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Utilizing Telemedicine for Delivery of Postoperative Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04348357
Acronym
Telemedicine
Enrollment
53
Registered
2020-04-16
Start date
2019-06-21
Completion date
2020-05-06
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecologic Surgery

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

OTHERTelemedicine

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

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

MeasureTime frameDescription
PSQ-18 Accessibility and Convenience1 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 Satisfaction1 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 Quality1 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 Manner1 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 Communication1 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 Doctor1 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

MeasureTime frameDescription
Visits to Emergency Department30 days after surgeryNumber of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery
Phone-calls to Office30 days after surgeryNumber 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 Visit1 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 Groups1 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 TimeMeasured at the time of postoperative visit, which occurred 2-3 weeks after surgeryTime 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

ArmCount
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
Total41

Baseline characteristics

CharacteristicTele-medicineTotalTraditional Visit
Age, Continuous43.3 years
STANDARD_DEVIATION 8.3
42.1 years
STANDARD_DEVIATION 7.9
41.4 years
STANDARD_DEVIATION 7.6
BMI30.6 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 clinic12.5 miles
STANDARD_DEVIATION 6.2
12.6 miles
STANDARD_DEVIATION 6.8
12.7 miles
STANDARD_DEVIATION 7.3
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
16 participants41 participants25 participants
Sex: Female, Male
Female
16 Participants41 Participants25 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 16
other
Total, other adverse events
0 / 250 / 16
serious
Total, serious adverse events
0 / 250 / 16

Outcome results

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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 Accessibility and Convenience4.0 score on a scale
Tele-medicinePSQ-18 Accessibility and Convenience4.0 score on a scale
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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 Communication4.5 score on a scale
Tele-medicinePSQ-18 Communication4.5 score on a scale
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).

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 General Satisfaction4.0 score on a scale
Tele-medicinePSQ-18 General Satisfaction4.5 score on a scale
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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 Interpersonal Manner4.0 score on a scale
Tele-medicinePSQ-18 Interpersonal Manner4.5 score on a scale
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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 Technical Quality4.0 score on a scale
Tele-medicinePSQ-18 Technical Quality4.5 score on a scale
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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)
Traditional VisitPSQ-18 Time Spent With Doctor4.0 score on a scale
Tele-medicinePSQ-18 Time Spent With Doctor4.5 score on a scale
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.

Time frame: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery

ArmMeasureValue (MEAN)Dispersion
Traditional VisitActual Visit Time9.2 minutesStandard Deviation 4
Tele-medicineActual Visit Time9.1 minutesStandard Deviation 2.6
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.

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Traditional VisitNumber of Patients Who Desired to Switch Groups2 Participants
Tele-medicineNumber of Patients Who Desired to Switch Groups0 Participants
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

Time frame: 30 days after surgery

ArmMeasureValue (NUMBER)
Traditional VisitPhone-calls to Office6 Number of phonecalls
Tele-medicinePhone-calls to Office5 Number of phonecalls
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)

Time frame: 1 month after surgery (1-2 weeks after postoperative visit)

ArmMeasureValue (MEAN)Dispersion
Traditional VisitTime Dedicated by Patient to Complete Visit60.8 minutesStandard Deviation 45.8
Tele-medicineTime Dedicated by Patient to Complete Visit14.7 minutesStandard Deviation 11.9
Secondary

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

ArmMeasureValue (NUMBER)
Traditional VisitVisits to Emergency Department1 number of ER visits
Tele-medicineVisits to Emergency Department0 number of ER visits

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026