- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03852095
Single Time Management Diseases in Pediatric Traumatology
Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study
Panoramica dello studio
Descrizione dettagliata
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%.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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-
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Nice, Francia
- Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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 .............
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change of the number of patients routinely summoned to post-emergency trauma consultation
Lasso di tempo: at 6 months
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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measurement of patient satisfaction
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: RAMPAL VIRGINIE, MD, Fondation Lenval - Nice Children Hospital CHU-Lenval
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 18-HPNCL-06
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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