A Phone-call With a Student/General Practitioner Team to Impact Morbidity of Chronic Patients During COVID-19 Containment (COVIQuest)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Mental Disorder
• Intervention / Treatment: Behavioral: Phone-call screening and management by a medical student/general practitioner tandem

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.

• Study Type: Interventional
• Enrollment (Actual): 22000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • Dibao-Dina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization(s) at 1 month	Hospitalization over a one month period. The primary outcome will be collected by a phone call from a medical student to the patient 1 month after randomization date. Hospitalizations (date, location, length, if available, and reason) will be collected. Because there will be many patients to be called for each practitioner, we expect these phone call to occur within a few days after day 28.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phone-call from the general practitioner (in the experimental group only)	In the experimental group only: proportion of patients for whom the practitioner had to call back after the medical student had phoned (just after allocation of the practice to the experimental group) at 1 month.	1 month
Mortality at 1 month	Mortality will be reported after checking with the city of the patient's home if there is no response to the phone call	1 month
Use of primary care	Number of general practitioner consultations and teleconsultations (and time of general practitioner consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database	6 months
Use of secondary care	Number of consultations with another medical specialist (and time of consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database	6 months
Number of prescriptions related to the chronic disease dispensed by the pharmacy	Number of prescriptions related to the chronic disease that were dispensed by the pharmacy using data from the French Health National (SNDS) Database	6 months
Number of hospitalization(s)	Number of hospitalizations using data from the French Health National (SNDS) Database	6 months
Time to hospitalization(s)	Time to hospitalization using data from the French Health National (SNDS) Database	6 months
Hospitalization(s)' durations	Hospitalization duration using data from the French Health National (SNDS) Database	6 months
Reasons for hospitalization(s)	Reason for hospitalization using data from the French Health National (SNDS) Database	6 months
Mortality at 6 months	Number of deaths using data from the French Health National (SNDS) Database	6 months
Cardiovascular events (MACE)	Only for patients in the COVIQuest_CV sub-trial: Cardiovascular events (MACE): nonfatal stroke, nonfatal myocardial infarction, cardiovascular death and hospitalization for heart failure using data from the French Health National (SNDS) Database	6 months
Psychotropic drugs	Only for patients in the COVIQuest_MH sub-trial: Psychotropic drugs consumption using data from the French Health National (SNDS) Database	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: INSERM CIC-P 1415
• Investigators: Study Director: CLARISSE DIBAO-DINA, MD-PhD, University hospital of Tours

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; general practice; chronic diseases; medical student
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Cardiovascular Diseases; Mental Disorders; Chronic Disease
• Other Study ID Numbers: 2020-CD-COVIQuest (COVID-19); 2020-A01061-38 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: One-month-data can be shared, whereas 6-month data are not legally sharable (electronic health records).
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No