Utilizing Telemedicine for Delivery of Postoperative Care

Laparoscopic Gynecologic Surgery Clinical Trial

— Telemedicine  

Official title:

Utilizing Telemedicine for Delivery of Postoperative Care Following Minimally-invasive Gynecologic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348357
• Other study ID #: E19110
• Status: Completed
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: May 6, 2020

Study information

• Verified date: June 2020
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Gynecologic Surgery

Intervention

Other:
• Telemedicine
A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
• Office visit
Patient comes to the office to receive routine postoperative care

Locations

Country	Name	City	State
United States	Texas Tech University Health Scince Center El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSQ-18 General Satisfaction	General satisfaction component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable).	1 month after surgery (1-2 weeks after postoperative visit)
Primary	PSQ-18 Technical Quality	Technical Quality component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)	1 month after surgery (1-2 weeks after postoperative visit)
Primary	PSQ-18 Interpersonal Manner	Interpersonal manner component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)	1 month after surgery (1-2 weeks after postoperative visit)
Primary	PSQ-18 Communication	Communication component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)	1 month after surgery (1-2 weeks after postoperative visit)
Primary	PSQ-18 Time Spent With Doctor	"Time spent with doctor" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)	1 month after surgery (1-2 weeks after postoperative visit)
Primary	PSQ-18 Accessibility and Convenience	"Accessibility and convenience" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)	1 month after surgery (1-2 weeks after postoperative visit)
Secondary	Actual Visit Time	Time that the actual postoperative encounter took, originally to be measured in seconds, and then rounded to the nearest minute for reporting. This is measured at the time of visit by research staff using a stop-watch.	Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery
Secondary	Visits to Emergency Department	Number of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery	30 days after surgery
Secondary	Phone-calls to Office	Number of phone-calls made to office for postoperative complaints occurring after postoperative visit, within 30 days of the surgery	30 days after surgery
Secondary	Time Dedicated by Patient to Complete Visit	Patient estimate of the time it took them to complete the postoperative visit, including transportation to and from the clinic (if randomized to office visit group). Measured in minutes (increments of 5)	1 month after surgery (1-2 weeks after postoperative visit)
Secondary	Number of Patients Who Desired to Switch Groups	Participants who responded YES when asked during the final interview (1-2 weeks after postoperative visit) if they would've switched groups if given the chance.	1 month after surgery (1-2 weeks after postoperative visit)