CONNECARE-Assuta-Case Study 2

Integrated Personalized Connected Care and Preventive Patient-centred Intervention for Complex Chronic Patients Undergoing Elective Major Surgical Procedures

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Disease; Old Age; Debility
• Intervention / Treatment: Device: Connecare self managment system

Detailed Description

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
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reut Ron, M.SC; Phone Number: +972-542240225; Email: Reutro@assuta.co.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Patients with cognitive or dementia problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Connecare self managment system; 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital	Number of hospitalizations and emergency room visits after discharge	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	One year
Length of hospitalization	In days	Less then one month
Length of hospitalization after surgery and complications during and after hospitalization		Less then one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	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	One year

Collaborators and Investigators

• Sponsor: Assuta Medical Center
• Collaborators: European Commission
• Investigators: Study Director: Bella Azaria, Doctor, Assuta Medical Center

Publications and helpful links

Helpful Links

• The European Union's Horizon 2020 Call for Action

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Frailty
• Other Study ID Numbers: 0036-17-ASMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No