Femoroacetabular ImpingementNCT04302077
Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
A study testing virtual doctor visit in people with Femoroacetabular Impingement, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- virtual doctor visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants undergoing arthroscopic hip surgery
Who cannot join
- Age < 18 years old or Age > 70 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- virtual doctor visit, Standard care doctor's visit
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual doctor visitOther
interactive live-video feed at home through EPIC
Standard care doctor's visitOther
In person visit as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Post Op | Active comparator | 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. Receives: Other: virtual doctor visit |
| In-Office Post Op | Active comparator | Patients with an odd-ending medical record number (1,3,5,7,9) will be randomized to the office visit. Receives: Other: Standard care doctor's visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient satisfaction
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.
Measured: 3 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Mar 2020
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzalez-Lomas, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302077
- Sponsor's protocol ID
- 19-01949
- Status last verified
- Jan 2022
- First submitted
- 6 Mar 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT04302077
- Acronym / sponsor ID
- 19-01949
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Post Op | Active comparator | Other: virtual doctor visitPatients 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. |
| In-Office Post Op | Active comparator | Other: Standard care doctor's visitPatients with an odd-ending medical record number (1,3,5,7,9) will be randomized to the office visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants undergoing arthroscopic hip surgery
Key exclusion criteria (1 listed)
- Age < 18 years old or Age > 70 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual doctor visitinteractive live-video feed at home through EPIC | Other | Telemedicine Post Op |
| Standard care doctor's visitIn person visit as per standard of care | Other | In-Office Post Op |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Gonzalez-Lomas principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual doctor visit in people with Femoroacetabular Impingement, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient satisfaction (time frame: 3 month follow up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.