Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04855708
Status:
TERMINATED
Last Update Posted:
2023-06-27
First Post:
2021-02-17
Brief Title:
Patient Satisfaction With Virtual Visits
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Evaluating Patient Satisfaction With 2-week Post-operative Virtual Visits Compared to In-office Visits A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not pursued
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 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 The investigators 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 the postoperative visit experience as measured by the Press Ganey Medical Practice Survey and Medical Practice Telemedicine Survey The secondary objectives include evaluating the incidence of a new diagnosis of a postoperative complication requiring medical treatment eg 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 and bloodstream thromboembolic events bleeding and issues with wound healing such as dehiscence The investigators will record no-show rates visit times and estimated travel distance as measured by distance of home to clinic site
Detailed Description:
This is a two arm randomized non-inferiority clinical trial that will take place within the Minimally Invasive Gynecologic Surgery division in the Womens Health Institute of the Cleveland Clinic Cleveland OH
Population - The Investigators 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
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 11 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 are currently sent to all patients by the Office of Patient Experience at our institution four days after their postoperative appointment The investigators will provide verbal reminders about study participation and survey administration at the visit Survey data will be obtained through the Office of Patient Experience and imported into RedCap The secondary outcome is a new diagnosis of a postoperative complication requiring medical treatment eg 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 and bloodstream thromboembolic events bleeding and issues with wound healing such as dehiscence Calvien-Dindo classification system for postoperative complications will be used The Investigators will also look at no-show rates visit times and travel distance
The investigators will collect basic demographic information from the EMR including age BMI parity and prior surgical history Surgical indication procedure performed length of hospital stay and perioperative outcomes reoperation readmission unscheduled office or virtual visits ie earlier than the scheduled 2 week visit EDurgent care visits infection rates will also be obtained No-show rates will be obtained through the EMR The investigators will also note if a planned virtual visit is unable to be completed due to technical difficulties or is converted to a telephone visit Travel distance from home to clinic site will be calculated using average travel time with minimal traffic based on participants zip code using Google Maps
The investigators 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
The Investigators 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 Sample size of 70 patients in each arm is needed to achieve 90 power to detect a non-inferiority margin of -020 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 Pearsons chi-square tests or Fishers exact tests
All analyses will be done using SAS version 94 The SAS Institute Cary NC and a p 005 will be considered statistically significant
Study Timeline
The MIGS division performs at least 20-30 hysterectomies per month The Investigators estimate to achieve our target recruitment in 7-8 months
Population - The Investigators 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
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 11 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 are currently sent to all patients by the Office of Patient Experience at our institution four days after their postoperative appointment The investigators will provide verbal reminders about study participation and survey administration at the visit Survey data will be obtained through the Office of Patient Experience and imported into RedCap The secondary outcome is a new diagnosis of a postoperative complication requiring medical treatment eg 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 and bloodstream thromboembolic events bleeding and issues with wound healing such as dehiscence Calvien-Dindo classification system for postoperative complications will be used The Investigators will also look at no-show rates visit times and travel distance
The investigators will collect basic demographic information from the EMR including age BMI parity and prior surgical history Surgical indication procedure performed length of hospital stay and perioperative outcomes reoperation readmission unscheduled office or virtual visits ie earlier than the scheduled 2 week visit EDurgent care visits infection rates will also be obtained No-show rates will be obtained through the EMR The investigators will also note if a planned virtual visit is unable to be completed due to technical difficulties or is converted to a telephone visit Travel distance from home to clinic site will be calculated using average travel time with minimal traffic based on participants zip code using Google Maps
The investigators 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
The Investigators 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 Sample size of 70 patients in each arm is needed to achieve 90 power to detect a non-inferiority margin of -020 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 Pearsons chi-square tests or Fishers exact tests
All analyses will be done using SAS version 94 The SAS Institute Cary NC and a p 005 will be considered statistically significant
Study Timeline
The MIGS division performs at least 20-30 hysterectomies per month The Investigators estimate to achieve our target recruitment in 7-8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None