Laparoscopic Gynecologic Surgery
Conditions
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
Interventions
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)
Patient comes to the office to receive routine postoperative care
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSQ-18 Accessibility and Convenience | 1 month after surgery (1-2 weeks after postoperative visit) | 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) |
| PSQ-18 General Satisfaction | 1 month after surgery (1-2 weeks after postoperative visit) | 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). |
| PSQ-18 Technical Quality | 1 month after surgery (1-2 weeks after postoperative visit) | 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) |
| PSQ-18 Interpersonal Manner | 1 month after surgery (1-2 weeks after postoperative visit) | 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) |
| PSQ-18 Communication | 1 month after surgery (1-2 weeks after postoperative visit) | 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) |
| PSQ-18 Time Spent With Doctor | 1 month after surgery (1-2 weeks after postoperative visit) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visits to Emergency Department | 30 days after surgery | Number of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery |
| Phone-calls to Office | 30 days after surgery | Number of phone-calls made to office for postoperative complaints occurring after postoperative visit, within 30 days of the surgery |
| Time Dedicated by Patient to Complete Visit | 1 month after surgery (1-2 weeks after postoperative 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) |
| Number of Patients Who Desired to Switch Groups | 1 month after surgery (1-2 weeks after postoperative visit) | 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. |
| Actual Visit Time | Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Visit Patients come to the office for a traditional postoperative visit
Office visit: Patient comes to the office to receive routine postoperative care | 25 |
| Tele-medicine Patients receive postoperative care via telemedicine
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) | 16 |
| Total | 41 |
Baseline characteristics
| Characteristic | Tele-medicine | Total | Traditional Visit |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 8.3 | 42.1 years STANDARD_DEVIATION 7.9 | 41.4 years STANDARD_DEVIATION 7.6 |
| BMI | 30.6 kg/m^2 STANDARD_DEVIATION 6.1 | 31.4 kg/m^2 STANDARD_DEVIATION 6 | 31.9 kg/m^2 STANDARD_DEVIATION 6.1 |
| Distance from clinic | 12.5 miles STANDARD_DEVIATION 6.2 | 12.6 miles STANDARD_DEVIATION 6.8 | 12.7 miles STANDARD_DEVIATION 7.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 41 participants | 25 participants |
| Sex: Female, Male Female | 16 Participants | 41 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 16 |
| other Total, other adverse events | 0 / 25 | 0 / 16 |
| serious Total, serious adverse events | 0 / 25 | 0 / 16 |
Outcome results
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 Accessibility and Convenience | 4.0 score on a scale |
| Tele-medicine | PSQ-18 Accessibility and Convenience | 4.0 score on a scale |
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 Communication | 4.5 score on a scale |
| Tele-medicine | PSQ-18 Communication | 4.5 score on a scale |
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).
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 General Satisfaction | 4.0 score on a scale |
| Tele-medicine | PSQ-18 General Satisfaction | 4.5 score on a scale |
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 Interpersonal Manner | 4.0 score on a scale |
| Tele-medicine | PSQ-18 Interpersonal Manner | 4.5 score on a scale |
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 Technical Quality | 4.0 score on a scale |
| Tele-medicine | PSQ-18 Technical Quality | 4.5 score on a scale |
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Visit | PSQ-18 Time Spent With Doctor | 4.0 score on a scale |
| Tele-medicine | PSQ-18 Time Spent With Doctor | 4.5 score on a scale |
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.
Time frame: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Visit | Actual Visit Time | 9.2 minutes | Standard Deviation 4 |
| Tele-medicine | Actual Visit Time | 9.1 minutes | Standard Deviation 2.6 |
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.
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Visit | Number of Patients Who Desired to Switch Groups | 2 Participants |
| Tele-medicine | Number of Patients Who Desired to Switch Groups | 0 Participants |
Phone-calls to Office
Number of phone-calls made to office for postoperative complaints occurring after postoperative visit, within 30 days of the surgery
Time frame: 30 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Traditional Visit | Phone-calls to Office | 6 Number of phonecalls |
| Tele-medicine | Phone-calls to Office | 5 Number of phonecalls |
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)
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Visit | Time Dedicated by Patient to Complete Visit | 60.8 minutes | Standard Deviation 45.8 |
| Tele-medicine | Time Dedicated by Patient to Complete Visit | 14.7 minutes | Standard Deviation 11.9 |
Visits to Emergency Department
Number of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery
Time frame: 30 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Traditional Visit | Visits to Emergency Department | 1 number of ER visits |
| Tele-medicine | Visits to Emergency Department | 0 number of ER visits |