跳至主要内容
临床试验/NCT04359875
NCT04359875已完成不适用

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

University Hospital, Tours2 个研究点 分布在 1 个国家目标入组 22,000 人开始时间: 2020年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22,000
试验地点
2
主要终点
Hospitalization(s) at 1 month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hospitalization(s) at 1 month

时间窗: 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.

次要结局

  • Cardiovascular events (MACE)(6 months)
  • Psychotropic drugs(6 months)
  • 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)
  • Number of hospitalization(s)(6 months)
  • Time to hospitalization(s)(6 months)
  • Hospitalization(s)' durations(6 months)
  • Reasons for hospitalization(s)(6 months)
  • Mortality at 6 months(6 months)
  • Phone-call from the general practitioner (in the experimental group only)(1 month)
  • Use of secondary care(6 months)
  • Psychotropic drugs(6 months)
  • Mortality at 1 month(1 month)
  • Reasons for hospitalization(s)(6 months)
  • Mortality at 6 months(6 months)
  • Use of primary care(6 months)
  • Number of hospitalization(s)(6 months)
  • Time to hospitalization(s)(6 months)
  • Number of prescriptions related to the chronic disease dispensed by the pharmacy(6 months)
  • Hospitalization(s)' durations(6 months)
  • Cardiovascular events (MACE)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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