ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 6-min walk distance
研究概览
简要总结
In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.
详细描述
This pilot study aims to evaluate the feasibility of collecting patient generated health data (PGHD) remotely for aiding care management of patients with chronic limb threatening ischemia following vascular bypass or revascularization. DRemote data collected from a publicly available smartwatch will be displayed on an EHR interface for providers to view PGHD. The test of feasibility entails multiple components that include implementing a provider interface for viewing and acting on PGHD, establishing safety, ensuring quality assurance (e.g. quality of remote data collection), successful recruitment and retention of participants, and sufficient remote response rates from patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)].
排除标准
- •High risk of post-surgical amputation based on study physician judgement, non-english speaker, diagnosis of an age-related dementia (e.g. Alzheimer's Disease); unable to communicate because of severe hearing loss; uncorrectable vision impairment that compromises clinical assessments or would cause a safety concern, other significant co-morbid disease that in the opinion of the investigators and study physician would impair the ability to participate in the study or be a safety concern
研究组 & 干预措施
ROAMM-EHR
Patients will wear a smartwatch equipped with a smartwatch app before their surgery and for approximately a month after the surgery. Patients will be asked to wear the watch every day when awake. When wearing the smartwatch, patients will be asked questions about their symptoms following surgery and data will be sent to providers electronically and displayed in their EHR portal. Healthcare Providers will use this information along with patient medical history to decide on the next course of action. The study does not provide specific instructions about how to care for the patient. Those decisions are made by the provider team and their clinical judgement.
干预措施: Actionable remotely generated health data (Behavioral)
Active Comparison
The active comparison patients will wear and respond to questions on the smartwatch. However, the information will not be viewable by their doctor and medical team. All standard of care procedures will remain.
干预措施: Non-Actionable remotely generated health data (Behavioral)
结局指标
主要结局
6-min walk distance
时间窗: Baseline and approximately 30 days post-surgery
Patients are asked to complete as much distance as possible over a standardized course
次要结局
- self-reported quality of life(Baseline and approximately 30 days post-surgery)