Post-Op ComplicationNCT04108442
Patient Satisfaction With Virtual Postoperative Visit
A study testing Traditional and Virtual in people with Post-Op Complication, 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 60 years
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- Traditional and Virtual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Mar 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- > 18 years old
- < 60 years old
- Undergoing knee arthroscopy procedure
Who cannot join
- < 18 years old
- > 60 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. 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).
- Conditions
- Post-Op Complication
- Being tested
- Traditional, Virtual
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraditionalBehavioural
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.
VirtualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Not described Receives: Behavioral: Traditional |
| Virtual | Experimental | Not described Receives: Behavioral: Virtual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with their surgeon
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"
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirk Campbell, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108442
- Sponsor's protocol ID
- 19-00549
- Status last verified
- Oct 2020
- First submitted
- 22 Aug 2019
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Virtual Postoperative Visit
- ClinicalTrials.gov ID
- NCT04108442
- Acronym / sponsor ID
- 19-00549
- Conditions
- Post-Op Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Sep 2019 (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. 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Behavioral: Traditional |
| Virtual | Experimental | Behavioral: Virtual |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- > 18 years old
- < 60 years old
- Undergoing knee arthroscopy procedure
Key exclusion criteria (2 listed)
- < 18 years old
- > 60 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 |
|---|---|---|
| TraditionalSurgeons (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. | Behavioural | Traditional |
| VirtualSurgeons (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. | Behavioural | Virtual |
Primary outcome
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"
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 9 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (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.
Kirk Campbell, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional and Virtual in people with Post-Op Complication, 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 3 inclusion and 2 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 9 Oct 2020. 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?
Patient Satisfaction with their surgeon (time frame: 6 Months). 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 9 Oct 2020.