Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Chicago
About this trial
Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients.
Previous scholarship has demonstrated that telemedicine can be a safe alternative to face-to-face postoperative visits for surgical patients, streamlining recovery with no significant delays in the diagnosis of surgical complications. As healthcare systems continue to emphasize value-based care, it is important to assess whether virtual postoperative visits effectively meet patient needs while optimizing resource utilization.
Patient-reported outcomes and satisfaction surveys can help identify potential gaps in care and ensure that telehealth is implemented in a way to maximize both efficiency and quality. Our primary objective is to determine whether patient satisfaction with postoperative telehealth follow-up is non-inferior to in-person clinic visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has provided written informed consent.
Women over the age of 18.
Ability for patients to complete telehealth visits (i.e. working telephone or internet access) and speak and understand English.
Laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, and hysterectomy.
Disqualifiers
Conversion to open surgery.
Malignancy noted intraoperatively or on final pathology evaluation.
Surgeon or patient preference for in person clinic follow up.
Pregnancy - pregnancy tests will be completed as part of routine preoperative care on the day of surgery
Trial population
Women over the age of 18 and scheduled for a minimally invasive gynecologic surgery (laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, or hysterectomy.)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: control group
Group B: experimental group
Trial outcomes
Primary outcomes
1
Patient satisfaction with surgery and postoperative visits
Satisfaction scores will be compiled from participant responses to the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire. This questionnaire was developed by the American College of Surgeons and includes seven composites: (1) information to help prepare for surgery, (2) surgeon communication preoperatively, (3) surgeon attentiveness on the day of surgery, (4) information to help during recovery, (5) surgeon communication after surgery, (6) qualities of office staff, and (7) an overall surgeon rating. Specific attention will be paid to participant ratings of items 4, 5, and 7.
Time frame
3 months2
Patient satisfaction with virtual care delivery
Satisfaction scores will be compiled from responses to the Telehealth Usability Questionnaire (TUQ): a validated tool of 21 questions used to assess patients' and providers' perceptions of telehealth systems. It evaluates domains such as ease of use, interface quality, interaction quality, reliability, and overall satisfaction, providing a structured way to measure and improve telehealth user experience (graded on a 5-point Likert scale).
Time frame
3 monthsSecondary outcomes
1
Additional healthcare utilization and adverse events
Patient safety will be gauged by proxy via measurement of additional healthcare utilization by participants during the follow-up interval; specifically, the number of hospital re-admissions, emergency department or urgent care visits, and unscheduled clinic visits. Additionally, incidence of reoperation, blood transfusion, and wound infections will be tracked.
Time frame
3 months2
Incidence of common postoperative outcomes
Clinical outcomes will be evaluated by a standardized institutional postoperative questionnaire which queries patients about common postoperative symptoms including return of bowel function, return of appetite, use of additional pain medications, fevers, and vaginal bleeding.
Time frame
3 months3
Postoperative pain
Pain scores will be tabulated using the Short-form McGill Pain Questionnaire 2
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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