Clean Hands Accessible and Manageable for Patients (CHAMPs)

NCT05866393 | Recruiting

• 1 other identifier: R01AG078273
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pathogen Transmission; Patient Participation; Aging

Keywords

patient hand hygiene; self-management; infection prevention and control; older adult

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Patient Hand Hygiene Practice at Baseline

  Day 0

• Patient Hand Hygiene Practice at Day 3-4

  Day 3 or 4

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Clean Hands Accessible and Manageable for Patients

EXPERIMENTAL

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

Interventions

Clean Hands Accessible and Manageable for Patients BEHAVIORAL

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

Clean Hands Accessible and Manageable for Patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \> 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
• Speak and read English
• Physical capacity to use the CHAMPs system
• Sufficient hearing and seeing capacity to indicate understanding and use of the intervention.

You may not qualify if:

• terminal illness that prohibit interaction with CHAMPs
• behavior disorder
• violent behavior
• physical or cognitive impairments that prohibit interaction with CHAMPs
• limiting understanding and use of CHAMPs
• undergoing radiation or chemotherapy that prohibit interaction with CHAMPs
• skin disorders or
• broken skin on hands.

Sponsors & Collaborators

• Case Western Reserve University: lead
• Louis Stokes VA Medical Center: collaborator
• MetroHealth Medical Center: collaborator

Study Sites (2)

Lous Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Shanina C Knighton, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanina C Knighton, PhD

CONTACT

2167987794; sck46@case.edu

Curtis Donskey, MD

CONTACT

216-791-3800; Curtis.Donskey@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Using the randomization software the investigators will know who is in the CHAMPs or UC groups and will then assign the newly enrolled participant to an interventionist at each site. The randomization software will assign 0's and 1's. The 1's will indicate who is in the intervention group. For those assigned to CHAMPs, the interventionist after baseline data is collected will go in to set up the participants for the intervention which entails the CHAMPs system being placed on the bedrail and participants shown how it works and a patient return demonstration of use.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: In this 4-year project, the investigators will conduct a two-group parallel-design, RCT to determine the efficacy of a novel technology-based patient hand-hygiene system (CHAMPs) as a method to improve hand-hygiene behavior and reduce patients' hand contamination (Aim 1).

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 19, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)