Remote Electronic Patient Monitoring in Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The Feasibility of Remote Electronic Patient Monitoring Intervention
研究概览
简要总结
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
详细描述
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Diagnosed with gastrointestinal cancer
- •Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- •Planning to receive outpatient care at the MGH Cancer Center
- •Ability to read and respond to questions in English
排除标准
- •Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- •Enrolled in hospice
- •Planning to be discharged to any location other than their home
结局指标
主要结局
The Feasibility of Remote Electronic Patient Monitoring Intervention
时间窗: 4 weeks
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
次要结局
- Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period(4 weeks)
- Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period(4 weeks)
- Patient-Reported Symptoms(2 weeks and 4 weeks)
- Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period(4 weeks)
- Number of intervention-triggered emails generated to the primary oncology team during study period(4 weeks)
- Number of concerning issues identified per patient during study period(4 weeks)
- Acceptability of Remote Electronic Patient Monitoring Intervention(4 weeks)
- Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period(4 weeks)
- Health Care Utilization(4 weeks)
- Patient-Reported Quality of Life(2 weeks and 4 weeks)
- Patient-Reported Depression and Anxiety Symptoms(2 weeks and 4 weeks)
研究者
Joseph A. Greer, Ph.D.
Principal Investigator
Massachusetts General Hospital