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

November 13, 2022 updated by: Microsensor Labs LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand hygiene compliance rate
Time Frame: 12 months
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
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microsensor Labs LLC

Collaborators

University of Chicago
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

August 29, 2022

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.001
  • 4R44AG060848-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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