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

NCT06266078 | Not Yet Recruiting

• 1 other identifier: School of Nursing
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Personal Protective Equipment

Keywords

Ergonomics; Personal Protective Equipment; Simulation-Based Research

Outcome Measures

Primary Outcomes (11)

• Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script"

  The experts will assess the documents sent by email and will be instructed to record their opinions, answering in a five-point Likert-type scale ("Strongly agree", "Partially agree", "Neither agree nor disagree", "Partially disagree" and "Strongly disagree") whether they agree or disagree regarding the pertinence, clarity and relevance of each item. The experts' responses will be analyzed and the Content Validity Index (CVI) as well as the Intraclass Correlation Coefficient (ICC) will be calculated.

  During validation phase, the experts will record their answers by email. Up to three consultation rounds will be conducted.

• Errors during PPE assembly/preparation, donning and doffing

  The researcher will observe the participants performing the clinical tasks and will record the following data: * Were there any errors while assembling/preparing the PPE? Yes or No * Did the participant need help while assembling/preparing the PPE? Yes or No * Were there any errors while donning? Yes or No * Did the participant need help while donning? Yes or No * Were there any errors while doffing? Yes or No * Did the participant need help while doffing? Yes or No

  Once for each PPE, while the participant is performing the task in the simulation session

• Communication impairments while using PPE

  The researcher will observe the participants performing the clinical tasks and will record the following data: * Were there any problems with verbal communication related to PPE use? Yes or No * Did the participants have PPE-related hearing difficulties while performing the tasks? Yes or No

  Once for each PPE, while the participant is performing the task in the simulation session

• Self-contamination risk in the professional while using and doffing the PPE

  A fluorescent tracer will be used, which is a transparent dye that only becomes visible when exposed to ultraviolet light. The solution is an abrasion-resistant solution but can be easily removed with a standard cleaning procedure. The tracer will be applied to the PPE used before the start of simulation activities. After the PPE doffing, the researchers will directly visualize the body areas contaminated with the dye, in a dark room, using ultraviolet light and will note this in the data collection tool. The number of contaminated body areas will be considered. The researcher will observe the body areas and will record the following data: \- Did the participant have any of body area contaminated with the dye after doffing? Yes or Not. If yes, register which areas have been contaminated.

  Once for each PPE, after removing it

• Influence of PPE on individual performance

  The researcher will observe the participants performing the clinical tasks and will record the following data: * Were there any errors related to PPE while performing the tasks? Yes or No * Did the participant need PPE-related help while performing the tasks? Yes or No

  Once for each PPE, while the participant is performing the task in the simulation session

• Influence of PPE on team performance and behavioral changes

  The researcher will observe the participants performing the clinical tasks and will record the following data: * Were there any problems related to the assistance provided by the team to the simulated patient? Yes or No * Were there any difficulties related to team performance to meet the objectives proposed? Yes or No

  Once for each PPE, while the participants are performing the task in the simulation session

• Changes in mobility and comfort while using PPE

  The participants will answer the following questions, by filling in a specific form, after finishing the clinical tasks: * Did you notice any innovative PPE-related movement restriction while performing your tasks in the simulation setting? ( ) Frequently; ( ) Sometimes; ( ) No * In relation to comfort and compared to traditional PPE, the innovating PPE is: ( ) More comfortable; ( ) As comfortable as traditional; PPE ( ) Less comfortable

  Once, during the debriefing period, after the participants performing the tasks

• Thermal sensations

  The participants will answer the following question, by filling in a specific form, after finishing the tasks: \- Did you feel heat or other kind of thermal discomfort while performing your tasks using the innovative PPE? ( ) Frequently; ( ) Sometimes; ( ) No

  Once, during the debriefing period, after the participants performing the tasks

• Perception regarding safety and satisfaction of the PPE user

  The participants will answer the following question, by filling in a specific form, after finishing the clinical tasks: * In relation to the safety perception, did you feel completely safe when using the innovative PPE? ( ) Agree; ( ) Indifferent; ( ) Disagree * What was your degree of satisfaction when using the innovative PPE? ( ) Satisfied; ( ) Indifferent; ( ) Unsatisfied

  Once, during the debriefing period, after the participants performing the tasks

• Perceived workload

  It will be used the "NASA Task Load Index" which is an instrument that was developed by Hart and Staveland (1988) and recently translated and validated from English into Brazilian Portuguese. Three of the six dimensions refer to aspects or requirements imposed by the subject (mental, physical and temporal demand) and the other three to the subject-task interaction (performance, effort and frustration).

  Once, during the debriefing period, after the participants performing the tasks

• Usability

  It will be used the System Usability Scale (SUS) which is a five-point Likert-type scale consisting of 10 assertions and which provides an overview of the user's subjective evaluations about usability of a given system, technology or product. For the current study, the instrument used will be a version of the scale translated and validated for Portuguese

  Once, during the debriefing period, after the participants performing the tasks

Secondary Outcomes (1)

• Complementary Content Analysis - qualitative data

  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.

Study Arms (2)

Innovative PPE

EXPERIMENTAL

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

Device: Innovative PPE

Traditional PPE

ACTIVE COMPARATOR

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

Device: Traditional PPE

Interventions

Innovative PPE 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

Also known as: PAPR and Coverall

Innovative PPE

Traditional PPE DEVICE

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

Also known as: N95 Mask + Faceshield and Apron

Traditional PPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Phase 2 - For simulation protocol piloting, NINE participants from each professional category will be included
• 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.
• \- Healthcare workers taking part in simulation studies in the last year, with similar content.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

MeSH Terms

Interventions

N95 Respirators

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Maria Clara Padoveze, PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Caroline L Ciofi-Silva, PhD

CONTACT

+55(19)997091374; clciofi@unicamp.br

Maria Clara Padoveze, PhD

CONTACT

+55(19) 991779272; padoveze@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share