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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03258177
Other study ID # IRB00082477
Secondary ID 07-17-14E
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2017
Est. completion date May 10, 2020

Study information

Verified date September 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date May 10, 2020
Est. primary completion date April 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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: - 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Atrium Health- Carolinas Medical Center Charlotte North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences American College of Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 from date of surgery until the date of 30 days after surgery
Secondary Postoperative follow-up visit time length in minutes total time of postoperative follow-up visit in minutes date of follow-up visit, approximately 14 days after date of surgery
Secondary Patient satisfaction score self-reported patient satisfaction rating for follow-up visit assessed by survey date of follow-up visit, approximately 14 days after date of surgery
Secondary Patient convenience score self-reported patient convenience rating for follow-up visit assessed by survey date of follow-up visit, approximately 14 days after date of surgery
Secondary Rate of postoperative follow-up percent of patients who receive a postoperative follow-up visit date of follow-up visit, approximately 14 days after date of surgery
Secondary Rate of postoperative no-shows percent of scheduled postoperative follow-up appointments in which patients do not complete date of follow-up visit, approximately 14 days after date of surgery
Secondary Patient travel time to clinic in minutes total patient travel time from home to postoperative follow-up clinic in minutes date of follow-up visit, approximately 14 days after date of surgery
Secondary Patient cost savings in dollars Patient gas cost savings for travel from home to postoperative follow-up clinic date of follow-up visit, approximately 14 days after date of surgery
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