Are Virtual Visits for Delivery of Postoperative Care Following Urogynecologic Surgery Equal to Office Visits? The VIDEO Randomized Trial
Phase: NA
Conditions: Satisfaction, Patient
Sponsor: The Cleveland Clinic

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Study Title:  
 
Are Virtual Visits for Delivery of Postoperative Care Following Urogynecologic Surgery Equal to 
Office Visits? The VIDEO Randomized Trial 
 
 
Principal Investigators:  
 
Cecile Ferrando, MD MPH: Associate Professor. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Lannah Lorraine Lua-Mailland, MD MPH: Fellow in Female Pelvic Medicine and Reconstructive 
Surgery. Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology 
and Women’s Health Institute at Cleveland Clinic 
 
 
Co-Investigators:  
 
Marie Fidela Paraiso, MD: Staff. Center for Urogynecology and Pelvic Reconstructive Surgery; 
Obstetrics/Gynecology and Women’s Health Institute at Cleveland Clinic 
 
Amy Park, MD: Section Head. Center for Urogynecology and Pelvic Reconstructive Surgery; 
Obstetrics/Gynecology and Women’s Health Institute at Cleveland Clinic 
 
Shannon Wallace, MD: Staff. Center for Urogynecology and Pelvic Reconstructive Surgery; 
Obstetrics/Gynecology and Women’s Health Institute at Cleveland Clinic 
 
Abigail Anderson, APRN CNP: Nurse Practitioner. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Michelle Miller, APRN CNP: Nurse Practitioner. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Natalie Weigand, APRN CNP; Nurse Practitioner. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
 
Sponsor, if Applicable (include NIH and other funding sources here): Research Program 
Committees and Obstetrics and Gynecology Institute 
 
 
 
 

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A. BACKGROUND AND SIGNIFICANCE 
 
Telehealth refers to the dissemination of health-related information, delivering services such 
as remove patient monitoring, and the provision of clinical care to patients via 
telecommunications technology such as telephone, video conferencing, text messaging, and 
email.1 The pandemic has catalyzed rapid adoption of telehealth, with an increase in the 
proportion of telehealth visits in some healthcare systems from less than 100 too greater than 
600 video visits per day.2 Telehealth increases efficiency and access to health services. 
Although face-to-face interactions may be preferred in some circumstances, telehealth visits can 
improve access to healthcare for patients with transportation challenges, work schedule 
limitations, or physical disability and may be considered as an alternative to office visits.2-3 
 
Delivery of postoperative care via telehealth platforms has been successfully incorporated 
into other fields such as urology, pediatric surgery, and general surgery.4-5 Interactive, face-to-
face contact between patient and provider in real-time through videoconferencing allows for 
examination of surgical sites, catheters and other drains, in addition to discussion of surgical 
recovery. Prior studies suggest that telehealth enhances patient satisfaction and improves 
patient engagement and adherence with care.1,6-7 When compared with traditional methods of 
healthcare delivery, telehealth provides comparable health outcomes without compromising the 
patient-physician relationship.1 
 
Telehealth has immense potential to improve healthcare quality by improving patient 
satisfaction and clinical outcomes while minimizing adverse events. Postoperative patient 
satisfaction is an indicator of overall surgical quality of care.4,6 Studies focusing on patient-
centered outcomes associated with videoconference technology for delivery of postoperative 
care following pelvic reconstructive surgery are limited. To date, only two randomized controlled 
trials have been published evaluating patient satisfaction with telehealth visits in the 
urogynecologic population.4,6 The intervention evaluated by Thompson et al. was limited to 
telephone visits only for postoperative follow-up.4 The study by Lee et al. included only patients 
undergoing pelvic organ prolapse surgery with a follow-up call placed 48 to 72 hours after 
discharge and both video and in-person groups returning to the office at 90 days after surgery; 
patient satisfaction was evaluated at the 30-day in-person versus virtual visit.6 Both trials 
demonstrated that postoperative telehealth visits were non-inferior to traditional in-office visits 
based on patient satisfaction; with no difference in healthcare utilization, complication rates, or 
clinical outcomes based on validated questionnaires. Additionally, several studies have 
demonstrated a positive correlation between patient preparedness for pelvic organ prolapse 
and/or anti-incontinence surgery and postoperative satisfaction, perioperative outcomes, 
postoperative symptom and quality of life improvement, and perceived complications.8-10 
 
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. 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. 

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B. SPECIFIC AIMS 
 
Primary aim:  
• To compare patient satisfaction with their postoperative visit between patients receiving 
in-office versus virtual-video postoperative visits at 6 weeks after surgery. 
We hypothesize that patient satisfaction with a virtual postoperative visit will be 
noninferior to patient satisfaction with an in-office postoperative visit 
 
Secondary aims: 
• To compare healthcare resource utilization after the postoperative visit up to 12 weeks 
following urogynecologic surgery between patients receiving in-office versus virtual-video 
postoperative visits. 
We hypothesize that the virtual group will be noninferior to the in-office group based on 
healthcare resource utilization after the postoperative visit up to 12 weeks following 
surgery. 
 
• To compare adverse events after the postoperative visit up to 12 weeks following 
urogynecologic surgery between patients receiving in-office versus virtual-video six-week 
postoperative visits. 
We hypothesize that the virtual group will be noninferior to the in-office group based on 
adverse events after the postoperative visit up to 12 weeks following surgery. 
 
• To evaluate patient and provider preferences/attitudes toward in-office versus virtual-
video postoperative visits 
 
C. RESEARCH PLAN 
 
Overall Study Design 
• 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. 
 
Outcome Measures 
• Primary Outcome:  
o Patient satisfaction as measured by the Patient Satisfaction Questionnaire-18 at 
the 6-week postoperative visit 
• Secondary Outcomes:  
o 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 after the scheduled postoperative visit up to 12 weeks 
following surgery 
o Adverse events after the scheduled postoperative visit up to 12 weeks following 
surgery 
o Patient and provider preferences/attitudes toward virtual or office visits  
 

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Eligibility Criteria 
• All 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 (Main Campus, Fairview Hospital, Hillcrest Hospital, Medina Hospital and 
Beachwood Ambulatory Surgery Center) scheduled to undergo major or minor surgery 
for pelvic organ prolapse and/or urinary incontinence  
o Major surgery+ 
 Minimally invasive (laparoscopic or robotic) sacrocolpopexy 
 Vaginal colpopexy (intraperitoneal or extraperitoneal) 
 Vaginal or minimally invasive (laparoscopic or robotic) hysteropexy (uterine 
suspension) 
 Obliterative procedures (colpocleisis) 
+ Additional procedures accompanying the above major operations may 
include: hysterectomy (total or supracervical), trachelectomy, salpingectomy or 
salpingo-oophorectomy, anterior and/or posterior colporrhaphy with 
perineorrhaphy, enterocele repair, minimally invasive Burch colposuspension 
or paravaginal defect repair, vaginal mesh removal or revision, placement of 
vaginal graft, or placement of mid-urethral sling  
o Minor surgery 
 Isolated colporrhaphy (anterior/posterior) and/or perineorrhaphy 
 Placement of mid-urethral sling 
 Vaginal mesh removal or revision 
• Inclusion Criteria 
o Age greater than 18 years old 
o Has technological capability to participate in videoconferencing (high-speed 
internet access with desktop computer or mobile device) 
o Has decision-making capacity and able to provide informed consent for research 
participation 
o Able to speak and read English 
• Exclusion Criteria  
o Patient requested to physically come in the office or have a virtual visit for her 
postoperative visit 
o Planned concomitant surgery with another surgical team 
o Office follow-up is deemed medically necessary by provider/surgeon 
 
Study Procedures 
• Screening and Recruitment 
o 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.  
o Compensation will be provided to trial participants with a total of $50 in the form of 
a check in the mail from Cleveland Clinic. The payment will be prorated according 
to the procedures completed. The participant will receive $10 after completion of 
the Patient Preparedness Questionnaire pre-operatively, $20 after completion of 
the Patient Satisfaction Questionnaire-18 postoperatively, and $20 after 
completion of the Patient Postoperative Visit Questionnaire postoperatively. 
Addresses for mailing of checks will be verified. 
o Reasons for declining participation in the study will be collected and recorded 
separately. 
 

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• Consent/Assent Process 
o Patients who agree to participate will sign a consent form. The consent interview 
will occur during the participant’s preoperative visit at the Center for 
Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic. 
Alternatively, the patient will be able to provide consent for research participation 
remotely via electronic signature using the DocuSign eConsent Platform.  
 
• Randomization:  
o Trial participants will be randomized to one of two arms:  
 1) Office Visit (Control Arm): Patients randomized to the control 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. 
 2) Virtual Visit (Intervention Arm): Patients randomized to the intervention 
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.  
o 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). The allocation sequence will be generated with block size of 4 
using computer software. Randomization will be implemented with the REDCap 
Randomization module. Randomization schedule can only be accessed by a 
research personnel not directly involved in patient care. The patient’s 6-week 
postoperative visit will be scheduled according to her assigned group. 
 
• Study instruments: 
o 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.   
o The PPQ will be administered during the preoperative visit to assess patient 
knowledge and preparedness for surgery, which has been demonstrated in other 
studies to impact postoperative satisfaction, perceived complications, and drug 
utilization.10-11 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 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). Although 
there are currently no validated measures to assess surgical preparedness in 
urogynecology, the PPQ has been used in several studies assessing surgical 
preparedness in women undergoing pelvic organ prolapse and/or stress urinary 
incontinence.8,12 These studies utilized the same cutoff score for question 11 (i.e., 
an answer of “strongly agree” to the question “overall, I feel prepared for my 
upcoming surgery”) to define meeting criteria for preoperative preparedness.  
o The PSQ-18 will be administered after the 6-week postoperative virtual or in-office 
visit to assess patient satisfaction with their postoperative visit. The PSQ-18 is a 

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validated 18-item questionnaire developed to evaluate satisfaction with medical 
care in seven domains, namely general satisfaction, technical quality, 
interpersonal manner, communication, financial aspects, time spent with doctor, 
and accessibility and convenience. Responses 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). The questionnaire has been studied extensively 
and used as a valid and reliable measure of satisfaction in a variety of settings, 
including postoperative care after pelvic organ prolapse surgery and minimally 
invasive gynecologic surgery.5-6 
o Currently, there are no validated tools to assess patient or provider attitudes 
towards telemedicine in urogynecology. A customized patient questionnaire 
“Patient Postoperative Visit Questionnaire” will be administered after the six-week 
postoperative visit to assess patient’s preference/attitude towards virtual and office 
visits. The items in this questionnaire were adapted from a survey used in a cross-
sectional study of patients and clinicians (psychiatry, neurology, cardiology, 
oncology, and primary care) participating in telehealth virtual video visits in an 
academic health system.3 The questionnaire was originally developed by the MGH 
Center for TeleHealth leadership and Mongan Institute Health Policy Center 
research team and consists of 7 comparative questions about office visits and 
virtual video visits. The customized survey 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.  
o A provider preference questionnaire “Provider Postoperative Visit Preference 
Questionnaire” will be administered to the surgeon or advanced practice provider 
after completion of the six-week postoperative visit to assess provider 
preference/attitudes. The questionnaire was adapted from the provider survey 
utilized by Donelan et al. and consists of 10 comparative questions about office 
visits and virtual video visits.3 
o All questionnaires can be completed either with paper forms or electronically 
through Research Electronic Data Capture (REDCap), depending on 
patient/provider preference. Study participants will be reminded within 48 to 72 
hours after their visit regarding completion of their questionnaires by telephone call 
using a standardized phone script or by text or email message after their 
preoperative visit and their 6-week postoperative visit. Reminders for survey 
completion will be sent up to two times. 
 
• Preoperative Visit 
o The preoperative visit will take place per our standard protocol, which includes a 
thorough discussion of the surgical purpose, alternatives, benefits, 
risks/complications, and postoperative expectations. Following informed consent, 
study-related procedures during the preoperative visit include study randomization, 
and scheduling of postoperative visits per study protocol. The PPQ will also be 
administered during this visit.  
 
• Postoperative Visit (6 weeks) 
o Prior to the 6-week postoperative visit, a study investigator will initiate a reminder 
to the participant by phone, email or text to remind her of her upcoming 
appointment using a standard script. A checklist of discussion points will be used 
to standardize counseling and evaluation during the 6-week postoperative visit. 
Both office and virtual visits will be conducted in the same manner: The provider 

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will inquire about any concerns the patient has regarding recovery, followed by any 
unanticipated healthcare encounters at outside facilities. These outside healthcare 
encounters will be documented by the provider in their Epic note to facilitate data 
collection by the study investigators. The provider will review key aspects of 
postoperative care (bowel function, urinary function, presence of vaginal bleeding, 
dietary status, and ambulatory status), postoperative instructions and precautions, 
findings and procedures done during surgery, and pathology results (if applicable). 
The provider will then visually examine surgical sites and document their findings 
in their Epic note. The provider will inquire about any additional questions from the 
patient and perform additional evaluation/treatments per standard of care. The 
PSQ-18 and the Patient Postoperative Visit questionnaire will be administered 
after this visit. The patient may be contacted for up to two times by a study 
investigator via phone, text or email within 48 to 72 hours after the visit regarding 
completion of study questionnaires using a script.  
 
• Provider Recruitment and Study Procedures 
o Surgeons and advanced practice providers will be educated about the study 
during the Urogynecology Section Research Meeting as part of the provider 
recruitment process. 
o After the six-week virtual or in-office visit, the provider will fill out the Provider 
Information Sheet and the Provider Postoperative Visit Preference Questionnaire. 
The provider will complete the questionnaire at the end of the visit. If this is not 
feasible, the provider will be sent a text reminder for up to two times to their 
Cleveland Clinic issued phone number within 48 to 72 hours after the visit.  
 
 

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Preoperative 
Visit 
Day of 
Surgery 
Postoperative 
Visit  
(6 weeks) 
End of study 
follow-up  
(12 weeks after 
surgery) 
Questionnaire: PPQ  
 
X 
 
 
 
Questionnaire:  
PSQ-18  
 
 
 
X 
 
Questionnaire:  
Patient Postoperative Visit   
 
 
 
X 
 
Questionnaire:  
Provider Postoperative Visit 
Preference  
 
 
 
X 
 
Data collection:  
Demographic and baseline 
clinical characteristics 
X 
 
 
 
Data collection:  
Perioperative characteristics 
 
X 
 
 
Data collection:  
Postoperative healthcare 
resource utilization, adverse 
events 
 
 
X 
X 
 

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D. DATA ANALYSIS PLAN 
 
• Data Collection 
 
o A) Demographic data will include the following: 
 Date of preoperative visit (MM/DD/YYYY) 
 Route of preoperative visit with surgeon (in-office/virtual) 
 MRN 
 Age (years) 
 Race 
 Ethnicity 
 Marital status 
 Distance from home to clinic (miles) 
 Vaginal parity 
 Menopausal state 
 Current tobacco use (Y/N) 
 BMI (kg/m2) 
 Comorbid conditions (MI, CHF, peripheral vascular disease, 
cerebrovascular disease, dementia, chronic pulmonary disease, connective 
tissue disease, ulcer disease, mild liver disease, diabetes, diabetes with 
end organ damage, hemiplegia, moderate or severe renal disease, any 
tumor without metastasis, leukemia, lymphoma, moderate or severe liver 
disease, metastatic solid tumor, AIDS) 
 Charlson Comorbidity Index (CCI) score 
• Calculation for CCI: diabetes with complications, 
hemiplegia/paraplegia, renal disease, and malignancies, age 60-69 
are assigned a score of 2; age 70-79 moderate/severe liver disease 
is assigned a score of 3; metastatic solid tumour and AIDS/HIV are 
assigned a score of 6; the remaining comorbidities are assigned a 
score of 1 
 Prior prolapse surgery (Y/N; if Y, specify) 
 Prior anti-incontinence surgery (Y/N; if Y, specify) 
 Preoperative prolapse overall stage based on POP-Q exam (0, I, II, III, IV) 
 Preoperative POP-Q points (Aa, Ba, C, GH, PB, TVL, Ap, Bp, D) 
 Preference for text or email reminder communication 
 Preferred mobile phone number or email address 
 
o B) Perioperative data will include the following: 
 Date of surgery (MM/DD/YYYY) 
 Location of OR facility 
 Surgery level (Minor, Major) 
 Surgery type 
 Concomitant procedures 
 Operative time (minutes) 
 Estimated blood loss (ml) 
 Intraoperative complications (bladder injury, ureteral kinking, bowel injury, 
vascular injury, EBL ≥300 ml, transfusion, conversion to open procedure, 
other-specify) 
 Hospital length of stay (no. of hours if <24 hours; no. of days if >24 hours) 
 If patient was admitted, was the admission planned (Y/N) 

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• If N, specify reason for postoperative admission 
 Voiding trial results (Pass/Fail) 
• If Fail, select outcome: foley catheter reinserted, patient taught 
intermittent self-catheterization 
 Postoperative prescriptions at discharge (name, dosing, quantity)  
 
o C) Six-week postoperative data will include the following: 
 Date of postoperative visit (MM/DD/YYYY) 
 Number of days postop at 6-week visit 
 Route of postoperative visit (in-office, virtual) 
• If virtual, was an in-office visit recommended for further evaluation 
(Y/N); reason for office evaluation (specify) 
• If virtual, did the patient require assistance with using video 
conference technology prior to their scheduled appointment (Y/N) 
• If virtual, were there any technological difficulties during the visit 
(Y/N) 
 Did the patient cross-over to the other group at any point before the 6-week 
visit (Y/N)? 
 Provider conducting postoperative visit (APRN, MD, other-specify) 
 Abdominal exam performed (Y/N); if Y, list findings (normal, abnormal-
specify) 
 Pelvic/vaginal exam performed (Y/N); if Y, list findings (normal, abnormal-
specify) 
 Patient-initiated phone call to surgeon’s office prior to 6-week postoperative 
visit (Y/N); if Y, 
• Total number of phone calls (No. of occurrences) 
• Date of phone call #1 (MM/DD/YYYY) 
o Reason/s for phone call #1 
o Outcome of phone call (counseling/reassurance, prescription 
sent, new order placed, new office/virtual appointment 
scheduled, advised to go to ED/urgent care, provider placed 
follow-up call to patient the next day, other-specify) 
• Date of phone call #2 (MM/DD/YYYY) 
o Reason/s for phone call #2 
o Outcome of phone call 
• Date of phone call #3 (MM/DD/YYYY) 
o Reason/s for phone call #3 
o Outcome of phone call 
 Unanticipated outpatient (office/virtual) visits to surgeon’s office prior to 6-
week postoperative visit (Y/N); if Y, 
• Total number of outpatient visits including office voiding trials (No. of 
occurrences) 
• Total number of voiding trial visits (No. of occurrences) 
• Date of outpatient visit #1 (MM/DD/YYYY) 
o Reason/s for outpatient visit 
o Outcome of outpatient visit (counseling/reassurance, 
prescription sent, new order placed, new office/virtual 
appointment scheduled, advised to go to ED/urgent care, 
hospital/direct admission, reoperation, provider/patient to 
place follow-up call, other-specify) 

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• Date of outpatient visit #2 (MM/DD/YYYY) 
o Reason/s for outpatient visit 
o Outcome of outpatient visit 
• Date of outpatient visit #3 (MM/DD/YYYY) 
o Reason/s for outpatient visit 
o Outcome of outpatient visit 
 Emergency department or urgent care visits prior to 6-week postoperative 
visit (Y/N); if Y, 
• Total number of ED/urgent care visits (No. of occurrences) 
• Date of ED visit #1 (MM/DD/YYYY) 
o Reason/s for ED visit 
o Outcome of ED visit (discharge, readmission, reoperation, 
other-specify) 
• Date of ED visit #2 (MM/DD/YYYY) 
o Reason/s for ED visit 
o Outcome of ED visit (discharge, readmission, reoperation, 
other-specify) 
 Hospital readmissions prior to 6-week postoperative visit (Y/N); if Y, 
• Total number of hospital readmissions 
• Date of readmission #1 
o Reason/s for readmission 
o Outcome of readmission (discharge, reoperation, other-
specify) 
o Hospital length of stay (no. of days) 
 Adverse events prior to postoperative visit (Y/N); if Y, specify (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) 
 
o D) Twelve-week postoperative data will include the following: 
 End of follow-up (i.e., date marking 6 weeks after the patient’s scheduled 6-
week postoperative visit) (MM/DD/YYYY) 
 Number of days postop at date above 
 Patient-initiated phone call to surgeon’s office during the next six weeks 
following the scheduled 6-week postoperative visit (Y/N); if Y, 
• Total number of phone calls (No. of occurrences) 
• Date of phone call #1 (MM/DD/YYYY) 
o Reason/s for phone call #1 
o Outcome of phone call (counseling/reassurance, prescription 
sent, new order placed, new office/virtual appointment 
scheduled, advised to go to ED/urgent care, provider placed 
follow-up call to patient the next day, other-specify) 
• Date of phone call #2 (MM/DD/YYYY) 
o Reason/s for phone call #2 
o Outcome of phone call 

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 Unanticipated outpatient (office/virtual) visits to surgeon’s office during the 
next six weeks following the scheduled 6-week postoperative visit (Y/N); if 
Y, 
• Total number of outpatient visits including office voiding trials (No. of 
occurrences) 
• Total number of voiding trial visits (No. of occurrences) 
• Date of outpatient visit #1 (MM/DD/YYYY) 
o Reason/s for outpatient visit 
o Outcome of outpatient visit (counseling/reassurance, 
prescription sent, new order placed, new office/virtual 
appointment scheduled, advised to go to ED/urgent care, 
hospital/direct admission, reoperation, provider/patient to 
place follow-up call, other-specify) 
• Date of outpatient visit #2 (MM/DD/YYYY) 
o Reason/s for outpatient visit 
o Outcome of outpatient visit 
 Emergency department or urgent care visits during the next six weeks 
following the scheduled 6-week postoperative visit (Y/N); if Y, 
• Total number of ED/urgent care visits (No. of occurrences) 
• Date of ED visit #1 (MM/DD/YYYY) 
o Reason/s for ED visit 
o Outcome of ED visit (discharge, readmission, reoperation, 
other-specify) 
• Date of ED visit #2 (MM/DD/YYYY) 
o Reason/s for ED visit 
o Outcome of ED visit (discharge, readmission, reoperation, 
other-specify) 
 Hospital readmissions during the next six weeks following the scheduled 6-
week postoperative visit (Y/N); if Y, 
• Total number of hospital readmissions 
• Date of readmission #1 
o Reason/s for readmission 
o Outcome of readmission (discharge, reoperation, other-
specify) 
o Hospital length of stay (no. of days) 
 Adverse events during the next six weeks following the scheduled 6-week 
postoperative visit (Y/N); if Y, specify (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) 
 
• Power Analysis and Sample Size Calculation 
o The primary outcome of this study is to compare patient satisfaction between 
patients scheduled for office versus virtual six-week postoperative visits.  
o 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 

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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.6,13 To account for an 
anticipated attrition rate of approximately 5%, we aimed to enroll a total of 106 
participants (53 per group).  
 
• Statistical Analysis 
o 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. 
o 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.  
o All statistical analyses will be performed using JMP Pro version 17.0 software 
(SAS Institute, Cary, NC). 
o Data will be managed in REDCap. Statistical support will be provided by the 
Cleveland Clinic Quantitative Health Sciences. 
 
E. PRIVACY AND CONFIDENTIALITY 
 
Protection of each subject’s personal health information will be a priority in this study. One 
master Excel file containing subject personal information including name and medical record 
number will be kept in a password-protected file, on a designated protected research drive 
on a password-protected computer in a locked office at the Cleveland Clinic. In that file, each 
subject will be assigned a subject identification number that will be used for the purposes of 
data collection in order to de-identify subjects. All paper forms used for data collection will be 
kept in a research cabinet dedicated to this project which will be locked at all times, in a 

v.2.8.2024 
                 Page 14 of 15 
locked office at the Cleveland Clinic. All forms will contain de-identified information; 
identification numbers will correspond to the subjects listed in the master Excel file. All study 
data will be transferred and managed electronically using REDCap. Each subject will be 
entered into REDCap using the assigned identification number from the master Excel file. 
 
F. DATA/SAMPLE SHARING 
 
Not applicable 
 
G. ADVERSE EVENTS AND DATA MONITORING 
 
Any adverse event or unanticipated events will be reported as soon as feasible to the IRB 
using IRB WebKit. Examples of adverse events include inability to attend the postoperative 
visit due to technological issues (If the visit cannot be completed due to technological issues, 
the provider will ensure that the appointment is rescheduled to another time that is 
convenient and acceptable to the patient). All events will be recorded and kept in a research 
binder assigned to this study in a locked office. Monthly reviews during the study period will 
be done by all involved study staff members to ensure that events are not occurring, and if 
they are, that they are being handled and reported properly. The study will be terminated if 
patients in the intervention arm have decreased satisfaction of 20% compared to the control 
arm. This will be assessed monthly at the reviews mentioned above. 
 
H. STUDY TIMELINE 
 
The goal for this research study is for completion by the conclusion of the primary 
investigator’s (LLL) three-year fellowship at Cleveland Clinic (June 2024). After obtaining 
institutional review board approval, a discussion will be held at the section research meeting 
to educate all urogynecology staff, fellows, and nurse practitioners on the implementation of 
this project. An in-service will be given to familiarize outpatient nursing staff and scheduling 
staff with the project.  
 
Patient recruitment will begin thereafter with the goal of recruiting and completing data 
collection on all patients over an 18-month time period. At the end of this time, final data 
analysis will be performed and manuscript preparation will be initiated. The manuscript will 
be submitted to a high impact gynecology journal. This timeline ensures project completion 
well before the conclusion of the primary investigator’s fellowship. 
 
 
 
 
 
 

v.2.8.2024 
                 Page 15 of 15 
I. REFERENCES 
 
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