Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care

Centre Hospitalier Universitaire de Nīmes420 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

420

Conditions

Fever

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (16)

MSP OLEA

Bezouce, France

RECRUITING

MSP Espace Santé Servian

Béziers, France

RECRUITING

MSPU Avicenne

Cabestany, France

RECRUITING

MSP de Calvisson

Calvisson, France

RECRUITING

MSP de Clarensac

Caveirac, France

RECRUITING

MMG de Montpellier

Montpellier, France

RECRUITING

MSP Montpellier-Cévennes

Montpellier, France

RECRUITING

MMG de Narbonne

Narbonne, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

MMG de Nîmes

Nîmes, France

RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

Referral rates to any facility equipped for emergency laboratory testing between conditions

Referral: Yes/No as reported by the physician

Time frame: Day 1

Referral rates to any facility equipped for emergency laboratory testing between conditions

Referral: Yes/No as reported by the parents

Time frame: Day 7

Secondary Outcomes

Referral rates to medical biology laboratories between conditions

Referral: Yes/No as reported by the physician

Time frame: Day 1

Referral rates to medical biology laboratories between conditions

Referral: Yes/No as reported by the parents

Time frame: Day 7

Referral rates to emergency departments between conditions

Referral: Yes/No as reported by the physician

Time frame: Day 1

Referral rates to emergency departments between conditions

Referral: Yes/No as reported by the parents

Time frame: Day 7

Number complementary tests between conditions

Total number of tests as reported by the physician

Time frame: Day 1

Number complementary tests between conditions

Total number of tests as reported by the parents

Time frame: Day 7

Type of complementary tests between conditions

Qualitative listing of all further tests classified as: biological (CBC, venous CRP, iono/creatininemia, liver function tests, ECBU, others) or imaging (chest X-ray, abdomino-pelvic ultrasound, urinary and renal ultrasound) as reported by the physician

Time frame: Day 1

Type of complementary tests between conditions

Time frame: Day 7

GP satisfaction on care organization

0-10 visual analog scale

Time frame: Day 7

The total duration of GP time between conditions

Minutes: measured as consultation time + examination time and time to inform the family

Time frame: Day 7

Parent satisfaction with the care pathway

0-10 numeric scale

Time frame: Day 7

Rate of antibiotic prescription between conditions

Antibiotic prescription: Yes/No as reported by the physician

Time frame: Day 1

Rate of antibiotic prescription between conditions

Antibiotic prescription: Yes/No as reported by the parents

Time frame: Day 7

Duration of fever episode between groups

Days counted upon reaching 24 hours without fever

Time frame: Day 7

Cost-consequences between groups

euros

Time frame: Day 7

Budget impact analysis

euros

Time frame: Day 7

Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care

Overview

Conditions

Interventions

Eligibility

Locations (16)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts