Detection of Usability Errors of a Medical Device Zeneo®

The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: using the demo version of a self-injector pen

Detailed Description

In order to determine how many participants must be recruited to detect 95% of the anticipated use errors, two groups of participants (naives or informed to the type of device under evaluation) will take part to usability test of a demo version of an auto injector pen in one of two test environments (realistic or laboratory-like). The combination of the 2 types of users and the two types of environment composes 4 arms.

By default, 15 participants will be recruited per arm (in conformity with usual guidelines). If, in a given group, 95% of anticipated errors are detected, no more participants will be recruited in the arm. Otherwise, 5 other participants will be recruited till the 95% threshold is reached with a maximum of 40 participants per group.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haut De France
    • Lille, Haut De France, France, 59037
      • Usability Lab of CIC IT 1403

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Two types of participants (healthy people) will be recruited: participants informed about auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.

Inclusion Criteria:

• Able to use the device
• Without previous experience of anaphylactic shock
• Not taking a psychotropic drug
• Without hearing impairment
• Covered by social security
• Who signed the consent form and the information letter
• Who agree to conform to the procedure of the study -

Exclusion Criteria:

• Pregnant women
• Vulnerable Persons
• Persons under administrative supervision
• Persons who are subject to a judicial protection measure
• Persons who do not understand correctly French.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: naive/realistic environment; This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen".	Other: using the demo version of a self-injector pen; Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
Experimental: informed/realistic environment; This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen".	Other: using the demo version of a self-injector pen; Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
Experimental: informed/laboratory-like environment; This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen".	Other: using the demo version of a self-injector pen; Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
Experimental: naive/laboratory-like environment; This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen".	Other: using the demo version of a self-injector pen; Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For each arm, number of participants needed to uncover 95% of the use errors known	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of use errors uncovered per participant	through study completion, an average of 6 months
number of participants who detected a given error	through study completion, an average of 6 months
number of unanticipated errors detected	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: National Research Agency, France
• Investigators: Principal Investigator: Romaric Marcilly, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017_16; 2017-A02847-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No