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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
400
Health-Circuit as a collaborative tool between professionals and patient and professionals
Hospital Clínic
Barcelona, Spain
Unplanned visits
Number of unplanned primary care and hospital visits
Time frame: 3 months
Service utilization measures
number of primary care and hospital visits, number of remote resolutions and number of hospitalizations
Time frame: 3 months
Change in The Health Empowerment Scale
The instrument retained 8 items, scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of health-related empowerment.
Time frame: 3 months
Change in the Fantastic Lifestyle questionnaire
This questionnaire contains 25 closed items that you explore nine related physical, psychological and social categories or domains to the lifestyle. It presents three response options with a numerical value of 0 to 2 for each category, and they are graded using a Likert scale, with a score of 0 to 100 points. Taking as a cut-off point the average of the qualifications proposed by the authors of the instrument five levels of qualification stratify the behavior: (\<39 points = danger exists, 40 to 59 points = bad, 60 to 69 points = regular , 70 to 84 points = good, 85 to 100 points = excellent) lifestyle. The lower the score, the greater the need for change.
Time frame: 3 months
Equipment failures
Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures
Time frame: 3 months
Software failures
Number of software failures described as slowdown in execution, information delay, command rows or information not available
Time frame: 3 months
Errors in execution
Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action
Time frame: 3 months
Number of errors due to the participant's temporary functions
Number of errors due to the participant's temporary functions described as forgetfulness, incorrect memory, incomplete memory, random actions, stoppage of actions, suspended task, task not completed, objective forgotten or loss of orientation
Time frame: 3 months
Errors due to failures in the organization
Number of errors due to failures in the organization described as anthropometric problems or inadequate interface
Time frame: 3 months
Number of participants in the study with respect to the total of potential participants
Number of participants in the study with respect to the total of potential participants of: i. Patients ii. Professionals
Time frame: 3 months
Number of entries to the application (app) per patient
Number of entries to the application (app) per patient
Time frame: 3 months
Number of contacts with clinical professionals responsible for managing the case
Number of contacts with clinical professionals responsible for managing the case that will be contacted through the technological tool (mHealth manager): i. Number of total contacts. ii. Number of patients who have contacted
Time frame: 3 months
Number of video calls
Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call.
Time frame: 3 months
Number of patients who have accessed the conditions of use
Number of patients who have accessed the conditions of use
Time frame: 3 months
Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
It consists of four questions selected from the domain Collaboration between care of the Nijmegen Continuity of Care Questionnaire. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Time frame: 3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
Time frame: 3 months
Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
The Net Promoter Score is calculated based on the answers to a single question. The result is calculated by dividing the percentage of promoters (who have a score of 9-10) minus the percentage of detractors (who have a score of 0-6). The percentage of "liabilities" (which obtained a score of 7-8) is not included in the NPS calculation. The NPS varies between -100 and +100. A positive score is considered good. The three custom made general satisfaction question is scored on a 5-point Likert scale that ranges from 0 (poor) to 10 (Good).
Time frame: 3 months
Patient mHealth tool usability assessed by the System Usability Scale
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Time frame: 3 months
Professional mHealth tool usability by the System Usability Scale
The System Usability Scale is a 10 item questionnaire with 5 response options. Scored on a 5 points Likert scale ranging from 5 (strongly agree) to 1 (strongly disagree). Higher scores indicate stronger level of Collaboration between care providers from the patient's perspective.
Time frame: 3 months
Patient mHealth experience
Two open questions regarding negative and positive aspects of the use of the computer tool
Time frame: 3 months
Professional mHealth experience
Two open questions regarding negative and positive aspects of the use of the computer tool
Time frame: 3 months
Number of clinical diagnoses in app users
number of high priority clinical diagnoses in app users according to CIE10 in medical history
Time frame: 3 months
Degree of severity of the symptom
Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious
Time frame: 3 months
Duration of the symptom
Duration of the symptom expressed in hours, days or weeks
Time frame: 3 months
Number of professionals that the manager has contacted through the app
Number of professionals that the manager has contacted through the app
Time frame: 3 months
Number of interactions between professionals through the app
Number of interactions between professionals through the app
Time frame: 3 months
Number of solutions provided only by the manager
Number of solutions provided only by the manager regarding the number of total solutions
Time frame: 3 months
Number of solutions provided by the primary care professional
Number of solutions provided by the primary care professional regarding the number of total solutions
Time frame: 3 months
Number of solutions that has been a virtual visit
Number of solutions that has been a virtual visit with the primary care professional regarding the total number of solutions
Time frame: 3 months
Number of solutions that has been a classroom visit
Number of solutions that has been a classroom visit with the primary care professional regarding the total number of solutions
Time frame: 3 months
Number of referrals to the emergency department regarding the total number of solutions
Number of referrals to the emergency department regarding the total number of solutions
Time frame: 3 months
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