Clinical trial NCT06266078: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment
Official title: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Personal Protective Equipment
Keywords: Ergonomics
Personal Protective Equipment
Simulation-Based Research
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Firstly, a minimum of 14 experts will validate the content, using the Delphi technique of two tools (A) The innovative PPE assessment tool; and B) the simulation scenario script.

After reaching consensus among the experts, the protocol will be piloted. Two identical sessions will be conducted using the cross-over method with all participants, so that the same participant performs the tasks using the innovative PPE and the comparative PPE, allowing the participants compare characteristics of both PPE. The PPE use sequence and the PPE type will be randomized to minimize biases. Between both sessions there will a 30-minute break for the participants.

For the purpose of the development and piloting of this simulation protocol, the innovative PPE were selected according to compliance with the specifications required by the World Health Organization. It will enrolled 36 healthcare workers in piloting test.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: The study design is a methodological study with a quantitative approach, consisting of two phases. In phase 1 we will perform a virtual development and content validation by experts, of an innovative PPE assessment simulation. In phase 2 we will pilot the simulation protocol. Phase 2 will be conducted in the simulation center of the School of Nursing, University of São Paulo.

Phase 1 - For content validation, a minimum of 14 experts will be included \[21\]. The experts shall have experience in the themes of infection prevention and control (IPC) and simulation studies to validate the data collection tool. Considering that the intention is for the simulation protocol to be applicable in different countries, experts working in Brazil and in foreign countries will be included. The experts must be fluent in the Portuguese or English languages, have a minimum degree of specialization in the health areas, and have academic experience, as evidenced by publications in indexed scientific journals over the last three years. The search for experts working in Brazil will be performed through a platform of the researchers' resumes, available on the National Council for Scientific and Technological Development (CNPq) portal, as well as in reference lists of scientific papers on the theme. Experts working in other countries will also be selected through the reference list of scientific papers and after analyzing the information recorded in the Open Researcher and Contributor platform: ID (ORCID).

Phase 2 - The simulation protocol piloting will include HCW with work experience in critical care (intensive care units and emergency department) for adult patients, from the following professional categories: physicians, nurses, nursing technicians and physiotherapists, with at least one year of experience, and regardless of gender. Professionals taking part in simulation studies in the last year, with similar content, will be excluded. The convenience sample will be invited by word of mouth and by means of posters in selected hospitals in São Paulo.

After reaching consensus regarding the clinical simulation script among the experts, the protocol will be piloted. After accepting to take part in the research by signing a written consent form, the participants will be emailed informational materials about the activities that will be performed and instructional material about the PPE items that will be used.

Two identical sessions will be conducted using the cross-over method with all participants, so that the same participant performs the tasks using the innovative PPE and the comparative PPE, allowing the participants compare characteristics of both PPE. The PPE use sequence and the PPE type will be randomized to minimize biases. Between both sessions there will a 30-minute break for the participants.

Eligibility criteria: 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.

Primary outcomes:
measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script"
timeFrame: During validation phase, the experts will record their answers by email. Up to three consultation rounds will be conducted.
measure: Errors during PPE assembly/preparation, donning and doffing
timeFrame: Once for each PPE, while the participant is performing the task in the simulation session
measure: Communication impairments while using PPE
timeFrame: Once for each PPE, while the participant is performing the task in the simulation session
measure: Self-contamination risk in the professional while using and doffing the PPE
timeFrame: Once for each PPE, after removing it
measure: Influence of PPE on individual performance
timeFrame: Once for each PPE, while the participant is performing the task in the simulation session
measure: Influence of PPE on team performance and behavioral changes
timeFrame: Once for each PPE, while the participants are performing the task in the simulation session
measure: Changes in mobility and comfort while using PPE
timeFrame: Once, during the debriefing period, after the participants performing the tasks
measure: Thermal sensations
timeFrame: Once, during the debriefing period, after the participants performing the tasks
measure: Perception regarding safety and satisfaction of the PPE user
timeFrame: Once, during the debriefing period, after the participants performing the tasks
measure: Perceived workload
timeFrame: Once, during the debriefing period, after the participants performing the tasks
measure: Usability
timeFrame: Once, during the debriefing period, after the participants performing the tasks
Secondary outcomes:
measure: Complementary Content Analysis - qualitative data
timeFrame: Two focus group meetings will be held, one with the Brazilian experts and another with the international experts, up to a month after the end of the pilot test.
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Maria Clara Padoveze, PhD
role: STUDY_CHAIR
References: