Effect of Continuity of Care With Digital Home Monitoring on Postoperative Outcomes in Patients Undergoing Thoracic Surgery: A Pilot Randomized Controlled Trial (CDHM: RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Protocol adherence
研究概览
简要总结
Background and Importance: When patients transition from hospital to home following surgery, perceived complications or poorly controlled pain can result in emergency department visits and readmissions. Continuity of care after discharge has been shown to reduce ED visits and readmissions rates. Hence any improved method of extending the continuity of care in a patient's home may improve postoperative outcomes. For patients who are at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behaviour, and creating better outcomes. Care teams can understand what's going on with each patient daily or weekly, as opposed to sporadically through an office visit.
Goals/Research Aims: Atrial fibrillation is one of the important complications after thoracic surgery, it is estimated to occur in 10.5% of patients. We will conduct a randomized controlled trial to test the use of a secured digital system to monitor vital signs and home-based ECG monitoring for 2 weeks after surgery in patients undergoing an elective thoracic surgical procedure at the London Health Sciences Centre [LHSC]. Specific objectives are to determine the feasibility of 30-day emergency department visits as the primary outcome, 30-day readmission rates, postoperative complications, in-hospital length of stay, pain scores, hospital case costing, societal costs, mortality, and patient satisfaction.
Methods/Approaches/Expertise: This trial will be a single centre, assessor-blinded, parallel arm, randomized controlled trial. Participants will be recruited from patients scheduled for thoracic surgical procedures at LHSC. Patients will be randomized to either the Continuity of care with Digital Home Monitoring (CDHM) group or the control group. The control group will be provided with the usual post-operative care, and the CDHM group will be provided with access to self-help resources, digital monitoring and access to a clinical navigator for two weeks. All outcomes will be compared between the CDHM group and control group at the end of 4 weeks post-discharge, including out-of-pocket costs, travel costs and lost productivity.
Expected Outcomes: The Ontario Hospital Association estimates the average cost of a one-day stay in an acute care hospital is $1,300. With digital monitoring and continuity of care, we expect to decrease visits and readmission rates by at least 50% and in-hospital length stay by at least one day. This is a feasibility study. We will follow the traffic light approach criteria for reporting feasibility outcomes: Feasible (green) 75-100%: all feasibility outcomes are met; no protocol modifications are needed; (2) Feasible with modification (amber) 50-75%: all feasibility outcomes are met or can be met with protocol modifications; (3) Not feasible (red) <50%: even with protocol modifications, some feasibility outcome cannot be met.
详细描述
Introduction: Surgical recovery after discharge from the hospital often poses confusion and challenges for patients and caregivers. This is more so when early dismissal after surgery has become the norm. Furthermore, the Canadian health care system is fragmented, with poorly integrated services. Thus, when patients transition from hospital to home following surgery, complications and inadequately controlled pain results in return to hospital or ED visits. Family caregivers are frustrated that health care providers involved in different aspects of a patient's care do not always communicate with one another, resulting in caregivers having to retell a patient's story and spending unnecessary time clarifying information during the ED visits. Caregivers and healthcare providers are looking for one clear point of contact that ensures patients' needs are met at every segment of their healthcare journey. Patients believe that when they receive care, it is generally of high quality. Despite the positive feedback from the patients about the quality of care, the system continues to struggle with transitional care due to a lack of system-wide integration.
This randomized controlled trial on continuity of care with digital home monitoring for four weeks post-operatively in patients undergoing an elective thoracic surgical procedure.
Eligible patients will be recruited from the surgeon's office, and informed consent will be obtained. Patients will be randomized to the control group (no digital care) or the intervention groups (digital care provided). Intraoperative and immediate postoperative care in the post-anesthesia care unit (PACU) and surgical ward will remain the same for all patients. At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated once a day for two weeks. The control group will not be monitored with continuity of care. After this period, 30-day emergency department visits will be measured and compared between the two groups, along with 30-day readmission rates, in-hospital length of stay, mortality, quality of recovery 40 item scale (QoR-40), European Quality of Life 5 Dimensions (EQ5D), patient satisfaction score, and societal and hospital cost.
ED visits and readmission rate: In Ontario, between 2014 and 2016, within 30 days after lung cancer lobectomy surgery, the readmission rate was 5.9%, and the Emergency Department (ED) visit rate was 16.2%.(1) At the LHSC, the 30-day ED visit rates were 21.5% [95% CI 15.91, 27.14], and the 30-day readmission rates were 6.73% [95% CI 3.21, 10.24] for lung cancer lobectomy.(1) Between 2015/2016 and 2017/2018, unadjusted data of readmissions or ED visits within seven days after Video Assisted Thoracoscopic Surgery (VATS) and open thoracotomy were 9% and 7%, respectively, at LHSC. Post-surgical discharge hospital visits remain a significant problem in post-thoracic surgical care. Patients have to wait too long during ED visits, which negatively impacts provider, caregiver and patient well-being. The investigators believe that a virtual care option extending the continuity of care post-discharge is a viable solution to this problem.
Digital solution - virtual care: In the last few years, the focus on patient care has moved from clinical to home. Now, more than ever, it is necessary to engage patients before, throughout the perioperative period, and in rehabilitation, post-surgery to ensure the best possible patient health outcomes while reducing LOS and unplanned readmissions. Ensuring patients are prepared to adhere to the post-surgical plan of care once released from the hospital can increase the length of hospital stay by as much as 25%. Digital solutions can alleviate the problem by enabling remote monitoring of a patient's vital signs, symptoms and behaviour at home, sending medication reminders, monitoring medication use and the patient's understanding of the self-care content it is delivering, ensuring patients remain on the pathway toward better health, finally improving the patient's outcomes.
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
- Single (Outcomes Assessor)
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
- •Patient willing to provide informed consent
- •Availability of a caregiver at the patient's home
- •Wi-fi or cellular connectivity at the patient's home
- •Undergoing elective segmentectomy, lobectomy, or pneumonectomy; VATS or open procedure and any thoracic foregut procedure like esophagectomy etc
- •ASA III or lower
- •Ability to comprehend and consent in English
- •Patient or caregiver familiar/comfortable with the use of the technology like online banking
排除标准
- •Unstable disease process preoperatively
- •Patient requiring postoperative ICU admission
- •Expected unstable disease process in the postoperative period
结局指标
主要结局
Protocol adherence
时间窗: 1 year
As collected on the Case Report Forms and loss-to-follow-up
Outcome data collection
时间窗: 1 year
Data will be collected from the patient on the vitals and daily assessment on the video call.
Trial Recruitment
时间窗: 1 year
Number of patients recruited over the period of the study, a measure of study feasibility
次要结局
- 30 day ED visit; 30 day readmission rate; cost analysis etc(30 days postoperatively)
- Patient satisfaction score(30 days postoperatively)
- Patient/caregiver experience(30 days postoperatively)
研究者
Yamini Subramani
Assistant Professor
Western University, Canada
