity of Chronic Patients During COVID-19 Containment
NCT ID: NCT04359875
Last Updated: 2025-12-30
Study Results
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Basic Information
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COMPLETED
NA
22000 participants
INTERVENTIONAL
2020-04-30
2020-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Management by a student/general practitioner tandem
Patients will receive a phone call from the medical student who will inquire about their health. The medical student will then transmit this information to the general practitioner who will decide on the most suitable management for the patient.
Phone-call screening and management by a medical student/general practitioner tandem
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.
Usual care
Usual care, i.e. patients will call their general practitioner when needed, up to 1 month, which corresponds to the estimated time for the intervention to be delivered to all patients in the intervention group.
At the end of the intervention at 1 month, patients in the usual care group will also receive a phone-call from the medical student/general practitioner tandem.
No interventions assigned to this group
Interventions
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Phone-call screening and management by a medical student/general practitioner tandem
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.
Eligibility Criteria
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Inclusion Criteria
* \>= 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.
* 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 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.
18 Years
110 Years
ALL
No
Sponsors
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INSERM CIC-P 1415
UNKNOWN
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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CLARISSE DIBAO-DINA, MD-PhD
Role: STUDY_DIRECTOR
University Hospital of TOURS
Locations
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Dibao-Dina
Tours, , France
Countries
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References
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Sauvage A, Laurent E, Giraudeau B, Tassi MF, Godillon L, Grammatico-Guillon L, Dibao-Dina C. Six-month outcomes after a GP phone call during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial using medico-administrative databases. BMJ Open. 2024 Nov 24;14(11):e085094. doi: 10.1136/bmjopen-2024-085094.
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.
Other Identifiers
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2020-A01061-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-CD-COVIQuest (COVID-19)
Identifier Type: -
Identifier Source: org_study_id