跳至主要内容
临床试验/NCT06075316
NCT06075316招募中不适用

Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)

UNC Lineberger Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Reach of ePRO monitoring

研究概览

简要总结

This is a single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.

详细描述

Thoracic surgery patients are at high risk for severe complications post-surgery, such as respiratory failure, empyema, wound problems, and even mortality. Patients with complications may need readmission and invasive management. Usual care may not capture the symptoms of surgery complications. Well-designed remote monitoring of postoperative patients may enable early intervention and lower the risk of severe complications.

This study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (ePROs) monitoring in thoracic surgery patients. Previous studies demonstrated the feasibility of ePROs monitoring by thoracic surgery patients and providers. This study will explore barriers to implementation before real-world effectiveness studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:
  • 18 years or older
  • English or Spanish speaking
  • Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey
  • Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)
  • Discharged from the thoracic surgery service
  • Discharged to home

排除标准

  • All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:
  • Not completing planned surgery within 3 months of obtaining informed consent
  • Inability to understand English or Spanish
  • Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
  • Dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
  • Current incarceration

研究组 & 干预措施

ePRO monitoring

Other

Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.

干预措施: Symptom monitoring (Other)

结局指标

主要结局

Reach of ePRO monitoring

时间窗: Months 4 through 6 after implementation of the study

Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

Adoption of ePRO monitoring

时间窗: Months 4 through 6 after implementation of the study

Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery

Patient-level Uptake

时间窗: Months 4 through 6 after implementation of the study

the percentage of enrolled patients who participate in \>=1 ePRO survey.

Overall Reach of ePRO monitoring

时间窗: End of study

Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.

次要结局

  • Complication Rate(Baseline through 30 days post-discharge)
  • Emergency department visit at 30 days(Baseline through 30 days post-discharge)
  • Emergency department visit at 90 days(Baseline through 90 days post-discharge)
  • Readmission at 30 days(Baseline through 30 days post-discharge)
  • Readmission at 90 days(Baseline through 90 days post-discharge)
  • Mortality at 30 days(Baseline through 30 days)
  • Mortality at 90 days(Baseline through 90 days)
  • Patient Alert Rate(Baseline through 90 days)
  • Alert Rate(Baseline through 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验