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The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures

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ClinicalTrials.gov Identifier: NCT01991782
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Manish Sethi, Vanderbilt University

Study Description
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Brief Summary:
The purpose of this study is to determine whether telemedicine video calls for follow-up visits between patients and their orthopaedic trauma surgeons has an impact on patient satisfaction, quality of life, and treatment adherence. This study will also assess the feasibility of telemedicine as a medium for follow-up visits.

Condition or disease Intervention/treatment Phase
Telemedicine Fracture Other: Telemedicine Not Applicable

Detailed Description:
Patients who are over the age of 18 years with closed fractures treated at Vanderbilt University Medical Center by the Orthopaedic Trauma Department will be recruited into the study into one of two arms: a telemedicine arm in which the patient will have some of his or her visits conducted through video calls, and a control arm in which all of the visits for the patient will be in-person at the Vanderbilt University Orthopaedic Trauma Clinic. Comparisons between the two groups will be made through surveys administered to the patients half-way through the study and at the conclusion of the study, and comparisons will be made using standard statistical tests. The feasibility of telemedicine as a medium for follow-up visits in lieu of in-person visits will be assessed in this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Control patients with all follow-up visits in person at the Vanderbilt Orthopaedic Trauma clinic (2 weeks, 6 weeks, 3 months, and 6 months post-operative).
Experimental: Telemedicine
Experimental cohort with two follow-up visits (6 weeks and 6 months) occurring via telemedicine video calls and two follow-up visits (2 weeks and 3 months) occurring in person.
 Other: Telemedicine
Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Satisfaction and Clinical Outcomes at Conclusion [ Time Frame: 6 month ]
    Surveys will be administered to all patients in both arms of the study at the conclusion of the study to assess patient satisfaction with their treatment arms. Furthermore, all clinical outcomes for patients with be addressed at this point to note fracture healing status, any development of complications, and any redefinition of goals of care.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home

Exclusion Criteria:

  • patients as part of vulnerable populations
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991782


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Manish K Sethi, MD Vanderbilt University
More Information
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Responsible Party: Manish Sethi, Assistant Professor of Orthopaedics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01991782    
Other Study ID Numbers: 120725
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Manish Sethi, Vanderbilt University:
Telemedicine
Fracture
Orthopaedics
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries