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

August 5, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from date of surgery until the date of 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery
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
date of follow-up visit, approximately 14 days after date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

American College of Surgeons

Investigators

  • Principal Investigator: Caroline Reinke, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 18, 2017

Primary Completion (ACTUAL)

April 10, 2020

Study Completion (ACTUAL)

May 10, 2020

Study Registration Dates

First Submitted

August 20, 2017

First Submitted That Met QC Criteria

August 20, 2017

First Posted (ACTUAL)

August 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00082477
  • 07-17-14E (OTHER: Atrium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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