Virtual Visits for Postoperative Care Following Urogynecologic Surgery

NCT ID: NCT05641077

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2024-01-31

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.

Detailed Description

The study is a randomized controlled noninferiority trial evaluating patient satisfaction with in-office versus virtual-video postoperative visits at six weeks following urogynecologic surgery. We aim to assess whether the intervention of virtual postoperative visit via videoconference technology is noninferior to the standard/traditional in-office postoperative visit for our primary outcome of patient satisfaction. The recruitment period will be 15 months (January 1, 2023 to March 31, 2024). The follow-up period for each participant will be 12 weeks after surgery.

The investigators will recruit patients of the Center for Urogynecology and Pelvic Reconstructive Surgery in the Department of Obstetrics/Gynecology and Women's Health Institute at the Cleveland Clinic scheduled to undergo major or minor surgery for pelvic organ prolapse and/or urinary incontinence. Participants will be prospectively identified by the primary surgeon during the patient's initial consultation when the decision is made to proceed with surgery for pelvic organ prolapse and/or urinary incontinence. Enrolled participants will be randomized to either the office visit arm or the virtual visit arm. Stratified block randomization will be used to ensure that the number of participants is equally distributed among the study groups and stratified by surgery level (major, minor).

Study instruments will be administered at the preoperative visit and the 6-week postoperative visit. The questionnaires for this study include the Patient Preparedness Questionnaire (PPQ), the Patient Satisfaction Questionnaire-18 (PSQ-18), and modified patient and provider preference questionnaires entitled, Patient Postoperative Visit Questionnaire and Provider Postoperative Visit Preference Questionnaire.

In addition to questionnaire responses, the investigators will collect the following information from the electronic medical record: Demographic data (e.g. age, race, parity, body mass index), perioperative data (e.g. surgery level major/minor, surgery type, concomitant procedures, estimated blood loss, operative time), six-week postoperative data (e.g. route of postoperative visit in-office/virtual, patient-initiated phone calls to surgeon's office, unanticipated outpatient visits, emergency department visits, hospital readmissions prior to the postoperative visit, adverse events prior to postoperative visit), and 6-12 week postoperative data (e.g. patient-initiated phone calls to surgeon's office, unanticipated outpatient visits, emergency department visits, hospital readmissions, and adverse events after the scheduled postoperative visit for up to 12 weeks after surgery).

A priori sample size calculation determined that 100 participants (50 per group) would allow for 80% power to assess a noninferiority margin of 5 points on the total PSQ-18, with a SD of 10 and significance level of 0.05. A minimum important difference has not been reported for the PSQ-18; however, previous studies using this tool demonstrated SD for total PSQ-18 score ranging between 2.6 and 11.8 and used a 5-point interval for the noninferiority margin. To account for an anticipated attrition rate of approximately 5%, we aimed to enroll a total of 106 participants (53 per group).

Patient satisfaction (PSQ-18) total scores, as well scores in each of the 7 PSQ-18 domains, will be treated as continuous data and checked for normality. Healthcare utilization will be analyzed individually (number of phone calls, number of outpatient visits, number of emergency department or urgent care visits, number of hospital readmissions), as well as a composite of all encounter types. Adverse events will be analyzed independently but also as a composite utilizing the Clavien-Dindo Grading System for surgical complications. Attitudes toward office/virtual visits will be analyzed by comparing proportions of patients and providers who prefer a virtual visit, prefer an office visit, or have no preference.

All analyses will be conducted using an intention-to-treat principle. Baseline demographic and clinical characteristics will be summarized using descriptive statistics. Normally-distributed continuous measures will be summarized using mean and standard deviation (SD), whereas those showing departure from normality will be summarized using median and interquartile range (IQR). Categorical measures will be summarized using number of participants and percentage. The primary end-point analysis will be designed to test whether patient satisfaction with a virtual postoperative visit is noninferior to an in-person postoperative visit, as determined by the total PSQ-18 at the scheduled postoperative visit. Noninferiority would be shown if the lower limit of the two-sided 95% confidence interval for the between-group mean difference in the primary endpoint (i.e., the difference between the mean PSQ-18 total score in the virtual group minus the mean PSQ-18 total score in the in-office group) is more than -5 points. Similar analyses will be performed for each secondary outcome. The noninferiority margin is defined as 5 points for the PSQ-18 total score and 0.5 points for the PSQ-18 domain scores, 10% absolute for composite healthcare resource utilization, and 25% absolute for composite adverse events. Planned exploratory subgroup analyses of patient satisfaction, healthcare resource utilization and adverse events based on surgery level will be additionally performed. All statistical analyses will be performed using JMP Pro version 17.0 software (SAS Institute, Cary, NC). Data will be managed in REDCap. Statistical support will be provided by the Cleveland Clinic Quantitative Health Sciences.

Conditions

Satisfaction, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Visit

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.

Group Type: EXPERIMENTAL

Virtual Visit

Intervention Type: 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.

Office Visit

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.

Group Type: ACTIVE_COMPARATOR

Office Visit

Intervention Type: 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.

Interventions

Virtual Visit

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.

Intervention Type: OTHER

Office Visit

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecile A Ferrando, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39116443 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

22-1269

Identifier Type: -

Identifier Source: org_study_id