Clean Hands Accessible and Manageable for Patients (CHAMPs)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCase Western Reserve University

About this trial

This study proposes the novel use of a bedrail-affixed technology-based patient hand hygiene system with verbal and visual reminders to improve hospitalized older adults' self-management of hand hygiene practice, which in return reduces harmful germs found on older adult's hands that lead to infections.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

> 65 years of age,

Admitted to a medical-surgical unit,

Expected to be hospitalized for more than 24 hours,

Written informed consent within 24-48 hours of admission, and

Disqualifiers

terminal illness that prohibit interaction with CHAMPs

behavior disorder

violent behavior

physical or cognitive impairments that prohibit interaction with CHAMPs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clean Hands Accessible and Manageable for Patients

    Behavioral

    Use of a patient-smart hand sanitation dispenser that provides reminders that are non-beeping reminders.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Clean Hands Accessible and Manageable for PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Hand Contamination Presence/Absence with Select Pathogens at Baseline

The primary effect of interest is that of the CHAMPs intervention on hand contamination at day 3-4 of study stay. The research study staff will test the presence/absence of hand contamination using a test of proportions that compares the two study arms using a two-sided test with an α = 0.05. \> 1 colony forming unit of the following organisms susceptible to hand sanitizer: Enterobacteriaceae, Enterococci, Staphylococcus aureus, and Yeastis indicative of presence whereas 0 is indicative of absence. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies\*dilution factor) / volume of culture plate.

Time frame
Day 0
2

Patient Hand Contamination Presence/Absence with Select Pathogens at Day 3-4

The primary effect of interest is that of the CHAMPs intervention on hand contamination at day 3-4 of study stay. The research study staff will test the presence/absence of hand contamination using a test of proportions that compares the two study arms using a two-sided test with an α = 0.05. \> 1 colony forming unit of the following organisms susceptible to hand sanitizer: Enterobacteriaceae, Enterococci, Staphylococcus aureus, and Yeastis indicative of presence whereas 0 is indicative of absence. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies\*dilution factor) / volume of culture plate.

Time frame
Day 3 or 4
3

Patient Hand Contamination Counts of Pathogens at Baseline

The secondary effect retrieved after accomplishing presence or absence is the number of colony forming units (CFU) counts of pathogens. Participants with superior hand hygiene should have less multidrug-resistant organisms on their hands as measured by colony forming units when comparing baseline to the day 3-4 collection of hand swabs. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies\*dilution factor) / volume of culture plate.

Time frame
Day 0
4

Patient Hand Contamination Counts of Pathogens at Day 3-4

The secondary effect retrieved after accomplishing presence or absence is the number of colony forming units (CFU) counts of pathogens. Participants with superior hand hygiene should have less multidrug-resistant organisms on their hands as measured by colony forming units when comparing baseline to the day 3-4 collection of hand swabs. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies\*dilution factor) / volume of culture plate.

Time frame
Day 3 or 4

Secondary outcomes

1

Patient Hand Hygiene Practice at Baseline

Secondary measure of hand hygiene practice will be indicated by hand sanitizer volume used. The bottle of hand sanitizer will be weighed before and after in milligrams (mg). Substracting the end weight from the baseline weight (mg) provides the weight which will then be converted into the difference in volume used. The equivalent of 1 Milligrams (mg) measurement of weight is equivalent to 1 Milliliters (ml) measurement of volume of liquid. The final measurement will be reported in milliliters (ml). Higher use of hand sanitizer volume indicates increased practice.

Time frame
Day 0
2

Patient Hand Hygiene Practice at Day 3-4

Secondary measure of hand hygiene practice will be indicated by hand sanitizer volume used. The bottle of hand sanitizer will be weighed before and after in milligrams (mg). Substracting the end weight from the baseline weight (mg) provides the weight which will then be converted into the difference in volume used. The equivalent of 1 Milligrams (mg) measurement of weight is equivalent to 1 Milliliters (ml) measurement of volume of liquid. The final measurement will be reported in milliliters (ml). Higher use of hand sanitizer volume indicates increased practice.

Time frame
Day 3 or 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Western Reserve University

Lead sponsor

Louis Stokes VA Medical Center

Collaborator

MetroHealth Medical Center

Collaborator