- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108442
Patient Satisfaction With Virtual Postoperative Visit
October 8, 2020 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.
To reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
122
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 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- > 18 years old
- < 60 years old
- Undergoing knee arthroscopy procedure
Exclusion Criteria:
- < 18 years old
- > 60 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: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Traditional
|
Surgeons (rather than individual subjects) will be randomized to traditional Postoperative follow-up modality groups.
They will adhere to this form of postoperative follow-up for all of their surgical patients (subjects) for one month.
|
|
EXPERIMENTAL: Virtual
|
Surgeons (rather than individual subjects) will be randomized to virtual postoperative follow-up modality group.
They will adhere to that form of postoperative follow-up for all of their surgical patients (subjects) for one month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction with their surgeon
Time Frame: 6 Months
|
Patients will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale, 0-"Completely Dissatisfied, 10-"Completely Satisfied"
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kirk Campbell, MD, New York Langone Health
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)
August 1, 2019
Primary Completion (ACTUAL)
March 1, 2020
Study Completion (ACTUAL)
March 1, 2020
Study Registration Dates
First Submitted
August 22, 2019
First Submitted That Met QC Criteria
September 26, 2019
First Posted (ACTUAL)
September 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 9, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-00549
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 deidentification (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.
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
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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