Optimisation du Parcours de Soins Des Enfants fébriles Par l'Utilisation de la CRP Capillaire en Soins Primaires : Protocole d'un Essai Multicentrique randomisé
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 37
- 主要终点
- Referral rates to any facility equipped for emergency laboratory testing between conditions
研究概览
简要总结
Fever is the leading reason for outpatient consultations among children aged 2 to 9 years. The main concern in fever is severe bacterial infection, particularly for younger children. History and clinical examination do not always differentiate viral infections from bacterial infection. In 20% of febrile children, no infectious focus is found after examination and additional tests are necessary. The first one is measuring C-reactive protein (CRP). The results are obtained in several hours on an outpatient basis, causing long delays before starting treatment and often requiring telephone calls or further consultations. Emergency room use is constantly increasing, generating growing tensions within healthcare facilities, yet a large number of visits are avoidable. Among children visiting the pediatric emergency room, parents reported being referred by their primary care physician in approximately 20% of cases for children aged 1 to 5 years and in 30% of cases for children under one year old. The use of capillary medical device to measure CRP in primary care could reduce this referral rate and help relieve overcrowding in emergency rooms, as well as unscheduled consultation centers and medical analysis laboratories. This would result in a streamlined care pathway, saving time for both physicians and patients, as well as reducing the cost of care for the healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be a member or beneficiary of a health insurance plan
- •Children consulting primary health institutes with fever (temperature ≥ 38°C) requiring CRP testing:
- •Fever > 12h in infants aged 3 to 6 months
- •Fever ≥ 5 days in children over 6 months of age
- •Fever >12h regardless of age, and at the time of consultation, the doctor is concerned about the child's general condition, the tolerance of the fever, or doubts about a bacterial focus (e.g. suspicion of pneumopathy, appendicitis, etc.).
- •No severity criteria necessitating immediate hospitalization
- •No bacterial infection whose diagnosis is exclusively clinical or identified by other means (e.g. purulent AOM, bacterial angina identified by RDT, etc.).
- •Child whose parents and child have been informed about the study, and at least one parent has given consent for their child's participation in the study.
- •Enrolment of the child according to their capacity of discernment (for children aged 12 and over, enrolment is essential).
- •Child affiliated to or benefiting from a health insurance scheme
排除标准
- •The subject is participating in a category 1 interventional study, or a study with drug or medical device
- •Premature infants under one year of age
- •Immunosuppression
- •Sunstroke
- •Chronic infection
- •Malignant pathology
- •Autoimmune pathology
- •Sickle cell disease
- •Child with a central catheter
研究组 & 干预措施
Capillary CRP
干预措施: Capillary CRP (Other)
Control
Prior to Capillary CRP condition
结局指标
主要结局
Referral rates to any facility equipped for emergency laboratory testing between conditions
时间窗: Day 7
Referral: Yes/No as reported by the parents
Referral rates to any facility equipped for emergency laboratory testing between conditions
时间窗: Day 1
Referral: Yes/No as reported by the physician
次要结局
- The total duration of GP time between conditions(Day 7)
- Referral rates to medical biology laboratories between conditions(Day 7)
- Parent satisfaction with the care pathway(Day 7)
- Rate of antibiotic prescription between conditions(Day 7)
- Duration of fever episode between groups(Day 7)
- Referral rates to emergency departments between conditions(Day 7)
- Number complementary tests between conditions(Day 7)
- Type of complementary tests between conditions(Day 7)
- GP satisfaction on care organization(Day 7)
- Cost-consequences between groups(Day 7)
- Budget impact analysis(Day 7)
- Referral rates to medical biology laboratories between conditions(Day 1)
- Referral rates to emergency departments between conditions(Day 1)
- Number complementary tests between conditions(Day 1)
- Type of complementary tests between conditions(Day 1)
- Rate of antibiotic prescription between conditions(Day 1)