Clinical trial NCT04056663: Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
Official title: Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Chronic Disease
Keywords: Artificial Intelligence
Continuity of Patient Care
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background - There is a high potential for hospitalization prevention through: (i) a greater continuity of care, achieved by facilitating collaborative work among professionals at different levels of care, and (ii) improving the self-efficacy of patients. For both objectives, the support of appropriate information and communication technologies is essential. The study raises the hypothesis that an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, will facilitate a greater continuity of care and an improvement in patients' self-efficacy.

Objective - Analysis of Health-Circuit's potential for improving the continuity of care and self-efficacy of chronic patients at risk of hospitalization.

Material and methods - Controlled, single-blinded, randomized trial by primary care teams, with a 2:1 intervention-control ratio. The first phase of the study (September-November 2019) will be carried out in 75 patients from the primary care area of Barcelona Esquerra under the influence of Hospital Clínic of Barcelona (CAPSBE, 110k inhabitants). In the intervention group, the patients, and the corresponding healthcare professionals, will communicate and collaborate though Health-Circuit, while the control group will receive conventional treatment. In a second phase (beginning December 2019), the study will be extended to the entire healthcare area of Barcelona Esquerra (AISBE, 520k inhabitants).

Expected results - From a clinical perspective, a reduction in the number of urgent face-to-face visits is expected at: (i) Hospital; (ii) Primary Care, or, (iii) Primary Care Emergency Centers, due to better continuity of care and greater self-efficacy of patients. However, the results sought in Phase I of the study will be, fundamentally: (i) the evaluation of the usability and acceptability of Health-Circuit for patients and professionals, and (ii) the analysis of the potential of the digital tool for the management of complex clinical processes with the help of intelligent bots. In phase II of the study, the central objectives will be (i) increase in the capacity to resolve events, and (ii) improvement of patients' self-efficacy.

Detailed description: The present investigation develops in the framework of the EU project CONNECARE "Personalized Connected Care for Complex Chronic Patients (H2020 - BHC25 - 689802), whose registration number in the medical research ethics committee of Hospital Clínic of Barcelona is HCB / 2018/0803. CONNECARE assumes that (i) the improvement of the continuity of care, associated with facilitating collaborative work among professionals of different levels of care, and, (ii) the increase in patients' self-efficacy, results in an optimization of the management of chronic patients with the consequent decrease in unplanned consultations, whether at primary care or at the hospital. This necessarily leads to an increase in the resolving capacity of primary care teams and an increase in the prevention of hospitalizations.

Although the role of digital technologies, as an element of support for integrated care services, is well-demonstrated, at present, we still do not have adequate digital tools that provide adequate support for collaborative work between professionals and, in turn, encourage the empowerment for self-management of patients. We understand as such, technologies: (i) compliant with the General Data Protection Regulation (GDPR), (ii) interoperable with existing health information systems, and, that (iii) facilitate the adaptive and collaborative management of chronic patients.

The present study evaluates the potential of an industry 4.0 system, Health-Circuit, based on communication technologies and intelligent collaboration, for the improvement of the management of chronic patients, with the consequent increase of the resolving capacity of the community health teams. Health-Circuit allows patients and professionals to interact, bilaterally or in groups, from various information systems and devices, regardless of their physical location. The base technology platform, Circuit, is robust (TRL 9), located in the cloud (private, mixed or public) and complies with the General Data Protection Regulation (GDPR). Circuit allows multimedia corporate communication (chat, call, video-call, file exchange, etc.) between healthcare levels, increasing coordination among professionals with the consequent improvement of health outcomes. Its potential can be increased in the future with the use of intelligent Chatbots to guide patients and professionals through complex care processes, providing decision support for personalised service selection by means of enhanced health risk assessment and patient stratification.

Eligibility criteria: Inclusion Criteria:

* Participation in the SELFIE study.
* Accepting to participate in the study and sign the consent.
* In the intervention group, having a "smart phone" or "Tablet" that can support the use of the computer tool (versions of the operating systems Android or iOS compatible with the patient's application) and having an internet connection.

Exclusion Criteria:

* Physical or psychological health problems that prevent the use of the tool and that the patient does not have the help of a caregiver.

Primary outcomes:
measure: Unplanned visits
timeFrame: 3 months
Secondary outcomes:
measure: Service utilization measures
timeFrame: 3 months
measure: Change in The Health Empowerment Scale
timeFrame: 3 months
measure: Change in the Fantastic Lifestyle questionnaire
timeFrame: 3 months
measure: Equipment failures
timeFrame: 3 months
measure: Software failures
timeFrame: 3 months
measure: Errors in execution
timeFrame: 3 months
measure: Number of errors due to the participant's temporary functions
timeFrame: 3 months
measure: Errors due to failures in the organization
timeFrame: 3 months
measure: Number of participants in the study with respect to the total of potential participants
timeFrame: 3 months
measure: Number of entries to the application (app) per patient
timeFrame: 3 months
measure: Number of contacts with clinical professionals responsible for managing the case
timeFrame: 3 months
measure: Number of video calls
timeFrame: 3 months
measure: Number of patients who have accessed the conditions of use
timeFrame: 3 months
measure: Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
timeFrame: 3 months
measure: Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
timeFrame: 3 months
measure: Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
timeFrame: 3 months
measure: Patient mHealth tool usability assessed by the System Usability Scale
timeFrame: 3 months
measure: Professional mHealth tool usability by the System Usability Scale
timeFrame: 3 months
measure: Patient mHealth experience
timeFrame: 3 months
measure: Professional mHealth experience
timeFrame: 3 months
measure: Number of clinical diagnoses in app users
timeFrame: 3 months
measure: Degree of severity of the symptom
timeFrame: 3 months
measure: Duration of the symptom
timeFrame: 3 months
measure: Number of professionals that the manager has contacted through the app
timeFrame: 3 months
measure: Number of interactions between professionals through the app
timeFrame: 3 months
measure: Number of solutions provided only by the manager
timeFrame: 3 months
measure: Number of solutions provided by the primary care professional
timeFrame: 3 months
measure: Number of solutions that has been a virtual visit
timeFrame: 3 months
measure: Number of solutions that has been a classroom visit
timeFrame: 3 months
measure: Number of referrals to the emergency department regarding the total number of solutions
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
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