Evaluating Patient Satisfaction With 2-week Post-operative Virtual Visits Compared to In-office Visits: A Randomized Controlled Trial
Phase: NA
Conditions: Satisfaction, Patient
Sponsor: The Cleveland Clinic

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Evaluating patient satisfaction with 2-week post-operative virtual visits compared to in-
office visits: A randomized control trial. 
 
Principal Investigators: 
Rosanne M Kho MD 
 
 
 
 
Catherine Keller MD 
 
 
 
 
Meng Yao 
 
Cara King DO, Lindsey Valentine MD, Miguel Luna MD, Jean Uy-Kroh MD, Megan Orlando MD, 
Angelina Carey-Love MD, Lindsay Haibach CNP, Kelsey Kennedy CNP, Erin Reaper CNP 
 
Background 
Telemedicine is defined as “the use of computer-based technologies to manage a patient’s 
health by exchanging medical information over a distance”. (Harting, et al).  As technologies like 
smartphones, tablets, and computers have become more integrated into everyday life, they 
have also been incorporated into medical practice. Telephone visits have been incorporated into 
a variety of surgical fields, including pediatric surgery, urology, and outpatient general surgery 
(Young, et al; Finklestein, et al; Soegaard Ballester, et al) and are associated with decreased 
overall visit times and shortened or eliminated travel times (Soegaard Ballester, et al.).  
Virtual visits (visits conducted face-to-face using computers, tablets, or smartphones) have 
grown in popularity.  A systematic review noted that the concerns of physicians conducting 
telephone-based care included potential risk of missing a serious condition, inability to use 
visual cues, and inability to conduct a physical exam. (Car, et al.) Virtual visits add back a visual 
component of an in-person visit, while preserving the above benefits of telephone visits. In the 
General Surgery literature, patients attending virtual visits after outpatient surgery reported 
higher levels of satisfaction than their in-person counterparts. (Healy, et al.) 
Telemedicine has been introduced in obstetrics for prenatal care, monitoring of chronic 
conditions during pregnancy, genetic counseling, medical abortion, and colposcopy (Kohn, et 
al., Griener). A randomized control trial in urogynecology in 2019 demonstrated that telephone-
based postoperative visits were non-inferior to in-person postoperative visits in terms of patient 
satisfaction. (Thompson, et al.)  Although utilization of telemedicine in OB/GYN is expanding, 
there is still a dearth of literature, particularly regarding virtual visits in gynecology. The 
Cleveland Clinic has instituted telemedicine with the provision of virtual visits in all specialties. In 
benign gynecologic surgery, virtual visits have been offered in the last couple of years as an 
alternative to the in-person 2-week post-operative visit, but have not been evaluated 
systematically.   
Our study aims to evaluate the safety and efficacy of virtual postoperative visits as compared to 
in-office postoperative visits for patients undergoing minimally invasive hysterectomy. We 
hypothesize that virtual visits will be non-inferior to in-person visits in terms of patient 
satisfaction. The primary objective for this study is to evaluate patient satisfaction of their 
postoperative visit experience, as measured by the Press Ganey Medical Practice Survey and 
Medical Practice Telemedicine Survey (Presson, et al). The secondary objectives include 
evaluating the incidence of a new diagnosis of a postoperative complication requiring medical 
treatment (e.g. calling in of a prescription), an office visit with CNP or MIGS surgeon, or an 
urgent care or ER visit. Post-operative complications include infection (urinary, pulmonary, 
wound, pelvic abscess, bloodstream), thromboembolic events, bleeding; and issues with wound 
healing, such as dehiscence. We will record no-show rates, visit times, and estimated travel 
distance as measured by distance of home to clinic site (Srikrishna, et al).   
 
Study Methods:  
  

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This is a two arm, randomized non-inferiority clinical trial.  
  
Setting 
         This study will take place within the Minimally Invasive Gynecologic Surgery division in 
the Women’s Health Institute of the Cleveland Clinic, Cleveland, OH.  
  
Population 
         We will recruit patients undergoing benign minimally invasive hysterectomy 
(laparoscopic, robotic, and vaginal). Inclusion criteria include patients >18 years of age who are 
able to provide informed consent without assistance, speak English, and who have access to a 
phone or device equipped for virtual visits. Patients will be excluded if the staff surgeon 
determines they are inappropriate for virtual follow-up, if there is suspicion of malignancy, if they 
are unable to provide consent, or if they do not have access to technology that enables virtual 
visits.   
 
Inclusion criteria 
Exclusion criteria 
>18 years of age 
Deemed ineligible by staff surgeon 
Able to provide consent without 
assistance 
Suspicion of malignancy 
English-speaking 
Unable to provide consent 
Access to phone or device equipped for 
virtual visits 
Do not have access to technology for 
virtual visits 
 
  
Recruitment 
Enrolled participants will be randomized to either a two-week virtual postoperative visit 
with a certified nurse practitioner (CNP) or a two-week in-office postoperative visit with a 
certified nurse practitioner (CNP) in a 1:1 allocation ratio. Block randomizations with block size 
of 4 will be assigned to nurse providers independently. Randomization schedules will be 
implemented by Redcap. 
  
Data collection 
The primary outcome of this study is patient satisfaction, as measured by the Press 
Ganey Medical Practice Survey and Medical Practice Telemedicine Survey. These 
questionnaires will be sent via RedCap on the day of their two-week postoperative appointment.  
We will provide verbal reminders about study participation and survey administration at the visit. 
If participants have not responded by their six-week visit, a scripted phone call will be made as a 
reminder. The secondary outcome is a new diagnosis of a postoperative complication requiring 
medical treatment (e.g. calling in of a prescription), an office visit with a CNP or MIGS surgeon, 
or an urgent care or ER visit. Complications include infection (urinary, pulmonary, wound, pelvic 
abscess, bloodstream); thromboembolic events; bleeding; and issues with wound healing, such 
as dehiscence. Calvien-Dindo classification system for postoperative complications will be used. 
We will also look at no-show rates, visit times, and travel distance. 
            We will collect basic demographic information from the EMR, including MRN, age, email 
address, BMI, race, insurance status, parity, and prior surgical history.  Date of enrollment, date 
of surgery, date of admission, and date of discharge will be recorded. Surgical indication, 
procedure performed, length of hospital stay, and perioperative outcomes (reoperation, 
readmission, unscheduled office or virtual visits (i.e. earlier than the scheduled 2 week visit), 
ED/urgent care visits, infection rates) will also be obtained. No-show rates will be obtained 
through the EMR. We will also note if a planned virtual visit is unable to be completed due to 

v.11.21.2021 
 
technical difficulties, or is converted to a telephone visit.  We will collect date of their 6 week 
postoperative visit or date they withdrew from the study. We will collect zip code; travel distance 
from home to clinic site will be calculated using average travel time with minimal traffic based on 
participant’s zip code using Google Maps. 
            We will collect the reason for ineligibility for all patients deemed such by staff surgeons.  
            All participants will be assigned a study number to facilitate de-identification of data. 
Data will be compiled in RedCap and securely stored on an encrypted server.  
 
  
Statistical analysis 
Power Calculation: 
We hypothesized that patient satisfaction would be non-inferior for patients randomized 
to the postoperative virtual visit compared to those randomized to in-person virtual visit 
(Thompson, et al). Sample size of 70 patients in each arm is needed to achieve 90% power to 
detect a non-inferiority margin of -0.20. Allowing for a dropout rate of 20%, 88 patients will be 
recruited in each arm.  
 
Analysis plan: 
For the primary outcome, the Farrington-Manning score test for non-inferiority will be 
performed, for both intention-to-treat and per-protocol analyses. 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 done using SAS (version 9.4, The SAS Institute, Cary, NC) and a p < 
0.05 will be considered statistically significant. 
 
Study Timeline:  
The MIGS division performs at least 20-30 hysterectomies per month.  We estimate to 
achieve our target recruitment in 7-8 months.   
 
References 
Harting M; Wheeler A; Ponsky T; Nwomeh B; Snyder C; Bruns N; Lesher A; Pandya S; Dickie 
B; Shah S. Telemedicine in pediatric surgery. Journal of Pediatric Surgery 2019 vol: 54 (3) pp 
587-594. 
Young K; Gupta A; Palacios R. Impact of Telemedicine in Pediatric Postoperative Care. 
TELEMEDICINE and e-HEALTH. 25 (12). 
  
Finkelstein J; Cahill D; Kurtz M; Campbell J; Schumann C; Varda B; Grant R; Humphrey K; 
Meyers H; Nelson C; Estrada C. The Use of Telemedicine for the Postoperative Urological Care 
of Children: Results of a Pilot Program. Journal of Urology. 202 (1) 159-163. 2019. 
  
Soegaard Ballester J; Scott M; Owei L; Neylan C; Hanson C; Morris J. Patient preference for 
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Car J; Sheikh A. Telephone Consultations. BMJ. 326, 966 - 969. May 2003.  
  
Healy, et al. Virtual outpatient clinic as an alternative to an actual clinic visit after surgical 
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Provided Through Telemedicine in Four U.S. States. Obstetrics & Gynecology 
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Griener A. Telemedicine Applications in Obstetrics and Gynecology. Clinical Obstetrics and 
Gynecology. 2017 vol: 60 (4) pp853-866. 
 
Thomson J, et al. Outpatient visits versus telephone interviews for postoperative care: a 
randomized controlled trial. International Urogynecology Journal. 2019 vol: 30 pp1639-1646. 
  
Presson, A.P., Zhang, C., Abtahi, A.M. et al. Psychometric properties of the Press Ganey® 
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Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial. Female 
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v.11.21.2021 
 
 
 
 
Evaluating patient satisfaction with 2-week post-operative virtual visits compared 
to in-office visits: a randomized control trial. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FMIGS Fellows: Megan Orlando, Angelina Carey-Love 
MIGS Surgeons: Rosanne Kho, Cara King, Lindsey Valentine, Jean Uy-Kroh, Miguel 
Luna-Russo,  
MIGS NPs: Kelsey Kennedy, Erin Reaper, Lindsay Haibach 
Study coordinator: Catherine Keller  
Potential study candidate identified at pre-op 
visit: 
• Discuss study 
• Provide consent form 
 
• Patient will be randomized by MIGS 
surgeon/fellows/NP 
• Staff message Catherine Keller/MIGS 
NP with randomization group 
• Place 2 week postoperative visit order 
at this time 
Virtual visit group 
In-person group 
Surgery 
• Survey administration via RedCap 
• 6 week in person postoperative visit