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

Primary Purpose

Patient Satisfaction, Sports Injury, Surgery

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual phone appointment visits
Sponsored by
Jonathan Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Satisfaction focused on measuring patient reported outcomes, telemedicine, virtual, phone, sports medicine, in person

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard in-person appointment visits

virtual phone appointment visits

Arm Description

Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.

Randomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System Global survey scores
Participant reported outcome scores through PROMIS Global. Minimum score 16.2. Maximum Score 67.2 Higher score mean better outcome.

Secondary Outcome Measures

Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Survey scores from KOOS JR for knee injuries. Minimum score 0. Max score 100. Higher score is better.
Quick Disabilities of the Arm, Shoulder, and Hand survey scores
survey scores from QuickDASH for shoulder injuries. Minimum is 0. Maximum is 100. Lower score is better.
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.

Full Information

First Posted
August 10, 2023
Last Updated
August 16, 2023
Sponsor
Jonathan Wu
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1. Study Identification

Unique Protocol Identification Number
NCT05998148
Brief Title
Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare patient reported outcomes (PROs) and patient satisfaction scores of patients seen at virtual phone visits with patients seen at in-person visits for post-operative follow up at 6 weeks, 12 weeks, and 6 months at a sports medicine clinic. This study will determine if there is a difference in PROs and satisfaction scores between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO and patient satisfaction scores compared to patients who are seen during an in-person visit for post-operative follow-up at 6 weeks, 12 weeks, and 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 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)- a knee specific survey Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH) 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, QuickDASH 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, and 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 outcomes scores will be averaged with standard deviation calculated. Participant outcomes scores from each appointment time frame (6-week, 12 week, and 6 months) 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. To determine if there is a difference among the Participants' preference for an in-person visit or telemedicine visit, the investigators will conduct a chi-squared test comparing the percentage of Participant responses from the in-patient group with responses from virtual phone group. Within each category, to determine if Participant's satisfaction changed as time progressed, the investigators will conduct an Analysis of Variance. This will help us determine if Participants who experience virtual phone visits start to have changing satisfaction the longer time has elapsed since initial operative intervention. The PROMIS Global 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 0.8, 26 Participants are required per group for a total of 52 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction, Sports Injury, Surgery, Orthopedic Disorder
Keywords
patient reported outcomes, telemedicine, virtual, phone, sports medicine, in person

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard in-person appointment visits
Arm Type
No Intervention
Arm Description
Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
Arm Title
virtual phone appointment visits
Arm Type
Experimental
Arm Description
Randomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
Intervention Type
Other
Intervention Name(s)
virtual phone appointment visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System Global survey scores
Description
Participant reported outcome scores through PROMIS Global. Minimum score 16.2. Maximum Score 67.2 Higher score mean better outcome.
Time Frame
after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
Secondary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Description
Survey scores from KOOS JR for knee injuries. Minimum score 0. Max score 100. Higher score is better.
Time Frame
after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
Title
Quick Disabilities of the Arm, Shoulder, and Hand survey scores
Description
survey scores from QuickDASH for shoulder injuries. Minimum is 0. Maximum is 100. Lower score is better.
Time Frame
after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
Title
Patient satisfaction scores
Description
Patient satisfaction scores after in-person visit or virtual phone visit. Minium score is 1. Maximum Score 5. Higher score is better.
Time Frame
after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Andrawis, M.D.
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24342278
Citation
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.
Results Reference
background
PubMed Identifier
31718846
Citation
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.
Results Reference
background
PubMed Identifier
31362551
Citation
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.
Results Reference
background

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

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