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

NCT ID: NCT03258177

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-18
• Study Completion Date: 2020-05-10

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.

Conditions

Appendectomy, Laparoscopic; Cholecystectomy, Laparoscopic; Cholecystectomy, Robotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Virtual Visit Group

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

Group Type: EXPERIMENTAL

Virtual Visit

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Surgeons

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Reinke, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health- Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34509613 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33439221 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

07-17-14E

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082477

Identifier Type: -

Identifier Source: org_study_id