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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03922737
Other study ID # 2019Horneff
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 6, 2017
Est. completion date December 1, 2019

Study information

Verified date April 2019
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 198
Est. completion date December 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
In-person office visit
Post-operative visit to occur in-person with provider
Teleheath visit
Post-operative visit to occur via telehealth software platform with provider

Locations

Country Name City State
United States Rothman Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction: Likert Score Likert Score self-reported patient satisfaction 2 mont post-operative period following surgery
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