Virtual Visits for Postoperative Care Following Urogynecologic Surgery

NCT05641077 | Completed Results

• 1 other identifier: 22-1269
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed VIDEO randomized trial will help inform clinical practice regarding the utility and perceived value of videoconferencing for postoperative care of urogynecologic patients by comparing patient satisfaction with virtual video visits and traditional in-office visits after pelvic organ prolapse and/or anti-incontinence surgery. Patient satisfaction will be measured by the Patient Satisfaction Questionnaire-18 at the 6-week postoperative visit. The investigators hypothesize that patient satisfaction with the virtual postoperative visit will be non-inferior to an in-office visit. The study will secondarily investigate other important components of healthcare quality, including safety and clinical outcomes, by comparing postoperative healthcare resource utilization and adverse events within 12 weeks after urogynecologic surgery. Healthcare resource utilization as measured by patient-initiated phone calls, unscheduled in-person/virtual office visits, emergency room or urgent care visits, and inpatient readmissions within 6 weeks following surgery and within 12 weeks following surgery. The study also aims to evaluate patient and provider preferences/attitudes toward in-office versus virtual-video postoperative visits.

Conditions

Satisfaction, Patient

Keywords

Urogynecology; Virtual visit; Telehealth; Urogynecologic surgery; Healthcare resource utilization; Patient satisfaction; Postoperative

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Patient satisfaction will be measured by the Patient Satisfaction Questionnaire-18 (PSQ-18) at the 6-week postoperative visit. The PSQ-18 is a validated 18-item questionnaire. Responses to each question are scored on a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score for the questionnaire ranges from 18 (dissatisfaction with medical care) to 90 (highest satisfaction with medical care).

  6 weeks

Study Arms (2)

Virtual Visit

EXPERIMENTAL

Patients randomized to the experimental arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.

Other: Virtual Visit

Office Visit

ACTIVE COMPARATOR

Patients randomized to the active comparator arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.

Other: Office Visit

Interventions

Virtual Visit OTHER

Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.

Virtual Visit

Office Visit OTHER

Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.

Office Visit

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Urogynecological post-operative study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years old
• Has technological capability to participate in videoconferencing (high-speed internet access with desktop computer or mobile device)
• Has decision-making capacity and able to provide informed consent for research participation
• Able to speak and read English

You may not qualify if:

• Patient requested to physically come in the office or have a virtual visit for her postoperative visit
• Planned concomitant surgery with another surgical team
• Office follow-up is deemed medically necessary by provider/surgeon

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Lua-Mailland LL, Nowacki AS, Paraiso MFR, Park AJ, Wallace SL, Ferrando CA. Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Oct 1;144(4):562-572. doi: 10.1097/AOG.0000000000005694. Epub 2024 Aug 8.

  PMID: 39116443 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Lannah Lua-Mailland
• Organization: Cleveland Clinic

lual@ccf.org

216-314-2163

Study Officials

• Cecile A Ferrando, M.D., M.P.H.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: January 20, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-06

Locations

US (1)