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CompletedNCT03258177Updated Aug 10, 2022

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

An interventional study of Virtual Visit in Appendectomy, Laparoscopic, Cholecystectomy, Laparoscopic and Cholecystectomy, Robotic, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Appendectomy, Laparoscopic
  • Cholecystectomy, Laparoscopic
  • Cholecystectomy, Robotic

Keywords

  • Virtual Visits
  • Telehealth
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 or South Carolina

Exclusion criteria

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, patients with active cocaine abuse)
  • 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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherVirtual 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.

05

What researchers measure

Primary outcomes

  1. Composite measure of the occurrence of hospital encounters

    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

    Time frame: from date of surgery until the date of 30 days after surgery

Secondary outcomes

  1. Postoperative follow-up visit time length in minutes

    total time of postoperative follow-up visit in minutes

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  2. Patient satisfaction score

    self-reported patient satisfaction rating for follow-up visit assessed by survey

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  3. Patient convenience score

    self-reported patient convenience rating for follow-up visit assessed by survey

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  4. Rate of postoperative follow-up

    percent of patients who receive a postoperative follow-up visit

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  5. Rate of postoperative no-shows

    percent of scheduled postoperative follow-up appointments in which patients do not complete

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  6. Patient travel time to clinic in minutes

    total patient travel time from home to postoperative follow-up clinic in minutes

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

  7. Patient cost savings in dollars

    Patient gas cost savings for travel from home to postoperative follow-up clinic

    Time frame: date of follow-up visit, approximately 14 days after date of surgery

06

Study locations

1 site
  • Atrium Health- Carolinas Medical Center
    Charlotte, North Carolina 28203, United States
07

References and documents

Publications

  • Harkey K, Connor CD, Wang H, Kaiser N, Matthews BD, Kelz R, Reinke CE. View from the Patient Perspective: Mixed-Methods Analysis of Post-Discharge Virtual Visits in a Randomized Controlled Trial. J Am Coll Surg. 2021 Nov;233(5):593-605.e4. doi: 10.1016/j.jamcollsurg.2021.07.688. Epub 2021 Sep 9. PubMed 34509613 ↗
  • Harkey K, Kaiser N, Zhao J, Hetherington T, Gutnik B, Matthews BD, Kelz RR, Reinke CE. Postdischarge Virtual Visits for Low-risk Surgeries: A Randomized Noninferiority Clinical Trial. JAMA Surg. 2021 Mar 1;156(3):221-228. doi: 10.1001/jamasurg.2020.6265. PubMed 33439221 ↗

Study documents

  • Informed consent form · Jul 9, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03258177
Lead sponsor
Wake Forest University Health Sciences
Collaborators
American College of Surgeons
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Aug 18, 2017
Primary completion
Apr 10, 2020
Completion
May 10, 2020
Last update
Aug 10, 2022

Study contacts

Caroline Reinke, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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