Clean Hands Accessible and Manageable for Patients (CHAMPs) (CHAMPs)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Patient Participation; Pathogen Transmission
• Intervention / Treatment: Behavioral: Clean Hands Accessible and Manageable for Patients

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanina C Knighton, PhD; Phone Number: 2167987794; Email: sck46@case.edu
• Study Contact Backup: Name: Curtis Donskey, MD; Phone Number: 216-791-3800; Email: Curtis.Donskey@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • MetroHealth Medical Center
      • Contact: Amy Ray, MD; Phone Number: 216-778-5709; Email: Aray2@metrohealth.org
      • Principal Investigator: Amy Ray, MD
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Lous Stokes Cleveland VA Medical Center
      • Contact: Curtis Donskey, MD; Phone Number: 216-791-3800; Email: curtis.donskey@v.gov
      • Contact: Jennifer Cadnum, BA; Phone Number: 2167913800; Email: Jennifer.Cadnum@va.gov
      • Principal Investigator: Curtis Donskey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. > 65 years of age,
2. Admitted to a medical-surgical unit,
3. Expected to be hospitalized for more than 24 hours,
4. Written informed consent within 24-48 hours of admission, and
5. Speak and read English
6. Physical capacity to use the CHAMPs system
7. Sufficient hearing and seeing capacity to indicate understanding and use of the intervention.

Exclusion Criteria

1. terminal illness that prohibit interaction with CHAMPs
2. behavior disorder
3. violent behavior
4. physical or cognitive impairments that prohibit interaction with CHAMPs
5. limiting understanding and use of CHAMPs
6. undergoing radiation or chemotherapy that prohibit interaction with CHAMPs
7. skin disorders or
8. broken skin on hands.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Experimental: Clean Hands Accessible and Manageable for Patients; 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.	Behavioral: Clean Hands Accessible and Manageable for Patients; Use of a patient-smart hand sanitation dispenser that provides reminders that are non-beeping reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0
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.	Day 3 or 4
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.	Day 0
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.	Day 3 or 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0
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.	Day 3 or 4

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: Louis Stokes VA Medical Center; MetroHealth Medical Center
• Investigators: Principal Investigator: Shanina C Knighton, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: self-management; older adult; patient hand hygiene; infection prevention and control
• Other Study ID Numbers: R01AG078273 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No