- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03852095
Single Time Management Diseases in Pediatric Traumatology
Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study
Aperçu de l'étude
Description détaillée
The Pediatric Orthopedics and Traumatology department proposes a reform of the care in Traumatology of the children in order to improve and homogenize the care for a better relevance of these.
A recent internal study (June 2018) evaluating the relevance of the visit to traumatology consultation in our establishment to highlight that 49.3% of consultations were not relevant passages (Benign diseases of sprained ankle type, muscular contusion or simple bone removals). Indeed, these specialist consultations are currently filled by pathologies of simple treatment that do not require medical follow-up (neither clinical nor radiological follow-up).
The project consists of individualizing 5 to 6 pathologies found in consultation recurrently which the scientific literature has established that their follow-up is not justified, and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. These cards will include all the management of the pathology of the definition itself, including the treatment and expected outcomes.
The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.
The expected benefit is parental and child satisfaction, a time saving for the practitioner that he can reinvest in consultations for patients who are in fact a specialist opinion and a relative budget saving for the establishment.
The method of study of the decline of irrelevant consultations will be made by a systematic review of each reason for consultation over a period of 3 months after implementation of the cards and study of the percentage of irrelevant consultation over the same period. The objective pursued is a drop in attendance of at least 25% of consultations deemed irrelevant in Traumatology, associated with a satisfaction rate of parents greater than 90%.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Nice, France
- Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 0-18 years
- Positive diagnosis of elbow haemarthrosis, radial salter 1 fracture, fibula fracture 1 fracture, radial butter ball fracture, simple ankle sprain, simple knee sprain, fracture of the middle third of the clavicle .........
- No other associated anomaly
Exclusion Criteria:
- Refusal of the family ..............................................
- No understanding of the instructions ...............................
- Unaffiliated patient social security ..................................
- No French speaking .............
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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minor trauma
Child from 1 to 18 years old suffering an isolated minor trauma presenting at the hospital emergency services.
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following the management of the patient's fracture in the emergency department, the patients / parents are recalled 2 months (J60) after the visit to the emergency room, and are interviewed by following the pre-established interrogation form, which checks the good agreement of the patient.
treatment performed with the given sheet and recommendations, and assesses the satisfaction.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change of the number of patients routinely summoned to post-emergency trauma consultation
Délai: at 6 months
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decrease in the number of patients coming back for an unjustified consultation for these 4 pathologies by comparing the period from 6 months preceding the start of the protocol to a period of 6 months after starting the protocol.
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at 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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measurement of patient satisfaction
Délai: at 60 days after inclusion
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Call by phone the patient to measure the satisfaction by a standard questionnaire.
the scale is composed of 7 closed questions on the satisfaction of care in emergencies, the follow-up of the patient by a city doctor.
the answers are yes or no.
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at 60 days after inclusion
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compliance of care
Délai: at 60 days after inclusion
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call by phone the patient to verify the good compliance of the care.
The improvement of the care will be evaluated according to the number of patient treated for one of these pathologies having felt the need to consult another doctor / orthopedic surgeon that is envisaged by the protocol (in the days following emergency room consultation).
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at 60 days after inclusion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: RAMPAL VIRGINIE, MD, Fondation Lenval - Nice Children Hospital CHU-Lenval
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18-HPNCL-06
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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