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

Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Patient Engagement
• Intervention / Treatment: Other: Combination of Video and Virtual Pre-operative Counseling

Detailed Description

The proposed research study looks to evaluate the effectiveness of combination of video counseling and virtual visits for pre-operative counseling as compared to in-office pre-operative counseling visits ahead of total laparoscopic hysterectomy surgery. Comparison of the two cohorts will be based on responses to surveys regarding patient preparedness on the day of surgery and information obtained from the electronic medical record.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George K Thomas, MD; Phone Number: 757-817-0353; Email: thomasg6@ccf.org
• Study Contact Backup: Name: Katrin Arnolds, MD; Phone Number: 305-389-6658; Email: arnoldk@ccf.org

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: George K Thomas, MD; Phone Number: 757-817-0353; Email: thomasg6@ccf.org
      • Contact: Katrin Arnolds, MD; Phone Number: 305-389-6658; Email: arnoldk@ccf.org
      • Principal Investigator: Katrin Arnolds, MD
      • Sub-Investigator: George K Thomas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: In-Office Visit Group; This control group will undergo standard in-office pre-operative counseling visit.
Experimental: Virtual Visit Group; 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; Intervention will be a pre-operative counseling video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned office or emergency department visit	Observe how many patients from each cohort require an unplanned visit to the office or visit to the emergency department.	Up to 6 weeks after surgery
Same-day discharge versus admission rates	Note differences in same-day discharges or admission rates following surgery between each cohort	Up to 1 day after surgery
Readmission rates	Record differences in readmission rates in the 6 week post-operative period between each cohort.	Up to 6 weeks after surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Katrin Arnolds, MD, Cleveland Clinic Florida Gynecology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Patient Preparedness; Total Laparoscopic Hysterectomy; Pre-operative Education; Virtual Visits/Counseling
• Other Study ID Numbers: FLA 21-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers. The goal of the study is to look at outcomes of each cohort and it is not necessary to analyze each IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No