- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03852095
Single Time Management Diseases in Pediatric Traumatology
Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study
Studieoversikt
Detaljert beskrivelse
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%.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Nice, Frankrike
- Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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 .............
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
minor trauma
Child from 1 to 18 years old suffering an isolated minor trauma presenting at the hospital emergency services.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change of the number of patients routinely summoned to post-emergency trauma consultation
Tidsramme: 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.
|
at 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
measurement of patient satisfaction
Tidsramme: at 60 days after inclusion
|
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.
|
at 60 days after inclusion
|
compliance of care
Tidsramme: at 60 days after inclusion
|
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).
|
at 60 days after inclusion
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: RAMPAL VIRGINIE, MD, Fondation Lenval - Nice Children Hospital CHU-Lenval
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18-HPNCL-06
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på minor trauma
-
National Yang Ming UniversityCheng-Hsin General HospitalFullførtSkuldersmerte | Scapular dyskinesis | SkulderpåvirkningTaiwan
-
SpirogenAvsluttetAkutt myeloid leukemi | Kronisk lymfatisk leukemiForente stater
-
Istinye UniversityFullførtStudien vil ikke være basert på noen sykdom | Evne til å svømme 100m uavhengig fristil | Være mellom 9-16 år | Fortsetter å løpe som en del av en sportsklubbTyrkia
-
Emory UniversityHar ikke rekruttert ennåRotator Cuff Tear Arthropathy | Omvendt total skulderprotese | Avansert Glenohumeral artroseForente stater
-
Riphah International UniversityRekrutteringScapular dyskinesis | Pectoralis Minor syndromPakistan
-
Affiliated Hospital of Jiaxing UniversityRekruttering
-
DERSHENG SUNUkjent
-
DuomedFullførtPerifer arteriell sykdom | Iliac arteriesykdom | Femoropoliteal okklusiv sykdom | Obstruksjon under kneetBelgia
-
Johns Hopkins UniversityWake Forest University Health Sciences; University of Washington; Louisiana... og andre samarbeidspartnereFullført
-
AllerQuest LLCFullførtHistorie om IgE-avhengig reaksjon på et penicillinproduktForente stater