Clinical trial NCT04348357: Utilizing Telemedicine for Delivery of Postoperative Care
Official title: Utilizing Telemedicine for Delivery of Postoperative Care Following Minimally-invasive Gynecologic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Gynecologic Surgery
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose a pilot project in which enrolled patients undergoing major gynecologic surgery will be randomized to either a traditional office postoperative visit or a telemedicine postoperative visit. The two groups will then be compared on a variety of metrics including clinical outcomes, patient satisfaction and time.

Detailed description: Project title: Utilizing telemedicine for delivery of postoperative care following minimally-invasive gynecologic surgery: A randomized controlled trial

Principal Investigator: Steven Radtke MD FACOG Co-Investigators: Randle Umeh MD Research Associate: Martha Chavez, MPA Biostatistician: Zuber Mulla, Ph.D., Professor Affiliations: Texas Tech University Health Science Center El Paso, Paul L. Foster School of Medicine

Background:

The wide-spread use of minimally invasive techniques in gynecologic surgery has brought several tangible benefits to patients including faster-recovery times, shorter hospital stays, decreased risk of long term complications, to name a few. 1-3 Technological advances such as the development of robotic assistance have allowed to further expand the number of cases that can be performed via a minimally invasive approach.4 The shift has been such that the landscape regarding operative routes in gynecologic surgery has completely reversed, with now the majority of cases being performed laparoscopically. 5 Although much has changed intraoperatively, the surrounding structure of an operative has lagged. Specifically, preoperative and post-operative visits are still conducted in a similar way than how it was done 20 years ago. Despite leaps in technology, the field of gynecologic surgery has been slow to widely implement these advances into perioperative practice. One of the specific areas of opportunity is the postoperative visit. It is common practice in the majority of fields to have a visit with the patient approximately 2 weeks after surgery. The objective of this visit is to evaluate how the patient has been progressing, examine the wound site(s), and discuss pathology results from any specimens that were removed during the procedure.

The logistics of this visit involve blocking a time-slot in an established clinic day. The patient is required to transport herself to the clinic site. Once checked-in, there may be a waiting period before being placed in a room for the practitioner to conduct the visit. Once the visit is started, as long as there are no issues, the duration of the interaction may range on average between 3-7 minutes.

Despite these visits being short and usually straight-forward, the invested time that patients have to dedicate is substantially greater than the actual interaction with the clinician. Furthermore, because of the advantages of minimally invasive surgery, many patients have already returned to work by the time of the postoperative visit which may result in a disruption of their daily work schedule.

The ubiquitousness of high-speed internet and mobile phones have allowed for the field of telemedicine to thrive in recent years.6,7 Although wide-spread application of this modality has not been implemented in the field of gynecologic surgery, other areas such as urology and pediatrics have successfully implemented telemedicine programs, specifically for postoperative patients, yielding promising results. 8,9 The investigators propose a pilot project in which enrolled patients undergoing major gynecologic surgery will be randomized to either a traditional office postoperative visit or a telemedicine postoperative visit. The two groups will then be compared on a variety of metrics including clinical outcomes, patient satisfaction and time.

Objectives

1. Determine if there are differences in patient satisfaction between traditional postoperative visits and telemedicine postoperative visits
2. Determine the difference in time invested from the patient's side and clinicians side in order to complete the postoperative visit interaction
3. Analyze if there is a difference between groups regarding visits to the emergency department related to the surgery, delayed postoperative complications, etc.

Hypothesis Patient satisfaction will be greater in the telemedicine group. The total time invested will be decreased. There will be no difference in visits to the emergency department or unrecognized postoperative complications

Eligibility criteria: Inclusion criteria

* Female patients between ages 18-60
* Have access to smart-phone with video/audio and internet capabilities
* Undergoing laparoscopic gynecologic surgery that requires a postoperative visit
* Total laparoscopic hysterectomy
* Laparoscopic removal of adnexal structures
* Laparoscopic excision of endometriosis

Exclusion criteria

* Patient unwilling to participate
* The patient is unwilling to install and utilize the telemedicine app on their smartphone.

Primary outcomes:
measure: PSQ-18 General Satisfaction
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: PSQ-18 Technical Quality
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: PSQ-18 Interpersonal Manner
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: PSQ-18 Communication
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: PSQ-18 Time Spent With Doctor
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: PSQ-18 Accessibility and Convenience
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
Secondary outcomes:
measure: Actual Visit Time
timeFrame: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery
measure: Visits to Emergency Department
timeFrame: 30 days after surgery
measure: Phone-calls to Office
timeFrame: 30 days after surgery
measure: Time Dedicated by Patient to Complete Visit
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
measure: Number of Patients Who Desired to Switch Groups
timeFrame: 1 month after surgery (1-2 weeks after postoperative visit)
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Scince Center El Paso
state: Texas
Study officials:
affiliation: TTUHSCEP
name: Steven Radtke, MD
role: PRINCIPAL_INVESTIGATOR
References: