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.
The intervention in this study consists of three parts: 1. Empowering the patient to self-manage his or her health by using applications for smart devices. 2. Intensive pre-habilitation plan with close monitoring during the month prior to surgery. 3. 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: 1. Recruitment of participants after scheduling a major elective surgery, explanation of the study and signing the consent form. 2. Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study. 3. Distribution of research kit and related accessories and training. 4. Close monitoring during pre habilitation plan for a month prior to surgery. 5. Reassessment of the patient after the surgery and before discharge from the hospital. 6. Close monitoring during three months in the community after discharge from the hospital and use of the research kit. 7. Reassessment of the patient at the exit of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
220
The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them. In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
Length of hospitalization after surgery and complications during and after hospitalization
Time frame: Less then one month
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Number of hospitalizations and emergency room visits after discharge
Time frame: One month
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
Number of hospitalizations and emergency room visits after discharge
Time frame: One year
Length of hospitalization
In days
Time frame: Less then one month
Compliance with the assignments in the discharge program guidelines
At the time of discharge from the hospital, the patient receives a list of tasks to be performed as part of the release letter. We would like to know how many out of this tasks were carried out
Time frame: One year
Community health services use
Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
Time frame: One year
Evaluation of usability of the technology systems developed
Using questionnaires for nurses and patients to express their opinion on the use of the technology systems in the project and how much these systems assisted them
Time frame: One year
Cost-benefits evaluation for the intervention
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
Time frame: One year
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
Using satisfaction questionnaires to be passed at the end of the study
Time frame: One year
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
Using satisfaction questionnaires to be passed at the end of the study
Time frame: One year
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