Back to resultsThe Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Primary Purpose
Telemedicine, Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
About this trial
This is an interventional treatment trial for Telemedicine focused on measuring Telemedicine, Fracture, Orthopaedics
Eligibility 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
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Telemedicine
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Patient Satisfaction and Clinical Outcomes at Conclusion
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01991782
Brief Title
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Official Title
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Fracture
Keywords
Telemedicine, Fracture, Orthopaedics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.
Primary Outcome Measure Information:
Title
Patient Satisfaction and Clinical Outcomes at Conclusion
Description
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.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish K Sethi, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
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