Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Quality of Life at 12 Months
研究概览
简要总结
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Patients undergoing thoracic surgery will be asked to self-report symptoms for remote monitoring by their care team.
详细描述
This is a single center, randomized feasibility study. A total of 140 patients undergoing thoracic surgery will be prospectively enrolled and randomized in a 1:1 ratio to one of two arms. All participants will complete patient-reported outcome (PRO) symptom monitoring. The two arms are 1) active symptom monitoring and 2) passive symptom monitoring. The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. All participants will be administered survey instruments to assess quality of life, satisfaction, and health history. In addition, a subset of up to 40 participants will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •English speaking
- •Able and willing to complete web-based symptom survey
- •Be presenting for inpatient thoracic surgery
排除标准
- •Not completing planned surgery within 3 months of obtaining informed consent
- •Diagnosis of esophageal cancer
- •Inability to read and speak English
- •Presenting for a day surgery
- •Presenting for foregut surgery (e.g. paraesophageal hernia repair)
- •Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- •Current incarceration
- •Pregnancy
结局指标
主要结局
Quality of Life at 12 Months
时间窗: 12 months post-discharge
Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.
Lung Cancer Specific Quality of Life at 12 Months
时间窗: 12 months post-discharge
Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms
PRO Symptom Monitoring Surveys Completed at 3 Months
时间窗: 3 months post-discharge
The percentage of subjects who completed symptom surveys out of delivered symptom surveys.
PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months
时间窗: 3 months post-discharge
The percentage of survey alerts that generate a clinician response will be calculated.
Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
时间窗: assessed at 2 months through 2 years post-discharge
Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.
次要结局
- Readmission at 3 Months(3 months post-discharge)
- Overall Survival at 12 Months(12 months post-discharge)