Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy

NCT05086406 | Active Not Recruiting

• 1 other identifier: FLA 21-022
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Compare preparedness for total laparoscopic hysterectomies between patients who undergo virtual visits and those who undergo in-office visits for pre-operative counseling.

Conditions

Patient Engagement

Keywords

Patient Preparedness; Total Laparoscopic Hysterectomy; Pre-operative Education; Virtual Visits/Counseling

Outcome Measures

Primary Outcomes (1)

• Differences in patient preparedness

  Assess differences in patient preparedness at the time of the surgery between patients who received video and virtual pre-operative counseling versus those who received in-person counseling.

  Up to time of surgery

Secondary Outcomes (3)

• Unplanned office or emergency department visit

  Up to 6 weeks after surgery

• Same-day discharge versus admission rates

  Up to 1 day after surgery

• Readmission rates

  Up to 6 weeks after surgery

Study Arms (2)

In-Office Visit Group

NO INTERVENTION

This control group will undergo standard in-office pre-operative counseling visit.

Virtual Visit Group

EXPERIMENTAL

This study group will receive pre-operative counseling via video, created by the Department of Gynecology at Cleveland Clinic Florida, followed by a virtual visit with a gynecologic surgery provider.

Other: Combination of Video and Virtual Pre-operative Counseling

Interventions

Combination of Video and Virtual Pre-operative Counseling OTHER

Intervention will be a pre-operative counseling video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications.

Virtual Visit Group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing laparoscopic hysterectomy for benign gynecologic etiologies.
• Age of 20 years or older
• Understand English language (written and spoken) without difficulty

You may not qualify if:

• Age less than 20 years old
• Diagnosis of malignancy
• No access to technology that would allow for watching counseling video and/or completion of virtual visit

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (5)

• Krantz TE, Rogers RG, Petersen TR, Dunivan GC, White AB, Madsen AM, Jeppson PC, Ninivaggio CS, Cichowski SB, Komesu YM. Peer-Centered Versus Standard Physician-Centered Video Counseling for Midurethral Sling Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2020 Aug;26(8):470-476. doi: 10.1097/SPV.0000000000000784.

  PMID: 31596774 BACKGROUND

• Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18.

  PMID: 28431952 BACKGROUND

• Fountain CR, Havrilesky LJ. Promoting Same-Day Discharge for Gynecologic Oncology Patients in Minimally Invasive Hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-939. doi: 10.1016/j.jmig.2017.05.005. Epub 2017 May 10.

  PMID: 28501452 BACKGROUND

• Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.

  PMID: 18060968 BACKGROUND

• Brubaker L, Litman HJ, Rickey L, Dyer KY, Markland AD, Sirls L, Norton P, Casiano E, Paraiso MF, Ghetti C, Rahn DD, Kusek JW. Surgical preparation: are patients "ready" for stress urinary incontinence surgery? Int Urogynecol J. 2014 Jan;25(1):41-6. doi: 10.1007/s00192-013-2184-x. Epub 2013 Aug 3.

  PMID: 23912506 BACKGROUND

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Katrin Arnolds, MD

  Cleveland Clinic Florida Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients undergoing a laparoscopic hysterectomy for benign gynecologic etiologies with Drs. Arnolds, Frazzini Padilla, or Sprague at Cleveland Clinic Florida Section of Minimally Invasive Gynecologic Surgery will be recruited at the visit where decision is made to proceed with surgery. Enrolled subjects will be randomized using a computer generator into either the control group or the study group. Subjects will be notified of which group they have been selected to at the time of scheduling for their pre-operative visit. The control group will undergo standard in-office pre-operative counseling visit. The study group will receive pre-operative counseling via video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications that are currently approved by Cleveland Clinic. The link to the video and instructions for the virtual visit will be sent to the subject either via email and/or through a message on the electronic medical record platform.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 20, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)