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

Chronic Disease Clinical Trial

— Health_Circuit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056663
• Other study ID #: Health-Circuit Clinic
• Status: Completed
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: February 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 10, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Multiple Chronic Conditions

Intervention

Behavioral:
• Health-Circuit mobile application
Health-Circuit as a collaborative tool between professionals and patient and professionals

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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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 Mölken 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. — View Citation

Lupiáñez-Villanueva F, Anastasiadou D, Codagnone C, Nuño-Solinís 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. — View Citation

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. Review. — View Citation

Ramírez-Vélez 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. Spanish. — View Citation

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

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. — View Citation

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. Erratum in: JMIR Res Protoc. 2016 Oct 13;5(4):e194. — View Citation

Tistad M, Lundell S, Wiklund M, Nyberg A, Holmner Å, 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. — View Citation

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 — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned visits	Number of unplanned primary care and hospital visits	3 months
Secondary	Service utilization measures	number of primary care and hospital visits, number of remote resolutions and number of hospitalizations	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Equipment failures	Number of equipment failures according to blockage, breakage, acceleration or delay and unidentified failures	3 months
Secondary	Software failures	Number of software failures described as slowdown in execution, information delay, command rows or information not available	3 months
Secondary	Errors in execution	Number of errors in execution (wrong sequence action) described as omission, forward jump, backward jump, repetition, inversion or incorrect action	3 months
Secondary	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	3 months
Secondary	Errors due to failures in the organization	Number of errors due to failures in the organization described as anthropometric problems or inadequate interface	3 months
Secondary	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	3 months
Secondary	Number of entries to the application (app) per patient	Number of entries to the application (app) per patient	3 months
Secondary	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	3 months
Secondary	Number of video calls	Number of video calls i. Number of total video calls. ii. Number of patients who have contacted via video call.	3 months
Secondary	Number of patients who have accessed the conditions of use	Number of patients who have accessed the conditions of use	3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Patient mHealth experience	Two open questions regarding negative and positive aspects of the use of the computer tool	3 months
Secondary	Professional mHealth experience	Two open questions regarding negative and positive aspects of the use of the computer tool	3 months
Secondary	Number of clinical diagnoses in app users	number of high priority clinical diagnoses in app users according to CIE10 in medical history	3 months
Secondary	Degree of severity of the symptom	Degree of severity of the symptom measured according to very mild, mild, neutral, severe or very serious	3 months
Secondary	Duration of the symptom	Duration of the symptom expressed in hours, days or weeks	3 months
Secondary	Number of professionals that the manager has contacted through the app	Number of professionals that the manager has contacted through the app	3 months
Secondary	Number of interactions between professionals through the app	Number of interactions between professionals through the app	3 months
Secondary	Number of solutions provided only by the manager	Number of solutions provided only by the manager regarding the number of total solutions	3 months
Secondary	Number of solutions provided by the primary care professional	Number of solutions provided by the primary care professional regarding the number of total solutions	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months

External Links

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