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Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.
Manetti, Stefania; Vainieri, Milena; Guidotti, Elisa; Zuccarino, Sara; Ferré, Francesca; Morelli, Maria Sole; Emdin, Michele.
  • Manetti S; Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy stefania.manetti@santannapisa.it.
  • Vainieri M; Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy.
  • Guidotti E; Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy.
  • Zuccarino S; Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy.
  • Ferré F; Management and Health Laboratory, Institute of Management and EMbeDS Department, Scuola Superiore Sant'Anna, Pisa, Italy.
  • Morelli MS; Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.
  • Emdin M; Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.
BMJ Open ; 10(12): e040738, 2020 12 03.
Article in English | MEDLINE | ID: covidwho-961058
ABSTRACT

INTRODUCTION:

The real-time continuous monitoring of vital parameters in patients affected by multiple chronic conditions and/or COVID-19 can lead to several benefits to the Italian National Healthcare System (IT-NHS). The UBiquitous Integrated CARE (UBICARE) technology is a novel health digital platform at the validation stage in hospital setting. UBICARE might support the urgent need for digitalisation and early intervention, as well as minimise the face-to-face delivery of care in both hospital and community-based care settings. This research protocol aims to design an early-stage assessment of the multidimensional impact induced by UBICARE within the IT-NHS alongside technology validation in a hospital ward. METHODS AND

ANALYSIS:

The targeted patients will be medium/high-risk hypertensive individuals as an illustrative first example of how UBICARE might bring benefits to susceptible patients. A mixed-method study will be applied to incorporate to the validation study a multistakeholder perspective, including perceived patient experiences and preferences, and facilitate technology adoption. First, semistructured interviews will be undertaken with a variety of stakeholders including clinicians, health managers and policy-makers to capture views on the likely technology utility, economic sustainability, impact of adoption in hospital practice and alternative adoption scenarios. Second, a monocentric, non-randomised and non-comparative clinical study, supplemented by the administration of standardised usability questionnaires to patients and health professionals, will validate the use of UBICARE in hospital practice. Finally, the results of the previous stages will be discussed in a multidisciplinary-facilitated workshop with IT-NHS relevant stakeholders to reconcile stakeholders' perspectives. Limitations include a non-random recruitment strategy in the clinical study, small sample size of the key stakeholders and potential stakeholder recruitment bias introduced by the research technique. ETHICS AND DISSEMINATION The Ethics Committee for Clinical Experimentation of Tuscany Region approved the protocol. Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Monitoring, Ambulatory / Early Warning Score Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-040738

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Monitoring, Ambulatory / Early Warning Score Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-040738