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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrin Arnolds, MD | Cleveland Clinic Florida Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31596774 | Background | 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. | |
| 28431952 |
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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.
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
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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 |
| 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. |
| 28501452 | 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. |
| 18060968 | 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. |
| 23912506 | 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. |