A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Personal Protective Equipment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Innovative PPE

The healthcare workers will perform tasks using non-traditional personal protective equipments.

Group Type EXPERIMENTAL

Innovative PPE

Intervention Type DEVICE

The healthcare workers will perform tasks using innovative personal protective equipments, such as LightWeight Powered Air-Purifying Respirator (PAPR) or other type of PAPR and a Sealed coverall

Traditional PPE

The healthcare workers will perform tasks using traditional personal protective equipments.

Group Type ACTIVE_COMPARATOR

Traditional PPE

Intervention Type DEVICE

The healthcare workers will perform tasks using usual personal protective equipments, such as N95 mask plus Faceshield and waterproof apron.

Interventions

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Innovative PPE

The healthcare workers will perform tasks using innovative personal protective equipments, such as LightWeight Powered Air-Purifying Respirator (PAPR) or other type of PAPR and a Sealed coverall

Intervention Type DEVICE

Traditional PPE

The healthcare workers will perform tasks using usual personal protective equipments, such as N95 mask plus Faceshield and waterproof apron.

Intervention Type DEVICE

Other Intervention Names

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PAPR and Coverall N95 Mask + Faceshield and Apron

Eligibility Criteria

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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.

* 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

Phase 2 - For simulation protocol piloting, NINE participants from each professional category will be included

\- Healthcare workers taking part in simulation studies in the last year, with similar content.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes