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.
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
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:
- Knee Injury and Osteoarthritis Outcome Score (KOOS JR)- a knee specific survey
- Oxford Shoulder Outcome Measure
- Patient Reported Outcomes Measurement Information system (PROMIS) Global
- General Health Questionnaires (2)
- 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.
- Conditions
- Patient Satisfaction, Sports Injury, Surgery, Orthopedic Disorder
- 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 group | Role | What they receive |
|---|---|---|
| standard in-person appointment visits | No intervention | Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery. |
| virtual phone appointment visits | Experimental | Randomly 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.
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)
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
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
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.
- First posted18 Aug 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Wu, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- John P Andrawis, M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24342278Grandizio 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 31718846Preston 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05998148
- Acronym / sponsor ID
- 18CR-32251-01
- Conditions
- Patient Satisfaction, Sports Injury, Surgery, Orthopedic Disorder
- Keywords
- patient reported outcomes, telemedicine, virtual, phone, sports medicine, in person
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jonathan WuUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Knee Injury and Osteoarthritis Outcome Score (KOOS JR)- a knee specific survey
- Oxford Shoulder Outcome Measure
- Patient Reported Outcomes Measurement Information system (PROMIS) Global
- General Health Questionnaires (2)
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard in-person appointment visits | No intervention | –Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery. |
| virtual phone appointment visits | Experimental | Other: virtual phone appointment visitsRandomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients that are under the age of 18
- any cognitive impaired adult
- any adult unable to provide consent.
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 phone appointment visitsPatient 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. | Other | virtual phone appointment visits |
Primary outcome
PROMIS Physical and Mental Scores
Time frame: 6 month post-operative visit
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.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Time frame: 6 month post-operative visit
Oxford Shoulder Score
Time frame: 6 month post-operative visit
Patient Satisfaction Scores
Time frame: 6 month post-operative visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24342278Sharareh 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.
- Background: PubMed 31718846Grandizio 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.
- Background: PubMed 31362551Preston 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.
- Individual participant dataSharing planned: Yes. The individual participant data that results in a publication will be made available upon request.
Related trials for Patient Satisfaction
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
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.
John P Andrawis, M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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 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.