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History of Changes for Study: NCT03922737
Telehealth Following Orthopaedic Procedures
Latest version (submitted April 19, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 19, 2019 None (earliest Version on record)
Comparison Format:

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Study NCT03922737
Submitted Date:  April 19, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2019Horneff
Brief Title: Telehealth Following Orthopaedic Procedures
Official Title: Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: October 6, 2017
Primary Completion: June 1, 2019 [Anticipated]
Study Completion: December 1, 2019 [Anticipated]
First Submitted: April 17, 2019
First Submitted that
Met QC Criteria:
April 19, 2019
First Posted: April 22, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 19, 2019
Last Update Posted: April 22, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Post-Op Complication
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 198 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: In-person office visit Procedure: In-person office visit
Post-operative visit to occur in-person with provider
Active Comparator: Telehealth visit with provider Procedure: Teleheath visit
Post-operative visit to occur via telehealth software platform with provider
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Patient Satisfaction: Likert Score
[ Time Frame: 2 mont post-operative period following surgery ]

Likert Score self-reported patient satisfaction
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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:

  1. Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
  2. Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
  3. Subjects with workman's compensation or automotive claims or other ongoing litigation
  4. Subjects that are unable or unwilling to consent for enrollment
  5. Patients under the age of 18 years
  6. Pregnant or breastfeeding women
  7. Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
  8. Patients without English-language proficiency
  9. Patients with unforeseen intra-operative or perioperative complications
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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