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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Orthopedic Disorder; Patient Satisfaction; Sports Injury
• Intervention / Treatment: Other: virtual phone appointment visits

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard in-person appointment visits; Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
Experimental: virtual phone appointment visits; Randomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.	Other: virtual phone appointment visits; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month post-operative visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 month post-operative visit

Collaborators and Investigators

• Sponsor: Jonathan Wu
• Investigators: Principal Investigator: John P Andrawis, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: telemedicine; virtual; sports medicine; patient reported outcomes; phone; in person
• Additional Relevant MeSH Terms: Wounds and Injuries; Behavior; Treatment Adherence and Compliance; Health Behavior; Musculoskeletal Diseases; Athletic Injuries; Patient Satisfaction
• Other Study ID Numbers: 18CR-32251-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data that results in a publication will be made available upon request.
• IPD Sharing Time Frame: information will be made available starting after publication. The information will be available for 3 years after publication.
• IPD Sharing Access Criteria: Criteria include other researchers interested in patient reported outcomes, for analyses related to telemedicine. Study coordinator will review requests for more data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No