Clinical trial NCT05866393: Clean Hands Accessible and Manageable for Patients (CHAMPs)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pathogen Transmission
Patient Participation
Aging
Keywords: patient hand hygiene
self-management
infection prevention and control
older adult
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Louis Stokes VA Medical Center
name: MetroHealth Medical Center
First posted: 2023-05-19
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Hand Contamination Presence/Absence with Select Pathogens at Baseline
timeFrame: Day 0
measure: Patient Hand Contamination Presence/Absence with Select Pathogens at Day 3-4
timeFrame: Day 3 or 4
measure: Patient Hand Contamination Counts of Pathogens at Baseline
timeFrame: Day 0
measure: Patient Hand Contamination Counts of Pathogens at Day 3-4
timeFrame: Day 3 or 4
Secondary outcomes:
measure: Patient Hand Hygiene Practice at Baseline
timeFrame: Day 0
measure: Patient Hand Hygiene Practice at Day 3-4
timeFrame: Day 3 or 4
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Lous Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Shanina C Knighton, PhD
role: PRINCIPAL_INVESTIGATOR
References: