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Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization (Health_Circuit)

9 février 2021 mis à jour par: Carmen Herranz, Hospital Clinic of Barcelona

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
      • Barcelona, Espagne, 08036
        • Hospital Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Health-Circuit mobile application

The intervention contemplates. (i) management of unexpected events; and, (ii) empowering the patient to improve self-efficacy.

Users of the intervention arm will have the Health-Circuit mobile application, which will offer them the possibility of contacting the case managers to notify a health event at any time and that this can be resolved by their health professionals through Health -Circuit. The improvement of the patient's self-efficacy for the management of their health problems through the use of Health-Circuit is considered through the virtual visits of follow-up with the manager, the possibility of interacting with the manager and the consultation of the shared documents reminders of the action plan agreed with the patient.
Comportemental: Health-Circuit mobile application
Health-Circuit as a collaborative tool between professionals and patient and professionals
Aucune intervention: Conventional treatment
Patients assigned to this group will follow conventional treatment. Once the three months have passed, we will contact you again to ask the pertinent questions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Unplanned visits
Délai: 3 months
Number of unplanned primary care and hospital visits
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Service utilization measures
Délai: 3 months
number of primary care and hospital visits, number of remote resolutions and number of hospitalizations
3 months
Change in The Health Empowerment Scale
Délai: 3 months
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.
3 months
Change in the Fantastic Lifestyle questionnaire
Délai: 3 months
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.
3 months
Equipment failures
Délai: 3 months
Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures
3 months
Software failures
Délai: 3 months
Number of software failures described as slowdown in execution, information delay, command rows or information not available
3 months
Errors in execution
Délai: 3 months
Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action
3 months
Number of errors due to the participant's temporary functions
Délai: 3 months
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
3 months
Errors due to failures in the organization
Délai: 3 months
Number of errors due to failures in the organization described as anthropometric problems or inadequate interface
3 months
Number of participants in the study with respect to the total of potential participants
Délai: 3 months
Number of participants in the study with respect to the total of potential participants of: i. Patients ii. Professionals
3 months
Number of entries to the application (app) per patient
Délai: 3 months
Number of entries to the application (app) per patient
3 months
Number of contacts with clinical professionals responsible for managing the case
Délai: 3 months
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
3 months
Number of video calls
Délai: 3 months
Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call.
3 months
Number of patients who have accessed the conditions of use
Délai: 3 months
Number of patients who have accessed the conditions of use
3 months
Change in Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Délai: 3 months
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.
3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
Délai: 3 months
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).
3 months
Professional satisfaction with the mHealth tool assessed by the Net Promoter Score alongside three custom made general satisfaction.
Délai: 3 months
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).
3 months
Patient mHealth tool usability assessed by the System Usability Scale
Délai: 3 months
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.
3 months
Professional mHealth tool usability by the System Usability Scale
Délai: 3 months
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.
3 months
Patient mHealth experience
Délai: 3 months
Two open questions regarding negative and positive aspects of the use of the computer tool
3 months
Professional mHealth experience
Délai: 3 months
Two open questions regarding negative and positive aspects of the use of the computer tool
3 months
Number of clinical diagnoses in app users
Délai: 3 months
number of high priority clinical diagnoses in app users according to CIE10 in medical history
3 months
Degree of severity of the symptom
Délai: 3 months
Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious
3 months
Duration of the symptom
Délai: 3 months
Duration of the symptom expressed in hours, days or weeks
3 months
Number of professionals that the manager has contacted through the app
Délai: 3 months
Number of professionals that the manager has contacted through the app
3 months
Number of interactions between professionals through the app
Délai: 3 months
Number of interactions between professionals through the app
3 months
Number of solutions provided only by the manager
Délai: 3 months
Number of solutions provided only by the manager regarding the number of total solutions
3 months
Number of solutions provided by the primary care professional
Délai: 3 months
Number of solutions provided by the primary care professional regarding the number of total solutions
3 months
Number of solutions that has been a virtual visit
Délai: 3 months
Number of solutions that has been a virtual visit with the primary care professional regarding the total number of solutions
3 months
Number of solutions that has been a classroom visit
Délai: 3 months
Number of solutions that has been a classroom visit with the primary care professional regarding the total number of solutions
3 months
Number of referrals to the emergency department regarding the total number of solutions
Délai: 3 months
Number of referrals to the emergency department regarding the total number of solutions
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Clinic of Barcelona

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 septembre 2019

Achèvement primaire (Réel)

31 décembre 2019

Achèvement de l'étude (Réel)

10 avril 2020

Dates d'inscription aux études

Première soumission

22 juillet 2019

Première soumission répondant aux critères de contrôle qualité

12 août 2019

Première publication (Réel)

14 août 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 février 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 février 2021

Dernière vérification

1 février 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Health-Circuit Clinic

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Données/documents d'étude

  1. Framework
    Identifiant des informations: CONNECARE
    Commentaires d'informations: The ambition of the CONNECARE consortium is to co-design, develop, deploy, and evaluate a novel smart, adaptive integrated care system for chronic care management

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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