Laparoscopic Gynecologic SurgeryTelemedicineNCT04348357
Utilizing Telemedicine for Delivery of Postoperative Care
A study testing Telemedicine and Office visit in people with Laparoscopic Gynecologic Surgery, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Laparoscopic Gynecologic Surgery
- What is being tested?
- Telemedicine and Office visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 6 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patient unwilling to participate
- The patient is unwilling to install and utilize the telemedicine app on their smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Scince Center El Paso
El Paso, Texas, 79905
About this study
Official title: Utilizing Telemedicine for Delivery of Postoperative Care Following Minimally-invasive Gynecologic Surgery: A Randomized Controlled Trial
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.
Read the 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
- Determine if there are differences in patient satisfaction between traditional postoperative visits and telemedicine postoperative visits
- Determine the difference in time invested from the patient's side and clinicians side in order to complete the postoperative visit interaction
- 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
- Conditions
- Laparoscopic Gynecologic Surgery
- Being tested
- Telemedicine, Office visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
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 visitOther
Patient comes to the office to receive routine postoperative care
| Study group | Role | What they receive |
|---|---|---|
| Traditional Visit | Active comparator | Patients come to the office for a traditional postoperative visit Receives: Other: Office visit |
| Tele-medicine | Experimental | Patients receive postoperative care via telemedicine Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
Secondary outcomes (5)
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: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery
Visits to Emergency Department
Number of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery
Measured: 30 days after surgery
Phone-calls to Office
Number of phone-calls made to office for postoperative complaints occurring after postoperative visit, within 30 days of the surgery
Measured: 30 days after surgery
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)
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
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.
Measured: 1 month after surgery (1-2 weeks after postoperative visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start21 Jun 2019
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Radtke, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Steven Radtke, MD, Principal investigator, TTUHSCEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348357
- Sponsor's protocol ID
- E19110
- Acronym
- Telemedicine
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2020
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Telemedicine for Delivery of Postoperative Care Following Minimally-invasive Gynecologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04348357
- Acronym / sponsor ID
- Telemedicine / E19110
- Conditions
- Laparoscopic Gynecologic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Determine if there are differences in patient satisfaction between traditional postoperative visits and telemedicine postoperative visits
- Determine the difference in time invested from the patient's side and clinicians side in order to complete the postoperative visit interaction
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Visit | Active comparator | Other: Office visitPatients come to the office for a traditional postoperative visit |
| Tele-medicine | Experimental | Other: TelemedicinePatients receive postoperative care via telemedicine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient unwilling to participate
- The patient is unwilling to install and utilize the telemedicine app on their smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineA 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) | Other | Tele-medicine |
| Office visitPatient comes to the office to receive routine postoperative care | Other | Traditional Visit |
Primary outcome
PSQ-18 General Satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
PSQ-18 Accessibility and Convenience
Time frame: 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)
5 secondary outcomes
Actual Visit Time
Time frame: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery
Visits to Emergency Department
Time frame: 30 days after surgery
Phone-calls to Office
Time frame: 30 days after surgery
Time Dedicated by Patient to Complete Visit
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
Number of Patients Who Desired to Switch Groups
Time frame: 1 month after surgery (1-2 weeks after postoperative visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Radtke, MD principal investigator
TTUHSCEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and Office visit in people with Laparoscopic Gynecologic Surgery, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQ-18 General Satisfaction (time frame: 1 month after surgery (1-2 weeks after postoperative visit)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.