Utilizing Telemedicine for Delivery of Postoperative Care Following Minimally-invasive Gynecologic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- PSQ-18 Technical Quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient unwilling to participate
- •The patient is unwilling to install and utilize the telemedicine app on their smartphone.
结局指标
主要结局
PSQ-18 Technical Quality
时间窗: 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
时间窗: 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 Time Spent With Doctor
时间窗: 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
时间窗: 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
时间窗: 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 Communication
时间窗: 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)
次要结局
- Actual Visit Time(Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery)
- Visits to Emergency Department(30 days after surgery)
- Phone-calls to Office(30 days after surgery)
- Time Dedicated by Patient to Complete Visit(1 month after surgery (1-2 weeks after postoperative visit))
- Number of Patients Who Desired to Switch Groups(1 month after surgery (1-2 weeks after postoperative visit))
研究者
Steven Radtke
Assistant Professor
Texas Tech University Health Sciences Center, El Paso