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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Patient Engagement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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In-Office Visit Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Combination of Video and Virtual Pre-operative Counseling

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes