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

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

Detailed Description
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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.

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

Conditions
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Patient Engagement

Intervention / Treatment
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* Other: Combination of Video and Virtual Pre-operative Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Preparedness, Total Laparoscopic Hysterectomy, Pre-operative Education, Virtual Visits/Counseling