xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998148</url>
    </required_header>
    <id_info>
      <org_study_id>18CR-32251-01</org_study_id>
      <nct_id>NCT05998148</nct_id>
    </id_info>
    <brief_title>Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jonathan Wu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will compare patient reported outcomes (PROs) and patient satisfaction scores of&#xD;
        patients seen at virtual phone visits with patients seen at in-person visits for&#xD;
        post-operative follow up at 6 weeks, 12 weeks, and 6 months at a sports medicine clinic. This&#xD;
        study will determine if there is a difference in PROs and satisfaction scores between these&#xD;
        two groups of patients. The investigators hypothesize patients who are seen during a virtual&#xD;
        phone visit will report different PRO and patient satisfaction scores compared to patients&#xD;
        who are seen during an in-person visit for post-operative follow-up at 6 weeks, 12 weeks, and&#xD;
        6-months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this prospective study, the investigators will enroll patients undergoing operative&#xD;
        intervention at a Sports Medicine clinic.&#xD;
  &#xD;
        The patient will arrive at a pre-operative clinic appointment, surgery, or 2 week&#xD;
        post-operative appointment to sign the consent form in the presence of study team member and&#xD;
        a witness in order to be eligible to participate in the study.&#xD;
  &#xD;
        After consent is obtained, the Participant will be randomized to either in-person follow up&#xD;
        or virtual phone follow up to take place after the 2-week post-op visit.&#xD;
  &#xD;
        The randomization process will utilize block randomization and be conducted by an online&#xD;
        program called http://www.randomization.com. The Participant will be assigned a number based&#xD;
        on the order the Participant is enrolled in the study and that number will be randomly&#xD;
        assigned to a follow-up group based on that number.&#xD;
  &#xD;
        The Participant will be notified at the 2-week post-op or after if they will receive&#xD;
        in-person follow up or virtual phone follow-up. If the Participant in the virtual phone group&#xD;
        feel they need an in-person visit, the Participant will be free to make an in-person&#xD;
        follow-up. After each follow up visit (6-week, 12-week, and 6-month), the Participant will be&#xD;
        asked to fill out 30-minute surveys.&#xD;
  &#xD;
        The surveys the Participant will be asked to fill out are the following:&#xD;
  &#xD;
          1. Knee Injury and Osteoarthritis Outcome Score (KOOS)- a knee specific survey&#xD;
  &#xD;
          2. Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH) Outcome Measure&#xD;
  &#xD;
          3. Patient Reported Outcomes Measurement Information system (PROMIS) Global&#xD;
  &#xD;
          4. General Health Questionnaires (2)&#xD;
  &#xD;
          5. Patient Satisfaction Survey -The investigators will have the patient complete this also&#xD;
             after every visit to see if their preferences change over time as their recovery&#xD;
             changes.&#xD;
  &#xD;
        If a Participant attends an in-person post-operative follow up visit, then the study team&#xD;
        member will check to see if the participant is on the in-person list. If the participant is&#xD;
        on the list, then he or she will be given a tablet to fill out the online survey after the&#xD;
        appointment. The tablet will be set up so a link to the surveys can be accessed and&#xD;
        participants can fill out the surveys. The surveys are on REDCaps&#xD;
        (https://research.lundquist.org/redcap/surveys/?s=NK3YH4NWL3). Participants will be able to&#xD;
        fill out the survey at home because the survey will be emailed to the participant. For&#xD;
        Participants that attend a virtual appointment, an online link to the survey on REDCap will&#xD;
        be sent to the Participant's email. Members of the study team can also call participant from&#xD;
        both arms to conduct the survey over the phone.&#xD;
  &#xD;
        The first page of the survey asks for the Participant's name, date of birth, and preferred&#xD;
        language (English or Spanish), how comfortable filling out the form, who is completing the&#xD;
        form, which joints, amount of pain, and amount of back pain. The next page of the survey will&#xD;
        be a joint specific survey and will depend on the joint selected on the first page and the&#xD;
        language chosen. It can be the KOOS, QuickDASH Outcome Measure, or PROMIS Global. There is a&#xD;
        separate patient satisfaction survey that the patient will complete.&#xD;
  &#xD;
        Participants will have appointments at the sports clinic for suture removal (10 to 14 days&#xD;
        after surgery), and evaluation at 6 weeks, 12 weeks, and 6 months after surgery per usual&#xD;
        practice.&#xD;
  &#xD;
        Study coordinator will check the upcoming Participant schedule and ensure the correct&#xD;
        appointment is scheduled.&#xD;
  &#xD;
        The source records that will be used to collect data about the Participants are the surveys,&#xD;
        and type of surgery, and results of follow up visits. The data collected will be asked on the&#xD;
        surveys which include demographic information- Participants' injury region, age, gender, and&#xD;
        time since operative intervention.&#xD;
  &#xD;
        A participant registry will be maintained on an excel spreadsheet to maintain participant's&#xD;
        contact information, appointment schedule, and completion of surveys. The registry will also&#xD;
        track which participant is in the in-person arm or virtual arm. After a new participant is&#xD;
        consented, the information is added to the participant registry. Participant appointment&#xD;
        dates will be kept on the registry. Each appointment scheduled in the electronic medical&#xD;
        record will be entered in the registry and track the progress of the participant. If there is&#xD;
        a patient that requires a change in intervention group, that is marked on the registry. For&#xD;
        participants that do not follow up or are lost to follow up, that information is recorded.&#xD;
  &#xD;
        For missing data, the information will be kept for data analysis for intention to treat&#xD;
        analysis. The participants with missing data will be removed to conduct per protocol&#xD;
        analysis.&#xD;
  &#xD;
        Statistical analysis will be conducted to compare the total scores of each survey results&#xD;
        from participants in the in-person group with participants in the virtual phone group. Each&#xD;
        Participant outcomes scores will be averaged with standard deviation calculated.&#xD;
  &#xD;
        Participant outcomes scores from each appointment time frame (6-week, 12 week, and 6 months)&#xD;
        will be compared across the in-patient group and virtual phone group using Student t-test.&#xD;
        Statistical significance will be based on an α level of 0.05.&#xD;
  &#xD;
        To determine if there is a difference among the Participants' preference for an in-person&#xD;
        visit or telemedicine visit, the investigators will conduct a chi-squared test comparing the&#xD;
        percentage of Participant responses from the in-patient group with responses from virtual&#xD;
        phone group.&#xD;
  &#xD;
        Within each category, to determine if Participant's satisfaction changed as time progressed,&#xD;
        the investigators will conduct an Analysis of Variance. This will help us determine if&#xD;
        Participants who experience virtual phone visits start to have changing satisfaction the&#xD;
        longer time has elapsed since initial operative intervention.&#xD;
  &#xD;
        The PROMIS Global is used to calculate the required sample size as it as the largest range of&#xD;
        the outcome measures resulting in the most conservative estimates.&#xD;
  &#xD;
        For a statistical significance of 0.05, Power of 80%, and assuming a large effect size of&#xD;
        0.8, 26 Participants are required per group for a total of 52 Participants.&#xD;
  &#xD;
        The investigators will attempt to recruit at least 104 Participants. This will allow room in&#xD;
        case of patients are removed or fall from the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System Global survey scores</measure>
      <time_frame>after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit</time_frame>
      <description>Participant reported outcome scores through PROMIS Global. Minimum score 16.2. Maximum Score 67.2 Higher score mean better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knee injury and Osteoarthritis Outcome Score for Joint Replacement</measure>
      <time_frame>after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit</time_frame>
      <description>Survey scores from KOOS JR for knee injuries. Minimum score 0. Max score 100. Higher score is better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quick Disabilities of the Arm, Shoulder, and Hand survey scores</measure>
      <time_frame>after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit</time_frame>
      <description>survey scores from QuickDASH for shoulder injuries. Minimum is 0. Maximum is 100. Lower score is better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction scores</measure>
      <time_frame>after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit</time_frame>
      <description>Patient satisfaction scores after in-person visit or virtual phone visit. Minium score is 1. Maximum Score 5. Higher score is better.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">90</enrollment>
    <condition>Patient Satisfaction</condition>
    <condition>Sports Injury</condition>
    <condition>Surgery</condition>
    <condition>Orthopedic Disorder</condition>
    <arm_group>
      <arm_group_label>standard in-person appointment visits</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>virtual phone appointment visits</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>virtual phone appointment visits</intervention_name>
      <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.</description>
      <arm_group_label>virtual phone appointment visits</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants are at least 18 years of age.&#xD;
  &#xD;
            -  Participants who are seen at Harbor-UCLA Medical Center sports medicine clinic.&#xD;
  &#xD;
            -  Participants have agreed to have operative intervention.&#xD;
  &#xD;
            -  Participants must own a phone with reliable calling capabilities.&#xD;
  &#xD;
            -  The Participants must have access to reliable internet to fill out the online survey.&#xD;
  &#xD;
            -  The Participants must be able to provide consent.&#xD;
  &#xD;
            -  Participants may include pregnant patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients that are under the age of 18&#xD;
  &#xD;
            -  any cognitive impaired adult&#xD;
  &#xD;
            -  any adult unable to provide consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John P Andrawis, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Harbor-UCLA Medical Center</name>
        <address>
          <city>Torrance</city>
          <state>California</state>
          <zip>90502</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>24342278</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31718846</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31362551</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</investigator_affiliation>
      <investigator_full_name>Jonathan Wu</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <keyword>patient reported outcomes</keyword>
    <keyword>telemedicine</keyword>
    <keyword>virtual</keyword>
    <keyword>phone</keyword>
    <keyword>sports medicine</keyword>
    <keyword>in person</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Diseases</mesh_term>
      <mesh_term>Athletic Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The individual participant data that results in a publication will be made available upon request.</ipd_description>
      <ipd_time_frame>information will be made available starting after publication. The information will be available for 3 years after publication.</ipd_time_frame>
      <ipd_access_criteria>Criteria include other researchers interested in patient reported outcomes, for analyses related to telemedicine. Study coordinator will review requests for more data.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>November 9, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT05998148/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998148
  org study id: 18CR-32251-01
  nct id: NCT05998148
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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:
  
          1. Knee Injury and Osteoarthritis Outcome Score (KOOS)- a knee specific survey
  
          2. Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH) 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, 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Patient-Reported Outcomes Measurement Information System Global survey scores
  time frame: after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
  description: Participant reported outcome scores through PROMIS Global. Minimum score 16.2. Maximum Score 67.2 Higher score mean better outcome.
  measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement
  time frame: after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
  description: Survey scores from KOOS JR for knee injuries. Minimum score 0. Max score 100. Higher score is better.
  measure: Quick Disabilities of the Arm, Shoulder, and Hand survey scores
  time frame: after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
  description: survey scores from QuickDASH for shoulder injuries. Minimum is 0. Maximum is 100. Lower score is better.
  measure: Patient satisfaction scores
  time frame: after 6 week post-operative visit, 12 week post-operative visit, and 6 month post-operative visit
  description: Patient satisfaction scores after in-person visit or virtual phone visit. Minium score is 1. Maximum Score 5. Higher score is better.
  arm group label: standard in-person appointment visits
  arm group type: No Intervention
  description: Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.
  arm group label: virtual phone appointment visits
  arm group type: Experimental
  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: virtual phone appointment visits
  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.
  arm group label: virtual phone appointment visits
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John P Andrawis, M.D.
  role: Principal Investigator
  affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  facility: 
  country: United States
  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.
  PMID: 24342278
  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.
  PMID: 31718846
  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.
  PMID: 31362551
  responsible party type: Sponsor-Investigator
  investigator affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  investigator full name: Jonathan Wu
  investigator title: Researcher
  mesh term: Musculoskeletal Diseases
  mesh term: Athletic Injuries
  sharing ipd: Yes
  ipd description: The individual participant data that results in a publication will be made available upon request.
  ipd time frame: information will be made available starting after publication. The information will be available for 3 years after publication.
  ipd access criteria: Criteria include other researchers interested in patient reported outcomes, for analyses related to telemedicine. Study coordinator will review requests for more data.
  provided document: 