- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420114
Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery (Telehealth RCT)
Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery: A Randomized Controlled 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Josef Jackson, MD
- Phone Number: 773-834-0598
- Email: josef.jackson@uchicagomedicine.org
Study Contact Backup
- Name: Sumeyra Agambayev, MS
- Email: sumeyra.agambayev@bsd.uchicago.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Contact:
- Sumeyra Agambayev, MS
- Phone Number: 773-834-9425
- Email: sagambay@uchicago.edu
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Hinsdale, Illinois, United States, 60521
- UChicago Medicine Advent Hinsdale
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Principal Investigator:
- Laura Douglass, MD
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Contact:
- Josef Jackson, MD
- Phone Number: 773-834-0598
- Email: josef.jackson@uchicagomedicine.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- Undergoing minimally invasive gynecologic surgeries with complex pelvic surgeons (AAGL fellowship-trained).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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control group
in person clinic visits
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experimental group
virtual visits ((telephone or video)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with surgery and postoperative visits
Time Frame: 3 months
|
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.
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3 months
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Patient satisfaction with virtual care delivery
Time Frame: 3 months
|
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).
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Additional healthcare utilization and adverse events
Time Frame: 3 months
|
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.
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3 months
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Incidence of common postoperative outcomes
Time Frame: 3 months
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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.
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3 months
|
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Postoperative pain
Time Frame: 3 months
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Pain scores will be tabulated using the Short-form McGill Pain Questionnaire 2
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Douglass, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB25-1847
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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