- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00815243
Telemedicine Consultation in Trauma and Orthopedic (TeleTO)
26. december 2008 opdateret af: Donetsk National Medical University
Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic
The purpose of this study is to determine whether telemedicine consultations (lead by standard scheme)allows to increase quality of anatomical and functional outcomes and improve clinical work-flow at patients with acute bone and joint trauma, hip pathology and congenital orthopedics abnormalities.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Levels of bad outcomes, untimely death and disability due to acute trauma, specific orthopedic pathology (congenital, coxarthrosis) and non-efficient organisation of clinical work-flow are still very high (especially in rural areas).
Standard telemedicine work stations (with special protocols and manuals for original approach to telemedicine activity organisation and management) will be placed into small municipal and rural hospitals.
Telemedicine links will be established between 3rd level Trauma&Ortho center and remote sites.
Synchronous and asynchronous teleconsultations will be perform for help in evidence-based timely clinical decisions, continual support of clinical wor-flow and treatment process.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Donetsk, Ukraine, 83000
- Central Clinical Municipal Hospital N6
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Donetsk, Ukraine, 83048
- Donetsk R&D Institute of Traumatology and Orthopedics
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Donetsk, Ukraine, 83114
- Clinics of Maxillo-Fascial Surgery of DNMU
-
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Donetskaya oblast
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Volnovakha, Donetskaya oblast, Ukraine, 85700
- Volnovakha Central Area Hospital
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Donetskya oblast
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Gorlovka, Donetskya oblast, Ukraine, 84600
- Gorlovka Municipal Hospital N2
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of injury of locomotorium (isolated or polytrauma)
- Clinical diagnosis of bone and joint congenital abnormalities or intranatal injury
- Clinical diagnosis of knee, hip arthrosis
- Clinical diagnosis of complication of surgery (unstable, fracture of construction etc)
- Diagnosis is already present
- Primary decision of clinical strategy have to be done (transportation, level of care, method of treatment, surgery peculiarities)
- Indications for teleconsultations determined by physician
Exclusion Criteria:
- Diagnosis is not present
- Patient's self-request for teleconsultations
- No reliable feed-back with attending physician
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telemed
Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used
|
Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
Andre navne:
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Andre navne:
|
Aktiv komparator: InternalControl
Group of trauma&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used
|
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Andre navne:
|
Aktiv komparator: ExternalControl
Group of trauma&orthopedic patients from 1-2rd level trauma centers (in rural and small municipal hospitals) - for determination of clinical strategy and treatment plan personal arriving of the expert by the car (so-called Urgent Expert Care) will be used
|
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Scales for outcomes in trauma and orthopedic (Harris Hip Score, national protocol for trauma outcomes). Sets of criteria: ARR, RRR, ABІ, RBI, RR, odds ratio and NNT
Tidsramme: one year
|
one year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
"Relevance of Telemedicine Consultation" Questionnaire
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Anton V Vladzymyrskyy, M.D., R&D Institute of Traumatology and Orthopedics
- Studieleder: Volodymyr G Klymovytskyy, Professor, R&D Institute of Traumatology and Orthopedics
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2007
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
26. december 2008
Først indsendt, der opfyldte QC-kriterier
26. december 2008
Først opslået (Skøn)
29. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. december 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. december 2008
Sidst verificeret
1. december 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1-2007-2011
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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