Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 主要终点
- Length of hospitalization after surgery and complications during and after hospitalization
研究概览
简要总结
The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries.
The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver.
Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.
详细描述
The intervention in this study consists of three parts:
- Empowering the patient to self-manage his or her health by using applications for smart devices.
- Intensive pre-habilitation plan with close monitoring during the month prior to surgery.
- Integrative treatment in the community, which includes a close followup with a coordinating nurse for three months after discharge from the hospital.
The study protocol:
- Recruitment of participants after scheduling a major elective surgery, explanation of the study and signing the consent form.
- Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
- Distribution of research kit and related accessories and training.
- Close monitoring during pre habilitation plan for a month prior to surgery.
- Reassessment of the patient after the surgery and before discharge from the hospital.
- Close monitoring during three months in the community after discharge from the hospital and use of the research kit.
- Reassessment of the patient at the exit of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Maccabi members who were scheduled for a major elective surgery
- •Age over 65
- •Living in a home and not in a nursing home
- •Anesthesiologist ASA score evaluation of levels 2 or 3 only
- •Diagnosis of at least one chronic disease of the following - COPD, cardiovascular disease, diabetes, hypertension, cancer or obesity.
- •The patient and / or the main caregiver speak Hebrew, English or Russian
- •The patient or primary caregiver has a password to the Maccabi Online website
- •The patient and / or the primary caregiver have basic technological knowledge in the use of the applications
- •The patient has wireless Internet access at home (via Wifi or through a cellular connection)
排除标准
- •Patients with cognitive or dementia problems
研究组 & 干预措施
Intervention group
Implementing the Connecare system to support integrated care for complex patients who are plan to undergo a major elective surgery in Assuta Ashdod and are discharged back to the community with an emphasis on Connecare self managment system for the patient and close follow up and coordination of all of the medical, health and social care in the community for two periods of time: (1) Pre habilitation plan for a month prior to surgery (2) a period of 3 months post discharge.
干预措施: Connecare self managment system (Device)
No Intervention: Matched control group
The control group will be selected from Maccabi's database and will be patients who are matched 1:1 with the intervention sample and live in another community similar to Ashdod in socioeconomic characteristics who undergo the same elective major surgery in other hospitals
结局指标
主要结局
Length of hospitalization after surgery and complications during and after hospitalization
时间窗: Less then one month
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
时间窗: One month
Number of hospitalizations and emergency room visits after discharge
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
时间窗: One year
Number of hospitalizations and emergency room visits after discharge
Length of hospitalization
时间窗: Less then one month
In days
次要结局
- Compliance with the assignments in the discharge program guidelines(One year)
- Community health services use(One year)
- Evaluation of usability of the technology systems developed(One year)
- Cost-benefits evaluation for the intervention(One year)
- Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)(One year)
- Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)(One year)
研究者
Dr Bellaa Azria
Head of Medicine, Assuta Medical Centers
Assuta Medical Center