Integrated Personalized Connected Care for Complex Chronic Patients - Community-based Management
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 主要终点
- Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
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 two parts:
- Integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital.
- Empowering the patient to self-manage his or her health by using applications for smart devices.
The study protocol:
- Recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, 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 for 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 arrive at the ER in an unplanned manner
- •Age over 65
- •Living in a home and not in a nursing home
- •At least three of the following conditions:
- •Multiple drugs - regular use of four or more drugs
- •More than one case of hospitalization or visit to the ER in the past year
- •Malnutrition
- •Elements of low socio-economic status
- •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 with an unplanned admission to Assuta Ashdod who 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 by a Maccabi integrated care nurse for a period of 3 months post discharge.
干预措施: Connecare self managment system (Device)
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
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
Length of hospitalization
时间窗: Less then one month
In days
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
次要结局
- Cost-benefits evaluation for the intervention(One year)
- Evaluation of usability of the technology systems developed(One year)
- Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)(One year)
- Compliance with the assignments in the discharge program guidelines(One year)
- Community health services use(One year)
- Assessment of satisfaction of patients 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