Reducing Fall Prevention Alarms in Hospitals

Recruiting at 19 trial locations

Overseen By Ronald I Shorr, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce the use of fall prevention alarms in hospitals by testing two coaching methods: high-intensity and low-intensity. The aim is to determine which approach more effectively implements changes in fall prevention practices. Individuals involved in fall prevention efforts at certain hospitals may be suitable candidates for this trial. As an unphased trial, it allows participants to contribute to innovative strategies that could enhance patient safety in hospitals.

Do I need to stop taking my current medications for this trial?

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

What prior data suggests that these coaching strategies are safe for hospital use?

Research has shown that reducing the use of fall prevention alarms in hospitals is generally safe. These changes focus on improving procedures rather than adding new drugs or devices, making them easy for hospitals to adopt.

In this study, high-intensity coaching involves training hospital staff over several months to better implement these changes. Previous studies on similar coaching methods have not identified any major safety concerns. The goal is to enhance current practices without introducing potentially risky treatments, keeping the chance of negative effects very low.

In summary, these coaching methods are safe and aim to improve patient care without adding new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Reducing Fall Prevention Alarms in Hospitals trial because it explores innovative coaching methods to improve patient safety. Unlike traditional fall prevention strategies that often rely on alarms and monitoring, this trial focuses on behavioral and organizational changes through coaching. High Intensity Coaching offers an intensive approach with comprehensive training and ongoing support, including weekly sessions and real-time assistance, which could lead to more sustainable changes in hospital settings. Low Intensity Coaching, on the other hand, provides a more streamlined approach, focusing on initial guidance and empowering local leaders to drive change. By shifting the focus from alarms to proactive coaching, this trial could potentially reduce falls more effectively and improve patient outcomes.

What evidence suggests that this trial's coaching strategies could be effective in reducing fall prevention alarms in hospitals?

Research shows that hospitals can effectively reduce the use of fall prevention alarms through strategic coaching. In this trial, participants will join either high-intensity or low-intensity coaching groups. Studies have found that personalized coaching, such as the high-intensity approach, helps hospitals rely less on these alarms. This method includes thorough training on changing behaviors and organizational practices, which has been linked to successfully stopping current practices. Evidence suggests that this coaching can lead to better adoption of new safety practices and may lower patient fall rates. High-intensity coaching provides ongoing support and tailored advice, helping to overcome obstacles and improve the process. Overall, research supports this strategy as a promising way to enhance patient safety without heavily depending on alarms. ^{1 2 4 6 7}

Who Is on the Research Team?

Ronald I Shorr, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for stakeholders involved in fall prevention at up to 30 hospitals participating in the NDNQI program. It's designed for those who are directly engaged with patient safety and want to explore alternative methods to prevent falls without relying on alarms.

Inclusion Criteria

You are a stakeholder in fall prevention at up to 30 NDNQI hospitals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline data collection on fall prevention alarm prevalence and patient falls

4 weeks

Monthly data collection

Intervention

Implementation of tailored de-implementation strategies with high or low intensity coaching

30 months

Weekly virtual sessions initially, then monthly follow-ups

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Coaching
• Low Intensity Coaching

Trial Overview The study tests two levels of coaching intensity (low and high) aimed at reducing reliance on fall prevention alarms. Hospitals will be randomly assigned to receive either low-intensity or high-intensity coaching, which includes education, audit/feedback, and guidance from opinion leaders.

How Is the Trial Designed?

Group I: High Intensity Coaching Active Control 1 Intervention

In Quarter 1, high intensity initiation coaching will consist of a four-hour orientation session that will include: * comprehensive information on behavior and organizational change theory, * suggested approaches, and * in-depth training on behavioral and organization-focused change techniques to stimulate implementation efforts. Commencing in Quarter 2, high intensity sustainability coaching will consist of: * weekly virtual follow up sessions for the first month, followed by private monthly coaching follow up sessions via a virtual format. * Access to additional monthly web-based, synchronous "office hours" for group discussion on progress and customized troubleshooting to assist in navigating barriers. * Sites will also have access to "on call" assistance with coaches to assist with navigating challenges in real time.

Group II: Low Intensity Coaching Placebo Group 1 Intervention

In Quarter 1, low intensity initiation coaching will be conducted. It will consist of: * initial two-hour orientation session with introductory content on behavior change and organizational change theory and techniques, * an overview of implementation phases, and * selection of tailored de-implementation strategies for that site based on readiness for change, focus group data and local resources. Implementation coaches will provide the Fuld Toolkit for the site with suggestions for assigning strategies, local leaders, and development of timelines for de-implementation. Coaches will instruct site Team Leaders to establish the primary mechanism for sharing baseline and trended data in real time.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A systematic review of 59 studies on fall prevention in U.S. acute care hospitals found that while many interventions included multiple components, only 45% of studies with concurrent controls provided sufficient data to compare fall rates, indicating a need for better reporting.

The pooled analysis showed a postintervention incidence rate ratio (IRR) of 0.77, suggesting a potential reduction in falls, but the lack of systematic associations between implementation strategies and effectiveness highlights the need for improved adherence and detailed reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital fall prevention: a systematic review of implementation, components, adherence, and effectiveness. Hempel, S., Newberry, S., Wang, Z., et al.[2022]

A quality improvement project at Jigme Dorji Wangchuck National Referral Hospital aimed to reduce pediatric inpatient falls by 25% over 6 months, focusing on fall risk assessment and staff education.

The project successfully achieved a 49.3% reduction in fall rates by implementing a multi-strategic approach, including continuous risk assessment and targeted interventions for high-risk patients, resulting in nearly 90 fall-free days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team approach to fall reduction in paediatric ward of national referral hospital, Thimphu, Bhutan: a quality improvement initiative. Chhetri, K., Rinchen, U., Lamichaney, G., et al.[2022]

In a study of 1,489 patients across 59 nursing units in 57 US hospitals, over one-third of patients had bed and chair alarms activated, indicating widespread use despite their questionable effectiveness and potential negative impacts.

Alarm use varied significantly between units, with only 29% of the differences in alarm usage explained by patient fall risk factors, suggesting that unit practices play a larger role in alarm implementation than individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unit-level variation in bed alarm use in US hospitals. Staggs, VS., Turner, K., Potter, C., et al.[2021]

Bed exit alarms are commonly used in healthcare settings as part of fall-prevention programs, but there is no strong evidence from large-scale randomized controlled trials to support their effectiveness.

Nurses reported that while bed alarms may help prevent falls, they still required hourly monitoring of patients, indicating that alarms alone are not sufficient for ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' experiences with bed exit alarms may lead to ambivalence about their effectiveness. Hubbartt, B., Davis, SG., Kautz, DD.[2019]

A study involving 88 patients and 60 nurses at two academic medical centers successfully refined 16 fall risk and prevention icons through iterative testing, improving their clarity and effectiveness for patient engagement.

The refined icons are intended to enhance communication among patients, nurses, and families, which could lead to better adherence to fall prevention plans and ultimately reduce the incidence of falls in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validating Fall Prevention Icons to Support Patient-Centered Education. Leung, WY., Adelman, J., Bates, DW., et al.[2023]

A pilot study in a 52-bed surgical unit tested a bed-height alert system designed to remind staff to keep patient beds at the lowest position, which is crucial for fall prevention.

Feedback from nursing staff (18 RNs and 13 PCAs) indicated that the alert system was feasible and could enhance patient safety by potentially reducing bed-related falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How feasible was a bed-height alert system? Tzeng, HM., Prakash, A., Brehob, M., et al.[2021]

The study proposes a trial called Alarm with Care to test strategies for reducing the use of fall prevention alarms in 30 adult medical units across US hospitals, addressing the negative impacts of these alarms on both patients and healthcare staff.

The trial will compare high- versus low-intensity coaching to support the de-implementation of alarms, with the primary outcome being the rate of alarm use, while also monitoring fall rates and related injuries to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alarm with care-a de-implementation strategy to reduce fall prevention alarm use in US hospitals: a study protocol for a hybrid 2 effectiveness-implementation trial. Turner, K., McNett, M., Potter, C., et al.[2023]

A multicentre study involving 17 geriatric wards in Belgium found that a fall prevention guideline was deemed useful by over 69% of healthcare workers, with 512 patients assessed during the one-month trial.

Despite the guideline's perceived usefulness, barriers such as time investment and communication issues hindered its long-term integration into daily practice, highlighting the need for better coordination and support from hospital management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing a practice guideline for fall prevention on geriatric wards: a multicentre study. Milisen, K., Coussement, J., Arnout, H., et al.[2013]

A falls prevention training program involving 38 hospitals led to significant reductions in fall rates, with a mean decrease of 1.7 falls per 1000 patient days after 3 months of implementation.

Statistical analysis showed a strong significance (P < .01) in the reduction of falls, indicating the effectiveness of the unit-based initiatives focused on risk assessment and post-fall evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Practice Nurse-Led Statewide Collaborative to Reduce Falls in Hospitals. Gray-Miceli, D., Mazzia, L., Crane, G.[2017]

A study involving 3606 patients across eight rehabilitation units showed that individualized falls-prevention education significantly reduced the rate of falls and injurious falls among older patients, with a 40% reduction in falls per 1000 patient-days compared to the control group.

The intervention also led to a decrease in the proportion of patients who experienced falls, with an adjusted odds ratio of 0.55, indicating that the education program effectively improved patient safety without increasing the length of hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Hill, AM., McPhail, SM., Waldron, N., et al.[2022]

Multifactorial fall prevention programs that include risk assessments, alerts, environmental modifications, and staff education have been shown to significantly reduce falls and fall-related injuries in hospitalized patients, based on an analysis of 13 studies.

Implementing evidence-based interventions is crucial for hospitals to effectively lower the incidence of falls and enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fall prevention in hospitals: an integrative review. Spoelstra, SL., Given, BA., Given, CW.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10696656/

Alarm with care—a de-implementation strategy to reduce ... We propose testing the effectiveness and implementation of Alarm with Care, a de-implementation strategy to reduce fall prevention alarm use.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06089239?term=AREA%5BConditionSearch%5D(%22Iatrogenic%20Disease%22)&rank=10

Choosing Wisely: De-implementing Fall Prevention Alarms ... This is a Hybrid II de-implementation study to reduce use of fall prevention alarms in hospitals. The intervention consists of tailored, site-specific ...

3. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/13/4/e003006

Implementation strategies of fall prevention interventions in ... Our review explored implementation strategies for FPIs, how these strategies are operationalised and their impact on fall rates and adherence.

4. researchgate.net researchgate.net/publication/376236158_Alarm_with_care-a_de-implementation_strategy_to_reduce_fall_prevention_alarm_use_in_US_hospitals_a_study_protocol_for_a_hybrid_2_effectiveness-implementation_trial

(PDF) Alarm with care—a de-implementation strategy to ... We will evaluate effectiveness and implementation outcomes and examine the effect of multi-level (e.g., hospital, unit, and patient) factors on effectiveness ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05587-w

Features of effective hospital fall prevention trials We conducted an ICA of systematically identified randomised controlled trials of interventions for preventing falls in older people in hospitals.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683959/

Implementation strategies of fall prevention interventions in ... Our review explored implementation strategies for FPIs, how these strategies are operationalised and their impact on fall rates and adherence.

7. qualitysafety.bmj.com qualitysafety.bmj.com/cgi/content/short/bmjqs-2024-018391v1?rss=1

a group concept mapping study The objectives of this study were (1) to identify, conceptualise and select strategies to deimplement fall prevention alarms and (2) to obtain feedback from key ...