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

NCT04359875 | Completed

• 2 other identifiers: 2020-CD-COVIQuest (COVID-19)2020-A01061-38
• Study Type: interventional
• Target: 22,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Mental Disorder

Keywords

general practice; COVID-19; chronic diseases; medical student

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Phone-call from the general practitioner (in the experimental group only)

  1 month

• Mortality at 1 month

  1 month

• Use of primary care

  6 months

• Use of secondary care

  6 months

• Number of prescriptions related to the chronic disease dispensed by the pharmacy

  6 months

Study Arms (2)

Management by a student/general practitioner tandem

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Phone-call screening and management by a medical student/general practitioner tandem BEHAVIORAL

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.

Management by a student/general practitioner tandem

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead
• INSERM CIC-P 1415: collaborator

Study Sites (1)

Dibao-Dina

Tours, 37000, France

Location

Related Publications (2)

• 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.

  PMID: 39581719 RESULT

• 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.

  PMID: 35902188 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Mental Disorders; COVID-19; Chronic Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CLARISSE DIBAO-DINA, MD-PhD

  University Hospital of TOURS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: April 30, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: email

Locations

FR (1)