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
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
- 否
入选标准
- •(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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Phone-call screening and management by a medical student/general practitioner tandem (Behavioral)
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.
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)