Clinical trial NCT03258177: Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)
Official title: Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendectomy, Laparoscopic
Cholecystectomy, Laparoscopic
Cholecystectomy, Robotic
Keywords: Virtual Visits
Telehealth
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American College of Surgeons
First posted: 2017-08-23
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Composite measure of the occurrence of hospital encounters
timeFrame: from date of surgery until the date of 30 days after surgery
Secondary outcomes:
measure: Postoperative follow-up visit time length in minutes
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Patient satisfaction score
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Patient convenience score
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Rate of postoperative follow-up
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Rate of postoperative no-shows
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Patient travel time to clinic in minutes
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
measure: Patient cost savings in dollars
timeFrame: date of follow-up visit, approximately 14 days after date of surgery
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health- Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Caroline Reinke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.