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

Patient Engagement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086406
• Other study ID #: FLA 21-022
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 28, 2023

Study information

• Verified date: July 2022
• Source: The Cleveland Clinic
• Contact: George K Thomas, MD
• Phone: 757-817-0353
• Email: thomasg6[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 28, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Engagement

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Readmission rates	Record differences in readmission rates in the 6 week post-operative period between each cohort.	Up to 6 weeks after surgery