- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302077
Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
January 14, 2022 updated by: NYU Langone Health
This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities.
Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded.
Patients will be assigned to either group based on the last digit of their medical record number (MRN).
Patients with an even-ending medical record number will be randomized to virtual visit/telemedicine, while patients with an odd-ending medical record number will be randomized to the office visit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the differences between two forms of postoperative follow-up with respect to patient satisfaction.
The primary outcome will be patient satisfaction with their surgeon and with their overall experience.
Following their second postoperative visit, the subjects will complete one electronic survey.
The survey is designed to assess subject's overall satisfaction and satisfaction with their surgery.
This survey is standardized and will be used by both groups.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants undergoing arthroscopic hip surgery
Exclusion Criteria:
- Age < 18 years old or Age > 70 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Telemedicine Post Op
Patients with an even-ending medical record number (0,2,4,6,8) will be randomized to virtual visit/telemedicine.
This will be done by using Epic and MyChart-integrated telemedicine functionality for video visits with the Principal Investigator's patients.
This is considered standard of care.
|
interactive live-video feed at home through EPIC
|
Active Comparator: In-Office Post Op
Patients with an odd-ending medical record number (1,3,5,7,9) will be randomized to the office visit.
|
In person visit as per standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient satisfaction
Time Frame: 3 month follow up visit
|
Participant satisfaction will be measured by a electronic survey .
At the conclusion of the in-person or virtual visit, participants will be provided instructions how to access the survey questions through the QR code if in-person and through a secure link if at home via telemedicine through EPIC.
|
3 month follow up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillem Gonzalez-Lomas, NYU Langone
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
January 31, 2022
Last Update Submitted That Met QC Criteria
January 14, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-01949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data.
Upon reasonable request.
Requests should be directed to jordan.fried@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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