Clinical trial NCT03948672: CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection
Official title: CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Hygiene
Infection
Keywords: hand hygiene
infection
sensor
Lead sponsor: Microsensor Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: University of Louisville
name: University of Chicago
name: National Institute on Aging (NIA)
First posted: 2019-05-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single blinded, crossover clinical trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* All nurses, attending physicians, resident physicians, housecleaning staff, medical assistants, respiratory therapists, laboratory personnel (lab drawing) within experiment units.
* At least 18 years old
* Consent to participate in this study

Exclusion Criteria:

* Refusal to participate in this study
* Any reason that makes the participant not able to wear the CleanHands wristband

Primary outcomes:
measure: hand hygiene compliance rate
timeFrame: 12 months
Secondary outcomes:
measure: ICU infection rates
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Health
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jiapeng Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu Q, Liu Y, Cepulis D, Jerde A, Sheppard RA, Reichle W, Scott L, Oppy L, Stevenson G, Bishop S, Clifford SP, Liu P, Kong M, Huang J. Hand hygiene behaviours monitored by an electronic system in the intensive care unit - a prospective observational study. J Hosp Infect. 2022 May;123:126-134. doi: 10.1016/j.jhin.2022.01.017. Epub 2022 Feb 2.