Utilizing Telemedicine for Delivery of Postoperative Care

NCT ID: NCT04348357

Last Updated: 2020-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2020-05-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Gynecologic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traditional Visit

Patients come to the office for a traditional postoperative visit

Group Type ACTIVE_COMPARATOR

Office visit

Intervention Type OTHER

Patient comes to the office to receive routine postoperative care

Tele-medicine

Patients receive postoperative care via telemedicine

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

Office visit

Patient comes to the office to receive routine postoperative care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven Radtke

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Radtke, MD

Role: PRINCIPAL_INVESTIGATOR

TTUHSCEP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Texas Tech University Health Scince Center El Paso

El Paso, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E19110

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.