<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/NCT03258177</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00082477</org_study_id>
    <secondary_id>07-17-14E</secondary_id>
    <nct_id>NCT03258177</nct_id>
  </id_info>
  <brief_title>Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)</brief_title>
  <official_title>Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Surgeons</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to implement and evaluate postoperative virtual care visits for&#xD;
      patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic&#xD;
      cholecystectomy. The investigators aim to better understand whether postoperative virtual&#xD;
      care visits will not result in a greater composite measure of the occurrence of hospital&#xD;
      encounters within Atrium Health (AH) for the 30 days following surgery than standard&#xD;
      in-person clinic care. The investigators also aim to better understand whether postoperative&#xD;
      virtual care visits provide time and cost savings, and provide equal or improved patient&#xD;
      satisfaction and convenience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to complete either a postoperative follow-up visit using&#xD;
      virtual care technology or by attending a standard in-person visit at the clinic. The virtual&#xD;
      visit uses a camera-enabled device and internet access to provide live access to the medical&#xD;
      professional. Surveys to assess patient satisfaction and convenience will be administered by&#xD;
      email on the day of the postoperative follow-up visit. Additional information including&#xD;
      demographics, hospital encounters within 30 days of surgery, length of time of the follow-up&#xD;
      visit, travel cost and time, whether additional follow-up care is required, and complications&#xD;
      after surgery will be collected to evaluate postoperative virtual care visits. Subject&#xD;
      participation in the study will end after follow-up care is complete or at 30 days, whichever&#xD;
      occurs last.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">May 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 10, 2020</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>Composite measure of the occurrence of hospital encounters</measure>
    <time_frame>from date of surgery until the date of 30 days after surgery</time_frame>
    <description>composite measure of the occurrence of hospital encounters for the 30 days following surgery including all-cause and any-site inpatient, observational, and emergency department visits within Carolinas HealthCare System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative follow-up visit time length in minutes</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>total time of postoperative follow-up visit in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>self-reported patient satisfaction rating for follow-up visit assessed by survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient convenience score</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>self-reported patient convenience rating for follow-up visit assessed by survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative follow-up</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>percent of patients who receive a postoperative follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative no-shows</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>percent of scheduled postoperative follow-up appointments in which patients do not complete</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient travel time to clinic in minutes</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>total patient travel time from home to postoperative follow-up clinic in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient cost savings in dollars</measure>
    <time_frame>date of follow-up visit, approximately 14 days after date of surgery</time_frame>
    <description>Patient gas cost savings for travel from home to postoperative follow-up clinic</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Appendectomy, Laparoscopic</condition>
  <condition>Cholecystectomy, Laparoscopic</condition>
  <condition>Cholecystectomy, Robotic</condition>
  <arm_group>
    <arm_group_label>Virtual Visit Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard In-person Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Visit</intervention_name>
    <description>Participants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit.</description>
    <arm_group_label>Virtual Visit Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to read&#xD;
&#xD;
          -  Have an email address&#xD;
&#xD;
          -  Scheduled to undergo a laparoscopic appendectomy, laparoscopic cholecystectomy or&#xD;
             robotic cholecystectomy OR have undergone an unplanned (urgent or emergent)&#xD;
             laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy&#xD;
&#xD;
          -  Have surgery performed by a surgeon at either Carolinas Medical Center-Main or&#xD;
             Carolinas Medical Center- Mercy who provides emergency general surgery clinical&#xD;
             coverage&#xD;
&#xD;
          -  Live in North Carolina or South Carolina&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete a virtual visit (due to lack of appropriate technology, necessary&#xD;
             technology skills, other);&#xD;
&#xD;
          -  Medical condition, laboratory finding, or physical exam finding that precludes&#xD;
             participation (patients at high risk for complications, particularly those with&#xD;
             perforated appendicitis, patients with active cocaine abuse)&#xD;
&#xD;
          -  Postoperative length of stay greater than or equal to 4 days&#xD;
&#xD;
          -  Discharged with drains that need to be removed at a postoperative visit&#xD;
&#xD;
          -  Admitted from or discharged to assisted living facility, skilled nursing facility, or&#xD;
             location other than home&#xD;
&#xD;
          -  Have chronic pain for which the participant takes narcotic medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Reinke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atrium Health- Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Visits</keyword>
  <keyword>Telehealth</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03258177/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03258177
org study id: IRB00082477
secondary id: 07-17-14E
nct id: NCT03258177
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to implement and evaluate postoperative virtual care visits for
      patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic
      cholecystectomy. The investigators aim to better understand whether postoperative virtual
      care visits will not result in a greater composite measure of the occurrence of hospital
      encounters within Atrium Health (AH) for the 30 days following surgery than standard
      in-person clinic care. The investigators also aim to better understand whether postoperative
      virtual care visits provide time and cost savings, and provide equal or improved patient
      satisfaction and convenience.
Participants will be randomized to complete either a postoperative follow-up visit using
      virtual care technology or by attending a standard in-person visit at the clinic. The virtual
      visit uses a camera-enabled device and internet access to provide live access to the medical
      professional. Surveys to assess patient satisfaction and convenience will be administered by
      email on the day of the postoperative follow-up visit. Additional information including
      demographics, hospital encounters within 30 days of surgery, length of time of the follow-up
      visit, travel cost and time, whether additional follow-up care is required, and complications
      after surgery will be collected to evaluate postoperative virtual care visits. Subject
      participation in the study will end after follow-up care is complete or at 30 days, whichever
      occurs last.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Composite measure of the occurrence of hospital encounters
time frame: from date of surgery until the date of 30 days after surgery
description: composite measure of the occurrence of hospital encounters for the 30 days following surgery including all-cause and any-site inpatient, observational, and emergency department visits within Carolinas HealthCare System
measure: Postoperative follow-up visit time length in minutes
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: total time of postoperative follow-up visit in minutes
measure: Patient satisfaction score
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: self-reported patient satisfaction rating for follow-up visit assessed by survey
measure: Patient convenience score
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: self-reported patient convenience rating for follow-up visit assessed by survey
measure: Rate of postoperative follow-up
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: percent of patients who receive a postoperative follow-up visit
measure: Rate of postoperative no-shows
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: percent of scheduled postoperative follow-up appointments in which patients do not complete
measure: Patient travel time to clinic in minutes
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: total patient travel time from home to postoperative follow-up clinic in minutes
measure: Patient cost savings in dollars
time frame: date of follow-up visit, approximately 14 days after date of surgery
description: Patient gas cost savings for travel from home to postoperative follow-up clinic
arm group label: Virtual Visit Group
arm group type: Experimental
description: Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit.
arm group label: Standard In-person Group
arm group type: No Intervention
description: Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit.
intervention type: Other
intervention name: Virtual Visit
description: Participants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit.
arm group label: Virtual Visit Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Caroline Reinke, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 