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

NCT04056663 | Completed

• 1 other identifier: Health-Circuit Clinic
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Chronic Conditions; Chronic Disease

Keywords

Artificial Intelligence; Continuity of Patient Care

Outcome Measures

Primary Outcomes (1)

• Unplanned visits

  Number of unplanned primary care and hospital visits

  3 months

Secondary Outcomes (30)

• Service utilization measures

  3 months

• Change in The Health Empowerment Scale

  3 months

• Change in the Fantastic Lifestyle questionnaire

  3 months

• Equipment failures

  3 months

• Software failures

  3 months

Study Arms (2)

Health-Circuit mobile application

EXPERIMENTAL

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.

Behavioral: Health-Circuit mobile application

Conventional treatment

NO INTERVENTION

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.

Interventions

Health-Circuit mobile application BEHAVIORAL

Health-Circuit as a collaborative tool between professionals and patient and professionals

Health-Circuit mobile application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

Location

Related Publications (13)

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  PMID: 17339106 BACKGROUND

• Tistad M, Lundell S, Wiklund M, Nyberg A, Holmner A, Wadell K. Usefulness and Relevance of an eHealth Tool in Supporting the Self-Management of Chronic Obstructive Pulmonary Disease: Explorative Qualitative Study of a Cocreative Process. JMIR Hum Factors. 2018 Oct 26;5(4):e10801. doi: 10.2196/10801.

  PMID: 30368440 BACKGROUND

• Lupianez-Villanueva F, Anastasiadou D, Codagnone C, Nuno-Solinis R, Garcia-Zapirain Soto MB. Electronic Health Use in the European Union and the Effect of Multimorbidity: Cross-Sectional Survey. J Med Internet Res. 2018 May 3;20(5):e165. doi: 10.2196/jmir.7299.

  PMID: 29724702 BACKGROUND

• Wildenbos GA, Maasri K, Jaspers M, Peute L. Older adults using a patient portal: registration and experiences, one year after implementation. Digit Health. 2018 Sep 2;4:2055207618797883. doi: 10.1177/2055207618797883. eCollection 2018 Jan-Dec.

  PMID: 30186619 BACKGROUND

• Steele Gray C, Wodchis WP, Upshur R, Cott C, McKinstry B, Mercer S, Palen TE, Ramsay T, Thavorn K; Project Collaborators And Technology Partner, QoC Health Inc. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool. JMIR Res Protoc. 2016 Jun 24;5(2):e126. doi: 10.2196/resprot.5756.

  PMID: 27341765 BACKGROUND

• Matui P, Wyatt JC, Pinnock H, Sheikh A, McLean S. Computer decision support systems for asthma: a systematic review. NPJ Prim Care Respir Med. 2014 May 20;24:14005. doi: 10.1038/npjpcrm.2014.5.

  PMID: 24841952 BACKGROUND

• Leijten FRM, Struckmann V, van Ginneken E, Czypionka T, Kraus M, Reiss M, Tsiachristas A, Boland M, de Bont A, Bal R, Busse R, Rutten-van Molken M; SELFIE consortium. The SELFIE framework for integrated care for multi-morbidity: Development and description. Health Policy. 2018 Jan;122(1):12-22. doi: 10.1016/j.healthpol.2017.06.002. Epub 2017 Jun 20.

  PMID: 28668222 BACKGROUND

• Vázquez R, Martínez M. Ministerio de Industria, Energía y Turismo Entidad Pública Empresarial Red.es Observatorio Nacional de las Telecomunicaciones y de la Sociedad de la Información [Internet]. 2016. p. 0-200. Available from: https://www.ontsi.red.es/ontsi/sites/ontsi/files/los_ciudadanos_ante_la_e-sanidad.pdf

  BACKGROUND

• Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.

  PMID: 14712543 BACKGROUND

• Ramirez-Velez R, Agredo RA. [The Fantastic instrument's validity and reliability for measuring Colombian adults' life-style]. Rev Salud Publica (Bogota). 2012 Mar-Apr;14(2):226-37. doi: 10.1590/s0124-00642012000200004. Spanish.

  PMID: 23250366 RESULT

• Serrani Azcurra DJ. Elders Health Empowerment Scale: Spanish adaptation and psychometric analysis. Colomb Med (Cali). 2014 Dec 30;45(4):179-85. eCollection 2014 Oct-Dec.

  PMID: 25767307 RESULT

• Uijen AA, Schellevis FG, van den Bosch WJ, Mokkink HG, van Weel C, Schers HJ. Nijmegen Continuity Questionnaire: development and testing of a questionnaire that measures continuity of care. J Clin Epidemiol. 2011 Dec;64(12):1391-9. doi: 10.1016/j.jclinepi.2011.03.006.

  PMID: 21689904 RESULT

• Herranz C, Martin-Moreno Banegas L, Dana Muzzio F, Siso-Almirall A, Roca J, Cano I. A Practice-Proven Adaptive Case Management Approach for Innovative Health Care Services (Health Circuit): Cluster Randomized Clinical Pilot and Descriptive Observational Study. J Med Internet Res. 2023 Jun 14;25:e47672. doi: 10.2196/47672.

  PMID: 37314850 DERIVED

Related Links

• Digital tool
• Measuring Usability With The System Usability Scale (SUS). Measuring Usability

MeSH Terms

Conditions

Multiple Chronic Conditions; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 14, 2019
• Study Start: September 12, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 10, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)