Telemedicine Consultation in Trauma and Orthopedic

Overview

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.

Full Title of Study: “Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2008

Detailed Description

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.

Interventions

  • Procedure: Telemedicine consultation
    • Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
  • Procedure: Treatment plan
    • Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)

Arms, Groups and Cohorts

  • Experimental: Telemed
    • Group of trauma&orthopedic patients – for determination of clinical strategy and treatment plan telemedicine will be used
  • Active Comparator: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: one year

Secondary Measures

  • “Relevance of Telemedicine Consultation” Questionnaire
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Donetsk National Medical University
  • Provider of Information About this Clinical Study
    • Anton Vladzymyrskyy, M.D., Head of Dep. of Informaics and Telemedicine, Donetsk R&D Institute of Traumatology and Orthopedics
  • Overall Official(s)
    • Anton V Vladzymyrskyy, M.D., Principal Investigator, R&D Institute of Traumatology and Orthopedics
    • Volodymyr G Klymovytskyy, Professor, Study Director, R&D Institute of Traumatology and Orthopedics

References

Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7.

Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.

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