CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection

NCT03948672 | Completed DMC

• 2 other identifiers: 19.0014R44AG060848-02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Hygiene; Infection

Keywords

hand hygiene; infection; sensor

Outcome Measures

Primary Outcomes (1)

• hand hygiene compliance rate

  percentage of qualified hand hygiene events divided by total hand hygiene opportunities.

  12 months

Secondary Outcomes (1)

• ICU infection rates

  12 months

Study Arms (2)

Control-then-Intervention

ACTIVE COMPARATOR

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

Intervention-then-Control

ACTIVE COMPARATOR

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

Interventions

CleanHands System DEVICE

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.

Control-then-Intervention; Intervention-then-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Microsensor Labs LLC: lead
• National Institutes of Health (NIH): collaborator
• University of Louisville: collaborator
• University of Chicago: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Louisville Health

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• 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.

  PMID: 35122887 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Jiapeng Huang, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single blinded, crossover clinical trial

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: October 7, 2020
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)