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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359875
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
INSERM CIC-P 1415
Information provided by (Responsible Party):
University Hospital, Tours

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Mental Disorder Behavioral: Phone-call screening and management by a medical student/general practitioner tandem Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22000 participants
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
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
Actual Study Start Date : April 30, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : December 31, 2020


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.




Primary Outcome Measures :
  1. Hospitalization(s) at 1 month [ Time Frame: 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.


Secondary Outcome Measures :
  1. Phone-call from the general practitioner (in the experimental group only) [ Time Frame: 1 month ]
    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.

  2. Mortality at 1 month [ Time Frame: 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

  3. Use of primary care [ Time Frame: 6 months ]
    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

  4. Use of secondary care [ Time Frame: 6 months ]
    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

  5. Number of prescriptions related to the chronic disease dispensed by the pharmacy [ Time Frame: 6 months ]
    Number of prescriptions related to the chronic disease that were dispensed by the pharmacy using data from the French Health National (SNDS) Database

  6. Number of hospitalization(s) [ Time Frame: 6 months ]
    Number of hospitalizations using data from the French Health National (SNDS) Database

  7. Time to hospitalization(s) [ Time Frame: 6 months ]
    Time to hospitalization using data from the French Health National (SNDS) Database

  8. Hospitalization(s)' durations [ Time Frame: 6 months ]
    Hospitalization duration using data from the French Health National (SNDS) Database

  9. Reasons for hospitalization(s) [ Time Frame: 6 months ]
    Reason for hospitalization using data from the French Health National (SNDS) Database

  10. Mortality at 6 months [ Time Frame: 6 months ]
    Number of deaths using data from the French Health National (SNDS) Database

  11. Cardiovascular events (MACE) [ Time Frame: 6 months ]
    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

  12. Psychotropic drugs [ Time Frame: 6 months ]
    Only for patients in the COVIQuest_MH sub-trial: Psychotropic drugs consumption using data from the French Health National (SNDS) Database



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359875


Locations
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France
Dibao-Dina
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
INSERM CIC-P 1415
Investigators
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Study Director: CLARISSE DIBAO-DINA, MD-PhD University Hospital of TOURS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT04359875    
Other Study ID Numbers: 2020-CD-COVIQuest (COVID-19)
2020-A01061-38 ( Registry Identifier: ID-RCB )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: One-month-data can be shared, whereas 6-month data are not legally sharable (electronic health records).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year
Access Criteria: email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
general practice
COVID-19
chronic diseases
medical student
Additional relevant MeSH terms:
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COVID-19
Cardiovascular Diseases
Mental Disorders
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases