CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection

Study Overview
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Brief Summary
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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
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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

Official Title
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CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection Trial

Conditions
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Hand Hygiene, Infection

Intervention / Treatment
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* Device: CleanHands System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single blinded, crossover clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control-then-Intervention<br>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. | Device: CleanHands System<br>* All participants who regularly access the ICUs will wear the CleanHands system wristband while at work for 5 months and the reminding functionality is turned on.<br>|
| Active Comparator: Intervention-then-Control<br>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. This process will last for 5 months. | Device: CleanHands System<br>* All participants who regularly access the ICUs will wear the CleanHands system wristband while at work for 5 months and the reminding functionality is turned on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand hygiene compliance rate | percentage of qualified hand hygiene events divided by total hand hygiene opportunities. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU infection rates | Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), C Diff, Bloodstream MRSA, Surgical Site Infection (SSI), Vancomycin Resistant Enterococcus (VRE), multiple drug resistant pseudomonas, Acinetobacter, Enterobacteriaceae, Carbapenem Resistant Enterobacteriaceae (CRE), and Carbapenem Resistant Organisms (CRO) rates. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand hygiene, infection, sensor