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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05086406
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31.9
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Engagement	Other: Combination of Video and Virtual Pre-operative Counseling	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy: A Randomized Controlled Trial
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Dec 28, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Differences in patient preparedness [Up to time of surgery]

   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.

Secondary Outcome Measures

1. Unplanned office or emergency department visit [Up to 6 weeks after surgery]

   Observe how many patients from each cohort require an unplanned visit to the office or visit to the emergency department.

2. Same-day discharge versus admission rates [Up to 1 day after surgery]

   Note differences in same-day discharges or admission rates following surgery between each cohort

3. Readmission rates [Up to 6 weeks after surgery]

   Record differences in readmission rates in the 6 week post-operative period between each cohort.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Florida	Weston	Florida	United States	33331

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT05086406
• Other Study ID Numbers: FLA 21-022
• First Posted: Oct 20, 2021
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Cleveland Clinic: Patient Preparedness; Total Laparoscopic Hysterectomy; Pre-operative Education; Virtual Visits/Counseling

Study Results

No Results Posted as of Jul 5, 2022