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Patient SatisfactionNCT05998148

Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic

A study testing virtual phone appointment visits in people with Patient Satisfaction and Sports Injury, run by Jonathan Wu at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare patient reported outcomes (PROs) of patients seen at virtual phone visits compared to in-person visits for 6 weeks, 12 weeks, and 6 months post-operative follow up at a sports medicine clinic. This study will determine if there is a difference in PROs between these two groups of patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patient Satisfaction, Sports Injury, Surgery
What is being tested?
virtual phone appointment visits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 24 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are at least 18 years of age.
  • Participants who are seen at Harbor-UCLA Medical Center sports medicine clinic.
  • Participants have agreed to have operative intervention.
  • Participants must own a phone with reliable calling capabilities.
  • The Participants must have access to reliable internet to fill out the online survey.
  • The Participants must be able to provide consent.
  • Participants may include pregnant patients.

Who cannot join

  • Patients that are under the age of 18
  • any cognitive impaired adult
  • any adult unable to provide consent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

About this study

Official title: Patient Reported Outcomes From Patients Seen in Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic: A Prospective Randomized Controlled Trial

This study will compare patient reported outcomes (PROs) of patients seen at virtual phone visits compared to in-person visits for 6 weeks, 12 weeks, and 6 months post-operative follow up at a sports medicine clinic. This study will determine if there is a difference in PROs between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO compared to patients who are seen during an in-person visit for post-operative follow-up at 6-months.

Read the detailed description

In this prospective study, the investigators will enroll patients undergoing operative intervention at a Sports Medicine clinic.

The patient will arrive at a pre-operative clinic appointment, surgery, or 2 week post-operative appointment to sign the consent form in the presence of study team member and a witness in order to be eligible to participate in the study.

After consent is obtained, the Participant will be randomized to either in-person follow up or virtual phone follow up to take place after the 2-week post-op visit.

The randomization process will utilize block randomization and be conducted by an online program called http://www.randomization.com. The Participant will be assigned a number based on the order the Participant is enrolled in the study and that number will be randomly assigned to a follow-up group based on that number.

The Participant will be notified at the 2-week post-op or after if they will receive will in-person follow up or virtual phone follow-up. If the Participant in the virtual phone group feel they need an in-person visit, the Participant will be free to make an in-person follow-up. After each follow up visit (6-week, 12-week, and 6-month), the Participant will be asked to fill out 30-minute surveys.

The surveys the Participant will be asked to fill out are the following:

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS JR)- a knee specific survey
  2. Oxford Shoulder Outcome Measure
  3. Patient Reported Outcomes Measurement Information system (PROMIS) Global
  4. General Health Questionnaires (2)
  5. Patient Satisfaction Survey -The investigators will have the patient complete this also after every visit to see if their preferences change over time as their recovery changes.

If a Participant attends an in-person post-operative follow up visit, then the study team member will check to see if the participant is on the in-person list. If the participant is on the list, then he or she will be given a tablet to fill out the online survey after the appointment. The tablet will be set up so a link to the surveys can be accessed and participants can fill out the surveys. The surveys are on REDCaps (https://research.lundquist.org/redcap/surveys/?s=NK3YH4NWL3). Participants will be able to fill out the survey at home because the survey will be emailed to the participant. For Participants that attend a virtual appointment, an online link to the survey on REDCap will be sent to the Participant's email. Members of the study team can also call participant from both arms to conduct the survey over the phone.

The first page of the survey asks for the Participant's name, date of birth, and preferred language (English or Spanish), how comfortable filling out the form, who is completing the form, which joints, amount of pain, and amount of back pain. The next page of the survey will be a joint specific survey and will depend on the joint selected on the first page and the language chosen. It can be the KOOS JR, Oxford Shoulder Outcome Measure, or PROMIS Global. There is a separate patient satisfaction survey that the patient will complete.

Participants will have appointments at the sports clinic for suture removal (10 to 14 days after surgery), and evaluation at 6 weeks, 12 weeks, and 6 months after surgery per usual practice.

Study coordinator will check the upcoming Participant schedule and ensure the correct appointment is scheduled.

The source records that will be used to collect data about the Participants are the surveys, type of surgery, and results of follow-up visits. The data collected will be asked on the surveys which include demographic information- Participants' injury region, age, gender, and time since operative intervention.

A participant registry will be maintained on an excel spreadsheet to maintain participant's contact information, appointment schedule, and completion of surveys. The registry will also track which participant is in the in-person arm or virtual arm. After a new participant is consented, the information is added to the participant registry. Participant appointment dates will be kept on the registry. Each appointment scheduled in the electronic medical record will be entered in the registry and track the progress of the participant. If there is a patient that requires a change in intervention group, that is marked on the registry. For participants that do not follow up or are lost to follow up, that information is recorded.

For missing data, the information will be kept for data analysis for intention to treat analysis. The participants with missing data will be removed to conduct per protocol analysis.

Statistical analysis will be conducted to compare the total scores of each survey results from participants in the in-person group with participants in the virtual phone group. Each Participant's outcome scores will be averaged and standard deviation calculated.

Participant outcomes scores from the 6 month visit will be compared across the in-patient group and virtual phone group using Student t-test. Statistical significance will be based on an α level of 0.05.

The PROMIS Global-Physical is used to calculate the required sample size as it as the largest range of the outcome measures resulting in the most conservative estimates.

For a statistical significance of 0.05, Power of 80%, and assuming a large effect size of 0.61, 34 Participants are required per group for a total of 68 Participants.

The investigators will attempt to recruit at least 104 Participants. This will allow room in case of patients are removed or fall from the study.

Being tested
virtual phone appointment visits
Keywords
patient reported outcomes, telemedicine, virtual, phone, sports medicine, in person
Medical subject headings
Patient Satisfaction, Athletic Injuries, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual phone appointment visitsOther

    Patient will have post-operative appointments that place with telemedicine. The visits will will be virtual phone appointments scheduled at approximately 6 weeks, 12 weeks, and 6 months after surgery.

Study groups in NCT05998148
Study groupRoleWhat they receive
standard in-person appointment visitsNo interventionRandomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
virtual phone appointment visitsExperimentalRandomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
Receives: Other: virtual phone appointment visits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PROMIS Physical and Mental Scores

    Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL Survey is divided into PROMIS Physical and PROMIS Mental. Minimum score 16.2, Maximum Score 67.2 for PROMIS Physical. Minimum score 21.2, Maximum score 67.6 for PROMIS Mental. Higher score means better outcome.

    Measured: 6 month post-operative visit

Secondary outcomes (3)
  1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

    Survey scores from Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for knee injuries. Minimum score 0. Max score 100. Higher score is better.

    Measured: 6 month post-operative visit

  2. Oxford Shoulder Score

    Survey scores from the Oxford Shoulder score for shoulder injuries. Minimum is 0. Maximum is 48. Higher score is better.

    Measured: 6 month post-operative visit

  3. Patient Satisfaction Scores

    Patient satisfaction scores after in-person visit or virtual phone visit. Minium score is 1. Maximum Score 5. Higher score is better.

    Measured: 6 month post-operative visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2023
  4. Study completion24 Jan 2024

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05998148
Sponsor's protocol ID
18CR-32251-01
Status last verified
Dec 2025
First submitted
10 Aug 2023
Last updated
15 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data that results in a publication will be made available upon request.

Publications

  • Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15.

    PubMed 24342278
  • Grandizio LC, Foster BK, Klena JC. Telemedicine in Hand and Upper-Extremity Surgery. J Hand Surg Am. 2020 Mar;45(3):239-242. doi: 10.1016/j.jhsa.2019.09.007. Epub 2019 Nov 9.

    PubMed 31718846
  • Preston N, McHugh GA, Hensor EMA, Grainger AJ, O'Connor PJ, Conaghan PG, Stone MH, Kingsbury SR. Developing a standardized approach to virtual clinic follow-up of hip and knee arthroplasty. Bone Joint J. 2019 Aug;101-B(8):951-959. doi: 10.1302/0301-620X.101B8.BJJ-2018-1566.R1.

    PubMed 31362551

Questions about this trial

What is this clinical trial studying?

A study testing virtual phone appointment visits in people with Patient Satisfaction and Sports Injury, run by Jonathan Wu 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 7 inclusion and 3 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 15 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PROMIS Physical and Mental Scores (time frame: 6 month post-operative visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05998148, which also lists 3 linked publications.

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 15 Dec 2025.

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