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

NCT03258177 | Completed DMC

• 2 other identifiers: IRB0008247707-17-14E
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendectomy, Laparoscopic; Cholecystectomy, Laparoscopic; Cholecystectomy, Robotic

Keywords

Virtual Visits; Telehealth

Outcome Measures

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

  from date of surgery until the date of 30 days after surgery

Secondary Outcomes (7)

• Postoperative follow-up visit time length in minutes

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

• Patient satisfaction score

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

• Patient convenience score

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

• Rate of postoperative follow-up

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

• Rate of postoperative no-shows

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

Study Arms (2)

Virtual Visit Group

EXPERIMENTAL

Participants assigned to the virtual visit group will receive a virtual visit as their postoperative follow-up visit.

Other: Virtual Visit

Standard In-person Group

NO INTERVENTION

Participants assigned to the standard in-person group will receive an in-person follow-up visit as their postoperative follow-up visit.

Interventions

Virtual Visit OTHER

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.

Virtual Visit Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American College of Surgeons: collaborator

Study Sites (1)

Atrium Health- Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (2)

• 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.

  PMID: 34509613 DERIVED

• 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.

  PMID: 33439221 DERIVED

Study Officials

• Caroline Reinke, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 23, 2017
• Study Start: August 18, 2017
• Primary Completion: April 10, 2020
• Study Completion: May 10, 2020
• Last Updated: August 10, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)