Virtual/Video vs In-Office Counseling for Patient Engagement in Hysterectomy

Overseen By Katrin Arnolds, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Age under 20, Malignancy, No technology access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

128 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Combination of Video and Virtual Pre-operative Counseling for patient engagement in hysterectomy?

Research shows that using multimedia tools for preoperative education can improve patient understanding and satisfaction, as seen in studies involving surgeries like endometrial cancer staging and knee arthroscopy. This suggests that video and virtual counseling could similarly enhance patient engagement and satisfaction for hysterectomy. ^{1 2 3 4 5}

Is virtual/video counseling safe for preoperative patient education?

Research on using videos and multimedia for preoperative education shows they are generally safe and can improve patient understanding and satisfaction. No specific safety concerns have been reported in these studies. ^{1 2 6 7 8}

How is the treatment of video and virtual pre-operative counseling for hysterectomy unique?

This treatment is unique because it combines video and virtual counseling to engage patients before a hysterectomy, potentially improving their understanding and satisfaction, similar to how multimedia tools have been used to enhance patient education in other surgeries. ^{1 2 3 4 9}

What is the purpose of this trial?

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

Research Team

Katrin Arnolds, MD

Principal Investigator

Cleveland Clinic Florida Gynecology

Eligibility Criteria

This trial is for English-speaking patients aged 20 or older who are preparing for a laparoscopic hysterectomy due to non-cancerous conditions. Participants must have access to technology for virtual communication and video watching.

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

Diagnosis of malignancy

Age less than 20 years old

No access to technology that would allow for watching counseling video and/or completion of virtual visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Counseling

Participants receive pre-operative counseling either via virtual visits and video or in-office visits

Up to time of surgery

1 visit (in-person or virtual)

Surgery

Participants undergo total laparoscopic hysterectomy

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

6 weeks

Treatment Details

Interventions

• Combination of Video and Virtual Pre-operative Counseling

Trial Overview The study compares how well patients get ready for total laparoscopic hysterectomies when they receive pre-operative counseling virtually (through videos and online meetings) versus the traditional in-office visits.

Participant Groups

Group I: Virtual Visit Group Experimental Treatment 1 Intervention

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 II: In-Office Visit Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

The use of a mobile health patient engagement technology (PET) in gynecologic oncology patients led to a significant reduction in hospital length of stay (LOS), averaging 2.9 days compared to 3.6 days in the control group.

Patients using the PET also experienced a 50% lower readmission rate (4.3% vs. 8.6%), indicating that the technology effectively improved postoperative outcomes and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a mobile health patient engagement technology improves perioperative outcomes in gynecologic oncology patients. Boitano, TKL., Gardner, A., Chu, DI., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of standard versus multimedia-supplemented counseling in patients undergoing endometrial cancer staging surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Use of a mobile health patient engagement technology improves perioperative outcomes in gynecologic oncology patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Can digital engagement improve outcomes for total joint replacements? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Web-Based Education Prior to Knee Arthroscopy Enhances Informed Consent and Patient Knowledge Recall: A Prospective, Randomized Controlled Study. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

The effect of an informative 360-degree virtual reality video on anxiety for women visiting the one-stop clinic for abnormal uterine bleeding: A randomized controlled trial (VISION-trial). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The use of a video to convey preanesthetic information to patients undergoing ambulatory surgery. [2022]

8. Scotland pubmed.ncbi.nlm.nih.gov

Informed consent in oral and maxillofacial surgery: a study of the value of written warnings. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Novel, Automated Text-Messaging System Is Effective in Patients Undergoing Total Joint Arthroplasty. [2019]