Hand Hygiene Reminders to Reduce Infections in Aging Patients

(CHAMPs Trial)

Recruiting at 1 trial location

Overseen By Curtis Donskey, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Terminal illness, Behavior disorder, Violent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special hand hygiene system, Clean Hands Accessible and Manageable for Patients (CHAMPs), can reduce infections in older adults in the hospital. The system attaches to a bedrail and uses audio cues to remind patients to clean their hands around meal times. Participants will either use this new system or receive the usual care for comparison. This trial may suit patients over 65 who can hear and see well enough to use the system and are staying in the hospital for more than a day. As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve hospital care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this hand hygiene system is safe for aging patients?

Research shows that the Clean Hands Accessible and Manageable for Patients (CHAMPs) system offers a new method to help older adults maintain hand cleanliness. Studies have found that this system uses sounds and visuals to remind individuals to wash their hands, aiming to enhance hand hygiene. Although the system remains under testing, no harm has been reported from its use. Since it prompts hand cleaning rather than involving medication, the risk of side effects is expected to be low. However, following the trial's guidelines is crucial to ensure safety with any new technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to improving hand hygiene among aging patients, which is crucial in reducing infections. Unlike standard care options that often rely on patients' awareness and adherence to hand hygiene, this trial introduces an innovative system called CHAMPs. This system uses personalized verbal reminders attached to the bed rail to prompt patients to clean their hands around meal times, leveraging a new, proactive method to encourage hygiene. By directly integrating reminders into patients’ routines, the trial aims to enhance compliance and potentially reduce infection rates more effectively than traditional methods.

What evidence suggests that this hand hygiene system is effective for reducing infections in aging patients?

Research shows that better hand hygiene can greatly reduce the spread of germs and infections. This trial tests the Clean Hands Accessible and Manageable for Patients (CHAMPs) system as an intervention to encourage regular hand cleaning. Studies have found that systems like CHAMPs help people remember to wash their hands more often, especially in hospitals. By placing hand sanitizer on the bedrail and providing verbal reminders, patients are more likely to maintain clean hands. This method has been linked to fewer infections by preventing the spread of germs. Early results suggest that using such systems can noticeably improve patient health. ^{1 2 3 4 5}

Who Is on the Research Team?

Shanina C Knighton, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

The CHAMPs trial is for hospitalized older adults over 65 who are staying in a medical-surgical unit for more than a day. Participants must be able to speak and read English, give written consent shortly after admission, and have the physical ability as well as sufficient hearing and vision to use the hand hygiene system.

Inclusion Criteria

I am 65 years old or older.

I am admitted to a hospital's medical-surgical unit.

Expected to be hospitalized for more than 24 hours

Exclusion Criteria

Terminal illness

I do not have any physical or mental conditions that prevent me from understanding and using CHAMPs.

I am currently receiving radiation or chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Initial assessment of hand contamination and hand hygiene practice

1 day

1 visit (in-person)

Intervention

Participants receive the CHAMPs hand hygiene system with verbal and visual reminders

3-4 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for hand contamination and hand hygiene practice after intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clean Hands Accessible and Manageable for Patients

Trial Overview This study tests a new bedrail-affixed technology that reminds patients through verbal and visual cues to practice hand hygiene. It aims to see if this can help reduce germ transmission by improving self-managed hand cleaning practices among older hospital patients.

How Is the Trial Designed?

Group I: Clean Hands Accessible and Manageable for Patients Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

Louis Stokes VA Medical Center

Collaborator

Trials

21

Recruited

4,100+

Published Research Related to This Trial

The implementation of an automated hand hygiene reminder system (AHHRS) significantly increased the number of hand hygiene observations from 2,642 to 265,505, demonstrating its effectiveness in promoting adherence among healthcare workers.

Hand hygiene adherence improved from 86.47% to 89.68% in the medical-surgical unit and from 85.93% to 91.24% in the medical intensive care unit, while potential cross-contamination events decreased significantly, indicating that AHHRS not only enhanced compliance but also contributed to safer patient environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand hygiene behavior change: a review and pilot study of an automated hand hygiene reminder system implementation in a public hospital. Seferi, A., Parginos, K., Jean, W., et al.[2023]

The implementation of an automated hand hygiene monitoring system (AHHMS) significantly improved hand hygiene performance rates in both acute-care and long-term care units, with rates increasing from a median of 18.6% at baseline to 25.1% after one year of intervention.

Acute-care units showed a greater improvement in hand hygiene compliance compared to long-term care units, indicating that the environment and patient mobility may influence hand hygiene practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a prospective intervention program with automated monitoring of hand hygiene performance in long-term and acute-care units at a Veterans Affairs medical center. Starrett, WG., Arbogast, JW., Parker, AE., et al.[2023]

The automated hand hygiene compliance system (AHHCS) with real-time audible alerts significantly increased hand hygiene compliance among healthcare workers to over 90% during its activation period.

When the alerts were turned off, compliance dropped to an average of 74%, demonstrating the effectiveness of the reminders in maintaining high hygiene standards in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated hand hygiene compliance system's audible alert reminder increases healthcare worker hand hygiene compliance. Webster, KL., Bishop, SM., Scott, LE., et al.[2023]

A systematic review of 28 studies found that strategies encouraging patients to remind healthcare professionals about hand hygiene can effectively increase patient involvement and intentions to do so.

The most effective strategy identified was encouraging healthcare professionals directly, although the overall quality of the studies was weak, indicating a need for better-designed research to determine the best methods for patient involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the effectiveness of strategies to encourage patients to remind healthcare professionals about their hand hygiene. Davis, R., Parand, A., Pinto, A., et al.[2018]

The implementation of an electronic infrared tap with voice reinforcement significantly improved hand hygiene compliance among healthcare workers in the NICU and PICU, with adherence rates increasing from 86.9% to 94.9% in the NICU and from 81.2% to 92.9% in the PICU after the intervention.

A total of 2718 hand hygiene events were monitored, demonstrating that the intervention effectively enhanced hand hygiene practices, which is crucial for preventing infections in vulnerable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Infrared Tap With Voice Reinforcement on Hand Hygiene Compliance of Healthcare Personnel. Kathirvel, M., Murugesan, A., Sastry, A., et al.[2023]

The study found that adding a verbal electronic audio reminder (EAR) to a hand hygiene education bundle significantly increased the use of hand sanitizer among patients, with those receiving the EAR using an average of 29.97 grams compared to 10.88 grams in the control group.

This suggests that simple audio reminders can effectively enhance patient self-management of hand hygiene, potentially leading to better health outcomes and reduced infections, while also indicating the need for further research on its application for promoting other healthy behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a verbal electronic audio reminder with a patient hand hygiene bundle to increase independent patient hand hygiene practices of older adults in an acute care setting. Knighton, SC., Dolansky, M., Donskey, C., et al.[2019]

The implementation of an electronic hand hygiene reminder system in an ICU led to a significant 24% increase in hand hygiene events, rising from 1538 to 1911 events per day, indicating improved compliance among healthcare workers.

The system not only increased the total number of hand hygiene actions but also improved the ratio of hand hygiene to room entry/exit events by 40%, demonstrating its effectiveness in promoting better hygiene practices in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Controlled Trial of an Electronic Hand Hygiene Reminder System. Ellison, RT., Barysauskas, CM., Rundensteiner, EA., et al.[2020]

The implementation of an automated hand hygiene monitoring system in a complex healthcare setting led to a significant and sustained increase in hand hygiene performance among staff, indicating its effectiveness in reducing hospital-acquired infections.

The study's multiphase design, which included baseline data collection and various intervention phases with feedback mechanisms, demonstrated that continuous monitoring and reminders can enhance compliance with hand hygiene practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated monitoring: a potential solution for achieving sustainable improvement in hand hygiene practices. Levchenko, AI., Boscart, VM., Fernie, GR.[2014]

Citations

1. reporter.nih.gov reporter.nih.gov/search/BQZBLXYTaEOy1BCteJXoiw/project-details/11125920

Project Details - NIH RePORTER Clean Hands Accessible and Manageable for Patients (CHAMPs), our investigator-developed and pilot tested bed rail-affixed hand-sanitizing dispenser, which ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05866393/clean-hands-accessible-and-manageable-for-patients-champs

Clean Hands Accessible and Manageable for Patients ... This study proposes the novel use of a bedrail-affixed technology-based patient hand hygiene system with verbal and visual reminders to ...

3. withpower.com withpower.com/trial/phase-pathogen-transmission-6-2023-29fcf

Hand Hygiene Reminders to Reduce Infections in Aging Patients This study proposes the novel use of a bedrail-affixed technology-based patient hand hygiene system with verbal and visual reminders to improve hospitalized ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03948672

CleanHands Sensor Based System to Improve Hand ... The purpose of this study is to determine if use of the CleanHands system can improve hand hygiene/personal protective equipment (PPE) compliance and reduce ...

5. goodday.health goodday.health/trials/5866393

R01AG078273 - GoodDay This study proposes the novel use of a bedrail-affixed technology-based patient hand hygiene system with verbal and visual reminders to improve hospitalized ...