Telemedicine Consultation in Trauma and Orthopedic

Trauma Clinical Trial

— TeleTO  

Official title:

Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815243
• Other study ID #: 1-2007-2011
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: December 26, 2008
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: Donetsk National Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Bone and Joint Abnormalities
• Joint Diseases
• Orthopedic Surgery Complications
• Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Ukraine	Central Clinical Municipal Hospital N6	Donetsk
Ukraine	Clinics of Maxillo-Fascial Surgery of DNMU	Donetsk
Ukraine	Donetsk R&D Institute of Traumatology and Orthopedics	Donetsk
Ukraine	Gorlovka Municipal Hospital N2	Gorlovka	Donetskya oblast
Ukraine	Volnovakha Central Area Hospital	Volnovakha	Donetskaya oblast

Sponsors (1)

Lead Sponsor	Collaborator
Donetsk National Medical University

Country where clinical trial is conducted

Ukraine, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scales for outcomes in trauma and orthopedic (Harris Hip Score, national protocol for trauma outcomes). Sets of criteria: ARR, RRR, AB?, RBI, RR, odds ratio and NNT		one year	Yes
Secondary	"Relevance of Telemedicine Consultation" Questionnaire		one year	Yes

External Links

•   Med-e-Tel Digital Library: 2005-2007 presentations and papers about telemedicine activity of investigators