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CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection (SHHRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948672
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : April 3, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Louisville
University of Chicago
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Microsensor Labs LLC

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.

Condition or disease Intervention/treatment Phase
Hand Hygiene Infection Device: CleanHands System Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, single blinded, crossover clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection Trial
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control-then-Intervention
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
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.

Active Comparator: Intervention-then-Control
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
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.




Primary Outcome Measures :
  1. hand hygiene compliance rate [ Time Frame: 12 months ]
    percentage of qualified hand hygiene events divided by total hand hygiene opportunities.


Secondary Outcome Measures :
  1. ICU infection rates [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948672


Contacts
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Contact: Jiapeng Huang, MD, PhD 5024321582 j0huan03@louisville.edu
Contact: Maiying Kong, PhD 5022964930 maiying.kong@louisville.edu

Sponsors and Collaborators
Microsensor Labs LLC
National Institutes of Health (NIH)
University of Louisville
University of Chicago
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jiapeng Huang, MD, PhD University of Louisville
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Responsible Party: Microsensor Labs LLC
ClinicalTrials.gov Identifier: NCT03948672    
Other Study ID Numbers: 19.001
4R44AG060848-02 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Microsensor Labs LLC:
hand hygiene
infection
sensor
Additional relevant MeSH terms:
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Infection
Communicable Diseases