Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging: a Randomized Control Trial (PROMPT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Mean total score on FACT-G
研究概览
简要总结
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or greater.
- •Planning to undergo a surgical procedure via a laparotomy incision for a suspected or known gynecologic malignancy. There is no restriction on the spectrum of pathology or disease.
- •The ability and willingness to send and receive short messaging service (SMS) text messages.
- •Able to read and understand English.
- •Willing and able to provide informed consent
排除标准
- •Persons who are planning to undergo a minimally invasive procedure without laparotomy.
- •Persons unable to be contacted by SMS text message or choose to opt-out of the study.
- •Patients who do not have access to the internet via a home computer or a smart phone.
结局指标
主要结局
Mean total score on FACT-G
时间窗: 30-32 days post-operative
The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL.
次要结局
- Proportion of patients who called the care team(30 days post-operative)
- Proportion of patients seen in emergency room(30 days post-operative)
- Proportion of patients readmitted to hospital(30 days post-operative)
- Proportion of patients who had non-standard clinic visits(30 days post-operative)
- Proportion of patients seen in urgent care clinics(30 days post-operative)