SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42,808
- 试验地点
- 12
- 主要终点
- Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30
研究概览
简要总结
Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize symptom control. Growth in Internet access and proliferation of smartphones has created an opportunity to re-engineer cancer care delivery. Electronic symptom tracking and feedback is a promising strategy to improve symptom control. Electronic patient reported outcome (ePRO) monitoring of cancer symptoms has been shown to decrease symptom burden, improve quality of life, reduce acute care and even extend survival. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM
详细描述
A multi-disciplinary team of investigators from 6 health systems have formed the Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) Research Center. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM. eSyM is the name of the platform the team will refine, integrate, implement and evaluate. eSyM addresses each of the 4 evidence gaps by:
- Implementing eSyM in cancer centers in small, rural or community-based systems.
- Integrating eSyM into the EHR (electronic health record) of the predominant vendor used nationwide.
- Leveraging evidence-based tools, patient engagement, and population management.
- Executing this work using the Consolidated Framework for Implementation Research across all phases to maximize the chances that eSyM and similar systems achieve their intended goals and decrease the morbidity of cancer treatment at a population level.
This project contains 5 activities:
- Obtain stakeholder feedback
- Build and deploy eSyM
- Pilot test eSyM
- Pragmatic stepped-wedge cluster randomized trial
- Integration of eSyM data to develop algorithms to estimate the risk of experiencing an outcome, including, but not limited to, ED usage and hospitalization among cancer patients
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
- •Stakeholder Feedback and Stakeholder Qualitative Interviews Population:
- •Age ≥ 18 years
- •The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff
- •Cluster Randomized Trial, Patient QualitativeInterviews, Pilot Testing & SASS Questionnaire Population:
- •Age ≥ 18 years
- •Priority population will be patients who meet one of the following:
- •Suspected thoracic cancer [lung or bronchus] AND is inpatient following thoracic surgery.
- •Suspected gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND is inpatient following gastrointestinal surgery.
- •Suspected gynecologic cancer [ovary, uterus, or cervix] AND is inpatient following gynecologic surgery.
- •Diagnosis of thoracic cancer [lung or bronchus] AND scheduled to start a new treatment plan for thoracic cancer.
- •Diagnosis of gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND scheduled to start a new treatment plan for gastrointestinal cancer.
- •Diagnosis of gynecologic cancer [ovary, uterus, or cervix] AND scheduled to start a new treatment plan for gynecologic cancer.
- •Total population allowed to use eSyM:
- •Any patient at any participating site.
排除标准
- •- Participants not meeting the inclusion critera above.
结局指标
主要结局
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30
时间窗: 30 days
The primary study outcome of the stepped wedge cluster RCT (randomized controlled trial) is the EDTR rate. This outcome will be defined in relation to the date of discharge from hospital (surgical cohort) or the initiation date of a new intravenous chemo regimen (medical oncology cohort). This is a binary outcome and we will analyze the absolute difference and odds ratio for the medical oncology and surgical cohorts combined and independently.
次要结局
- Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90(90 days)
- Admissions Event Occurrence Status at Day 30(30 Days)
- Admissions Event Occurrence Status at Day 90(90 Days)
- Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Difference in Anxiety PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Difference in Pain Interference PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Difference in Self-Efficacy PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Difference in Physical Function PROMIS Scores Reported by Participants Before and After eSyM Exposure(30-90 days before and after eSyM go-live)
- Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)(30 days)
- Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)(90 days)
- Admissions Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)(30 Days)
- Admissions Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)(90 Days)
研究者
Michael Hassett, MD
Principal Investigator
Dana-Farber Cancer Institute