A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment
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Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers.

Eligibility:
- EligibilityCriteria: Phase 1 - For content validation, a minimum of 14 experts will be included.  Inclusion criteria:  Have experience in the themes of infection prevention and control (IPC) and simulation studies; Work in Brazil and in foreign countries; Be fluent in the Portuguese or English languages; Have a minimum degree of specialization in the health areas; Have academic experience, as evidenced by publications in indexed scientific journals over the last three years.  Exclusion criteria - None  Phase 2 - For simulation protocol piloting, NINE participants from each professional category will be included  Inclusion Criteria  Healthcare workers with experience in critical care (intensive care units and emergency department) for adult patients; Working as physicians, nurses, nursing technicians and physiotherapists, regardless of gender; With at least one year of experience.  Exclusion Criteria:  - Healthcare workers taking part in simulation studies in the last year, with similar content. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult