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.

Clean Hands Accessible and Manageable for Patients (CHAMPs)

Pathogen Transmission

Patient Participation

Aging

The investigators long-term goal to establish sustainable, patient-centered interventions at
      the patient level to engage patients in safety and prevention by offsetting barriers such as
      physical and sensory limitations that prohibit older adults from actively cleaning their
      hands independently. Unfortunately, older adults are at highest risk for infections and yet
      while hand hygiene is the single most important way to prevent the spread of infection,
      mechanisms for older adults to minimize personal risk for infections is often overlooked.
      Many contamination elements exist in hospital settings and for older adults encountering
      high-touch surfaces and medical devices that harbor pathogens that lead to infections will
      occur. However, without assistance, hand-hygiene practice rates are poor among hospitalized
      older adults' due to frailty, limited dexterity and mobility, cognitive limitations, and risk
      of falling, which prohibits independent use of visible hand- hygiene products (e.g., wall
      dispensers, towelettes, in-room sinks). New solutions are necessary. Therefore, in this
      proposal, the investigators have updated this investigator-developed, technology-enhanced
      patient hand hygiene system. Clean Hands Accessible and Manageable for Patients (CHAMPs), the
      investigator-developed and pilot tested bed rail-affixed hand-sanitizing dispenser, which
      features verbal, auditory and visual reminders to remind patients to sanitize hands. The safe
      and easily accessible motion-sensing system with usage tracking requires very little physical
      effort, as users need only to be able to freely move upper extremities and reach over to the
      bed rail to clean hands when prompted (e.g. before meal times). Pilot results among both a
      small group of older adults and in a high-tech simulated environment demonstrated both
      efficacy and feasibility of the intervention. In this 4-year project, the investigators
      propose a large heterogeneous randomized controlled trial (RCT) comparing two groups of
      hospitalized adults ≥ 65 years in two public hospitals, one group receives CHAMPs (n=125) and
      the other is the usual-care (UC) group (n=125). Study investigators consists of early and
      late stage investigators who have a successful record of working together and are ready to
      address the following aims: (1) to determine the effect of CHAMPs as a method to improve hand
      hygiene behavior and reduce patients' hand contamination, (2) assess the implementation of
      the intervention and (3) examine factors that influence outcomes associated with the
      intervention. The primary outcome is hand contamination as measured by presence, type, and
      quantity of colony forming units located on participants' hands. The research study staff's
      preliminary results offer promise that the CHAMPs technology-enhanced intervention may be an
      effective approach to engage patients in infection prevention as a solution to reduce
      colonization and infection rates among older adults.This proposal aligns with all four goals
      of NIH/NIA's 2020-2025 strategic plan, which is to improve the health, well-being, and
      independence of adults as age increases and to prevent or reduce the burden of age-related
      diseases, disorders, and disabilities.

Clean Hands Accessible and Manageable for Patients

Clean Hands Accessible and Manageable for Patients (CHAMPs): A Technology-based Self-management Intervention to Improve Patient Hand Hygiene and Reduce Hand Contamination Among Older Adults

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.

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.

Research Associate Professor

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.

Based on the literature reviewed and previous studies, the enrollment and the control group (Group 1- Usual Care) will begin within 24 hours of participants' admission to medical surgical units (4A, 4B, 5A, 5B- Cleveland VA and 9B, 9C, 11C, 7A MetroHealth). Data collection times are: the day of admission (Baseline, Day 0-1) and Day 3-4 between 2pm and 5pm. Participants will be consented for the research study staff to collect swabs for their nares on Day 0-1 and Day 3-4 and their hands at admission Day 0-1 and Day 3-4. No education or hand hygiene products will be provided. It is established that at both institutions a lemon towelette packet is provided with each meal.

CHAMPs participants will receive a patient hand-sanitation system attached via an R-shape clip to the bed rail. After it is placed on the bed rail, the personalized verbal electronic audio reminder with the RA's voice to insert the participants' name, " ____ it is (breakfast, lunch, dinner) time, please clean your hands." The times will be within an hour window of 7 a.m., noon, and 5 p.m. The CHAMPs system will be labeled "For Patient Use Only." The times were chosen around meal times because these times also are similar to around the time when medications are being administered. The hands can be a vector for germs to the face and mouth as shown in the literature. On Day 3 or 4 whichever comes later without anticipated discharge, the Interventionist will provide the evaluation of intervention questionnaires, clean the system turn it in to the project manager to retrieve SD card which contains the month, day, time, and number of system usages.

Clean Hands Accessible and Manageable for Patients (CHAMPs)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status