Satisfaction, PatientNCT04855708
Patient Satisfaction With Virtual Visits
A study testing Virtual visit and Office visit in people with Satisfaction, Patient, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Satisfaction, Patient
- What is being tested?
- Virtual visit and Office visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18
- Able to provide informed consent without assistance
- English speaking
- Access to phone or device equipped for virtual visit
Who cannot join
- Surgeon determines participant is not a good candidate for virtual follow-up visit
- Suspicion of malignancy
- Unable to provide informed consent
- No access to technology for virtual visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Patient Satisfaction With 2-week Post-operative Virtual Visits Compared to In-office Visits: A Randomized Controlled Trial
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 (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, 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.
Read the 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 Women's 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 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 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 (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, 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 (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. 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 participant's 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 -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. The Investigators estimate to achieve our target recruitment in 7-8 months.
- Conditions
- Satisfaction, Patient
- Being tested
- Virtual visit, Office visit
- Keywords
- Gynecology, Virtual visit, Post-operative, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual visitOther
Patients randomized to this group will have a virtual 2-week post-operative visit
Office visitOther
Patients randomized to this group will have a in-person 2-week post-operative visit
| Study group | Role | What they receive |
|---|---|---|
| Virtual visit | Experimental | Patients will have 2-week post-operative virtual visit Receives: Other: Virtual visit |
| Office visit | Active comparator | Patients will return to the office for a 2-week post-operative visit Receives: Other: Office visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction at 2-weeks
The Press Ganey Medical Practice Survey is used to provide feedback on improving aspects of the clinic experience. It measures access, moving through the visit, nurse/assistant, care provider, personal issues and overall assessment. The scale exists from 1-5 (1=very poor, 5=very good)
Measured: 2-weeks
Patient satisfaction at 2-weeks
The Press Ganey Medical Practice Telemedicine Survey is used to provide feedback on utilizing remote delivery of healthcare services. It measures access, care provider, telemedicine technology and overall access. The scale exists from 1-5 (1=very poor, 5=very good)
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start5 Feb 2021
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Why it stopped: Not pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsey Valentine, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855708
- Sponsor's protocol ID
- 21-141
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Satisfaction With 2-week Post-operative Virtual Visits Compared to In-office Visits: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04855708
- Acronym / sponsor ID
- 21-141
- Conditions
- Satisfaction, Patient
- Keywords
- Gynecology, Virtual visit, Post-operative, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not pursued
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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, 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 Women's 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 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 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 (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, 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 (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. 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 participant's 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 -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. The Investigators estimate to achieve our target recruitment in 7-8 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual visit | Experimental | Other: Virtual visitPatients will have 2-week post-operative virtual visit |
| Office visit | Active comparator | Other: Office visitPatients will return to the office for a 2-week post-operative visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18
- Able to provide informed consent without assistance
- English speaking
- Access to phone or device equipped for virtual visit
Key exclusion criteria (4 listed)
- Surgeon determines participant is not a good candidate for virtual follow-up visit
- Suspicion of malignancy
- Unable to provide informed consent
- No access to technology for virtual visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual visitPatients randomized to this group will have a virtual 2-week post-operative visit | Other | Virtual visit |
| Office visitPatients randomized to this group will have a in-person 2-week post-operative visit | Other | Office visit |
Primary outcome
Patient satisfaction at 2-weeks
Time frame: 2-weeks
The Press Ganey Medical Practice Survey is used to provide feedback on improving aspects of the clinic experience. It measures access, moving through the visit, nurse/assistant, care provider, personal issues and overall assessment. The scale exists from 1-5 (1=very poor, 5=very good)
Patient satisfaction at 2-weeks
Time frame: 2-weeks
The Press Ganey Medical Practice Telemedicine Survey is used to provide feedback on utilizing remote delivery of healthcare services. It measures access, care provider, telemedicine technology and overall access. The scale exists from 1-5 (1=very poor, 5=very good)
Results and safety
The study was stopped early (reason given: Not pursued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Valentine, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual visit and Office visit in people with Satisfaction, Patient, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not pursued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction at 2-weeks (time frame: 2-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.