Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03948672 |
| Other study ID # |
19.001 |
| Secondary ID |
4R44AG060848-02 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2020 |
| Est. completion date |
August 29, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Microsensor Labs LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine if use of the CleanHands system can improve hand
hygiene/personal protective equipment (PPE) compliance and reduce infections in the hospital
ICUs through reminders to wash hands and use PPE as appropriate.
Description:
Experimental design: The investigators plan to perform a randomized cross-over study at
University of Louisville Hospital (ULH) ICUs from July 2019 to June 2020. The study will be
submitted to the University of Louisville IRB for approval before any study activities are
started.
Performance Site: University of Louisville Hospital. The ICU departments will be randomized
to participate in either one of the two research arms: control-then-intervention arm or
intervention-then-control arm.
Participants: All nurses, attending physicians, resident physicians, housecleaning staff,
medical assistants, respiratory therapists, laboratory personnel (lab drawing) within
experiment units.
Control-then-Intervention arm: In each intensive care unit assigned to the
Control-then-Intervention arm, all participants who regularly access the ICUs will wear the
wristband while at work for 5 months. The functionality of the wristband will not be
disclosed to the healthcare providers. Handwashing compliance data will be automatically
collected, but data will not be shared with the healthcare providers or hospital management
teams. After 5 months, a washout period of 2 months will be introduced to eliminate potential
influences on healthcare providers' behaviors from the sensor system. Then, all healthcare
providers will be educated on the functionalities of the CleanHands system with real time
reminders now turned on. Healthcare providers will then have access to their own and
unit-specific handwashing data. The unit manager and hospital administrators will be able to
access all of these data and advanced analysis to make management decisions on infection
reduction. This phase will last for 5 months. All personnel will be educated not to discuss
the functionalities of CleanHands system with their co-workers to ensure adequate blinding.
Intervention-then-Control arm: In each intensive care unit assigned to the
Intervention-then-Control arm, all participants who regularly access to the ICUs will be
educated on the functionalities of the CleanHands system with real time reminders turned on.
Healthcare providers will then have access to their own and unit-specific handwashing data.
The unit manager and hospital administrators will be able to access all of these data and
advanced analysis to make management decisions on infection control. This phase will last for
5 months. After 5 months, a washout period of 2 months will be introduced to eliminate
potential influences on healthcare providers' behaviors from sensor system installation and
implementation. Then, the real-time reminder functionality of the wristband will be turned
off and no more education will be provided. Handwashing compliance data will be automatically
collected but will not be shared with the healthcare providers. The unit manager and hospital
administrators will now be blinded to the handwashing compliance results. This process will
last for 5 months.
Data collection: Handwashing compliance data are automatically collected by CleanHands. These
data include all handwashing opportunities (defined as when a wristband is in pre-set
proximity of the controller for 5 seconds or more), total cleaning solution dispensing
counts, rates of
