A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)
Primary Purpose
Needle Stick Injuries
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Removal of needle with using ANDYs
Sponsored by
About this trial
This is an interventional other trial for Needle Stick Injuries focused on measuring Efficiency,Usability,Safety
Eligibility Criteria
Inclusion Criteria:
- medical staff of the ER
- adult ER medical staff over 19 years of age
- A subject who voluntarily agrees and signs
Exclusion Criteria:
•A subject who did not agree with this study
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Removal of needle with existing method
Removal of needle with using ANDYs
Arm Description
Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Outcomes
Primary Outcome Measures
Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not
- Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.
Secondary Outcome Measures
Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not
- Comparison of the usability between using the automated needle processing system and not using it by doing survey after 1st week and 3rd week and Interview after 3rd week( Scoring by the answers of the Questionnaire of Satisfaction (SUS) and adjective score)
Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not
- Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04039906
Brief Title
A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)
Official Title
A Single-institutional Study to Assess the Impact of ANDY(Automatic Needle Destroyer) to the Medical Staffs in Terms of Working Efficiency Assessed by Working Time and Satisfaction Assessed by Usability and Safety Using SUS Score and Survey
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.
Detailed Description
Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.
Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.
Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment.
Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system.
Design : RCT (randomized controlled trial)
Setting: EMERGENCY CENTER at the Samsung Medical Center
Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)
Intervention :
6-1) 1st Week : Removal of needle with existing method
Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
Identify the number of syringes processed by existing method.
Do survey after 1st week
6-2) 2nd week: Prepare for using ANDYs
Provide clinicians with instruction how to use ANDY
Install 10 ANDYs in the ER.
6-3) 3rd week : Removal of needle with using ANDYs
Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
Identify the number of syringes processed by ANDY.
After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees feel those are necessary.
Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
Study period : 3 weeks
Satisfaction survey: SUS and adjective score
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needle Stick Injuries
Keywords
Efficiency,Usability,Safety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Removal of needle with existing method
Arm Type
No Intervention
Arm Description
Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Arm Title
Removal of needle with using ANDYs
Arm Type
Experimental
Arm Description
Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Intervention Type
Device
Intervention Name(s)
Removal of needle with using ANDYs
Intervention Description
ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days
Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
Identify the number of syringes processed by ANDY.
After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.
Primary Outcome Measure Information:
Title
Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not
Description
- Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.
Time Frame
[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Secondary Outcome Measure Information:
Title
Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not
Description
- Comparison of the usability between using the automated needle processing system and not using it by doing survey after 1st week and 3rd week and Interview after 3rd week( Scoring by the answers of the Questionnaire of Satisfaction (SUS) and adjective score)
Time Frame
[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Title
Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not
Description
- Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.
Time Frame
[1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medical staff of the ER
adult ER medical staff over 19 years of age
A subject who voluntarily agrees and signs
Exclusion Criteria:
•A subject who did not agree with this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAERIM KIM, Doctoral
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)
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