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Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)

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ClinicalTrials.gov Identifier: NCT03258177
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Caroline E. Reinke, Atrium Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Appendectomy, Laparoscopic Cholecystectomy, Laparoscopic Cholecystectomy, Robotic Other: Virtual Visit Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Virtual Visit Group
Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit.
Other: Virtual Visit
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.

No Intervention: Standard In-person Group
Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit.



Primary Outcome Measures :
  1. Composite measure of the occurrence of hospital encounters [ Time Frame: from date of surgery until the date of 30 days after surgery ]
    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


Secondary Outcome Measures :
  1. Postoperative follow-up visit time length in minutes [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    total time of postoperative follow-up visit in minutes

  2. Patient satisfaction score [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    self-reported patient satisfaction rating for follow-up visit assessed by survey

  3. Patient convenience score [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    self-reported patient convenience rating for follow-up visit assessed by survey

  4. Rate of postoperative follow-up [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    percent of patients who receive a postoperative follow-up visit

  5. Rate of postoperative no-shows [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    percent of scheduled postoperative follow-up appointments in which patients do not complete

  6. Patient travel time to clinic in minutes [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    total patient travel time from home to postoperative follow-up clinic in minutes

  7. Patient cost savings in dollars [ Time Frame: date of follow-up visit, approximately 14 days after date of surgery ]
    Patient gas cost savings for travel from home to postoperative follow-up clinic



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to comply with all study procedures and be available for the duration of the study
  • English speaking
  • Able to read
  • Have an email address
  • Scheduled to undergo a laparoscopic appendectomy, laparoscopic cholecystectomy or robotic cholecystectomy OR have undergone an unplanned (urgent or emergent) laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy
  • Have surgery performed by a surgeon at either Carolinas Medical Center-Main or Carolinas Medical Center- Mercy who provides emergency general surgery clinical coverage
  • Live in North Carolina

Exclusion Criteria:

  • Unable to complete a virtual visit (due to lack of appropriate technology, necessary technology skills, other);
  • Medical condition, laboratory finding, or physical exam finding that precludes participation (patients at high risk for complications, particularly those with perforated appendicitis)
  • Postoperative length of stay greater than or equal to 4 days
  • Discharged with drains that need to be removed at a postoperative visit
  • Admitted from or discharged to assisted living facility, skilled nursing facility, or location other than home
  • Have chronic pain for which the participant takes narcotic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258177


Contacts
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Contact: Nicole Kaiser 704-355-7630 nicole.kaiser@carolinashealthcare.org

Locations
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United States, North Carolina
Atrium Health- Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Nicole Kaiser    704-355-7630      
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Caroline Reinke, MD Atrium Health

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Responsible Party: Caroline E. Reinke, Assistant Professor of Surgery, Atrium Health
ClinicalTrials.gov Identifier: NCT03258177     History of Changes
Other Study ID Numbers: 07-17-14E
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Caroline E. Reinke, Atrium Health:
Virtual Visits
Telehealth