Back to resultsTelehealth Following Orthopaedic Procedures
Primary Purpose
Post-Op Complication
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-person office visit
Teleheath visit
Sponsored by
About this trial
This is an interventional treatment trial for Post-Op Complication
Eligibility Criteria
Inclusion Criteria:
1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).
Exclusion Criteria:
- Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
- Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
- Subjects with workman's compensation or automotive claims or other ongoing litigation
- Subjects that are unable or unwilling to consent for enrollment
- Patients under the age of 18 years
- Pregnant or breastfeeding women
- Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
- Patients without English-language proficiency
- Patients with unforeseen intra-operative or perioperative complications
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
In-person office visit
Telehealth visit with provider
Arm Description
Outcomes
Primary Outcome Measures
Patient Satisfaction: Likert Score
Likert Score self-reported patient satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT03922737
First Posted
April 17, 2019
Last Updated
April 19, 2019
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03922737
Brief Title
Telehealth Following Orthopaedic Procedures
Official Title
Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-person office visit
Arm Type
Active Comparator
Arm Title
Telehealth visit with provider
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
In-person office visit
Intervention Description
Post-operative visit to occur in-person with provider
Intervention Type
Procedure
Intervention Name(s)
Teleheath visit
Intervention Description
Post-operative visit to occur via telehealth software platform with provider
Primary Outcome Measure Information:
Title
Patient Satisfaction: Likert Score
Description
Likert Score self-reported patient satisfaction
Time Frame
2 mont post-operative period following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).
Exclusion Criteria:
Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
Subjects with workman's compensation or automotive claims or other ongoing litigation
Subjects that are unable or unwilling to consent for enrollment
Patients under the age of 18 years
Pregnant or breastfeeding women
Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
Patients without English-language proficiency
Patients with unforeseen intra-operative or perioperative complications
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telehealth Following Orthopaedic Procedures
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