Virtual Visits for Postoperative Care Following Urogynecologic Surgery

Study Overview
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Brief Summary
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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 postoperative visit will be the same between the office and virtual groups. 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 and to determine if patient preparedness for surgery is associated with postoperative patient satisfaction and postoperative healthcare resource utilization.

Detailed Description
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The study is a randomized controlled trial evaluating patient satisfaction with in-office versus virtual-video postoperative visits at six weeks following urogynecologic surgery. The investigators aim to assess whether the intervention of virtual postoperative visit via videoconference technology is similar to the standard/traditional in-office postoperative visit for our primary outcome of patient satisfaction. 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 6-week visit, adverse events prior to postoperative visit), and twelve-week postoperative data (e.g. patient-initiated phone calls to surgeon's office, unanticipated outpatient visits, emergency department visits, hospital readmissions prior to 6-week visit, adverse events prior to postoperative visit). Power analysis is based on a randomized controlled study by Lee et al., which demonstrated a mean PSQ-18 score of 81.2 ± 2.8 in patients who had an in-person/office visit with the physician at approximately 30 days following their surgery. Assuming a SD=3, 74 patients will be needed to detect a difference of 2 points on the PSQ-18 between the office and virtual groups using t-test at a significance level of 0.05 and a power of 80%. To account for an attrition rate of 10%, a total of 82 participants will be needed for this study, with 41 women in the intervention arm and 41 women in the control arm. For the analysis plan, approximately normally-distributed continuous measures will be summarized using means and standard deviations and will be compared using two-sample t-tests. Continuous measures that show departure from normality and ordinal measures will be summarized using medians and quartiles and will be compared using Wilcoxon rank sum tests. Categorical factors will be summarized using frequencies and percentages and will be compared using Pearson's chi-square tests or Fisher's Exact tests. All analyses will be conducted with an a priori alpha level of 0.05; results yielding a p-value of less than 0.05 are deemed statistically significant. Data will be managed in REDCap and analyzed using the SAS 9.4 statistical package.

Official Title
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Are Virtual Visits for Delivery of Postoperative Care Following Urogynecologic Surgery Equal to Office Visits? The VIDEO Randomized Trial

Conditions
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Satisfaction, Patient

Intervention / Treatment
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* Other: Virtual Visit
* Other: Office Visit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Visit<br>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<br>* 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.<br>|
| Active Comparator: Office Visit<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healthcare resource utilization | 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 | 12 weeks | 
| Adverse events | Urinary tract infection, neurologic injury, hemorrhage/hematoma, blood transfusion, wound infection and cellulitis, seroma, abscess, pyelonephritis, sepsis, vaginal fistula, vaginal dehiscence, deep venous thrombosis, pneumonia, drainage of abscess, delayed gastrointestinal injury, delayed genitourinary injury, ileus, small bowel obstruction, pulmonary embolism, myocardial infarction, cerebrovascular accident and stroke, death, mesh complication, readmission, reoperation, and composite outcome utilizing Clavien-Dindo Grading System for surgical complications | 12 weeks | 
| Patient preferences/attitudes toward virtual or office visits | Patient and provider preferences/attitudes toward virtual or office visits will be evaluated based on responses to a questionnaire called Patient Postoperative Visit Questionnaire. This customized patient questionnaire has 7 items. Responses to each item include virtual visit is better, no difference, office visit is better, and does not apply to me. The questionnaire also includes an open-ended question, allowing the patient to select their preference for in-person or virtual visits for future postoperative visits and to specify their reason/s. | 6 weeks | 
| Provider preferences/attitudes toward virtual or office visits | Provider preferences/attitudes toward virtual or office visits will be evaluated based on responses to a questionnaire called Provider Postoperative Visit Preference Questionnaire. This customized provider questionnaire has 10 questions. Responses to each item include virtual visit is better, no difference, office visit is better, and does not apply to me. | 6 weeks | 
| Patient preparedness for surgery | Patient preparedness for surgery will be measured by the Patient Preparedness Questionnaire (PPQ) at the preoperative visit. The PPQ is a 11-item questionnaire scored on a six-point Likert scale and has responses ranging from 1 (strongly agree) to 6 (strongly disagree).9 The Patient Preparedness Questionnaire for this study will utilize the same six-point scale with a reversed scoring system, ranging from 1 (strongly disagree) to 6 (strongly agree). | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urogynecology, Virtual visit, Telehealth, Urogynecologic surgery, Healthcare resource utilization, Patient satisfaction, Postoperative