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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well patients feel prepared for a total laparoscopic hysterectomy. It compares pre-surgery counseling methods: traditional in-office visits and virtual visits via video. Individuals dealing with non-cancerous gynecological issues and scheduled for this surgery may qualify, provided they understand English and have access to the necessary technology for the virtual option. The researchers aim to determine whether virtual or in-office counseling better prepares patients for surgery. As an unphased trial, this study allows participants to contribute to enhancing patient preparation methods for surgery.

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 prior data suggests that this counseling method is safe for patient engagement in hysterectomy?

Research has shown that virtual and video counseling is safe and well-received. One study found that telehealth visits after gynecologic surgeries are not only safe but also satisfy patients. They appreciated the convenience of consulting their doctors without traveling. Another study demonstrated that virtual tools helped patients better understand their surgeries and feel more confident. These findings suggest that virtual and video counseling for surgery preparation is a good option, with no reports of negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different counseling methods can enhance patient engagement before a hysterectomy. Unlike the traditional in-office counseling sessions, the trial includes an innovative approach using video and virtual visits. This combination allows patients to receive consistent information from the comfort of their homes, potentially increasing their understanding and comfort level with the procedure. By leveraging technology, the trial aims to make pre-operative counseling more accessible and personalized, which could lead to better patient outcomes and satisfaction.

What evidence suggests that virtual and video pre-operative counseling is effective for patient engagement in hysterectomy?

Research shows that videos and virtual visits for pre-surgery counseling can enhance patients' understanding of their procedure. In this trial, participants in the Virtual Visit Group will receive pre-operative counseling via video, followed by a virtual visit with a gynecologic surgery provider. Studies have found that these tools also increase patient satisfaction. Specifically, past research indicated that patients who received video and virtual counseling felt more prepared for surgery. They reported feeling more informed and confident about what to expect. This suggests that video and virtual counseling might better prepare patients for their hysterectomy compared to traditional in-office counseling, which participants in the In-Office Visit Group will receive. ^{1 5 6 7 8}

Who Is on the Research Team?

Katrin Arnolds, MD

Principal Investigator

Cleveland Clinic Florida Gynecology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05086406

Virtual and Video Counseling Versus In-Office ... The proposed research study looks to evaluate the effectiveness of combination of video counseling and virtual visits for pre-operative counseling as compared ...

2. withpower.com withpower.com/trial/phase-4-2021-71141

Virtual/Video vs In-Office Counseling for Patient ... Research shows that using multimedia tools for preoperative education can improve patient understanding and satisfaction, as seen in studies involving ...

3. clinicaltrial.be clinicaltrial.be/en/details/37898?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Virtual and Video Counseling Versus In-Office Counseling... The proposed research study looks to evaluate the effectiveness of combination of video counseling and virtual visits for pre-operative ...

4. researchgate.net researchgate.net/publication/326038281_A_randomized_controlled_trial_to_determine_whether_a_video_presentation_improves_informed_consent_for_hysterectomy

A randomized controlled trial to determine whether a video ... Primary outcome was improvement in patient comprehension measured by assessments at baseline, post-counseling, day of surgery, and post-surgery. Patient ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05086406/virtual-and-video-counseling-versus-in-office-counseling-for-laparoscopic-hysterectomy

Virtual and Video Counseling Versus In-Office ... The proposed research study looks to evaluate the effectiveness of combination of video counseling and virtual visits for pre-operative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8801288/

Virtual postoperative visits following robotic gynecologic ... Telehealth visits following robotic gynecologic procedures appear to be safe and feasible, and are associated with a high level of patient satisfaction.

7. ajog.org ajog.org/article/S0002-9378(24)00211-4/pdf

Virtual appointments While several studies have reported the positive effect of virtual appointments on patient satisfaction and clinical efficiency, no prior work has described ...

8. mdpi.com mdpi.com/2072-6694/16/10/1913

A Preparatory Virtual Reality Experience Reduces Anxiety ... This study investigated whether using virtual reality (VR) could help reduce anxiety in women undergoing gynecological cancer surgery.