LOCK Falls Program for Preventing Accidental Falls

(TEAM EFFORT Trial)

Overseen By Valerie Clark, MS RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Under 18, Non-veterans, Comatose, Hospice, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce accidental falls in nursing homes for Veterans by testing a program called LOCK, a fall prevention initiative. LOCK focuses on simple, effective strategies such as observing staff routines, holding short team meetings, and learning from successful examples. The trial seeks Veterans in State Veterans Homes who have fallen in the past six months or are considered at risk of falling. By improving safety and care, the trial aims to enhance life for aging Veterans and potentially benefit other healthcare settings. As an unphased trial, this study offers Veterans the chance to contribute to innovative fall prevention strategies that could improve their quality of life and assist others.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the LOCK Falls Program is safe for preventing accidental falls?

Research has shown that the LOCK Falls Program effectively prevents falls in older adults. One study found that the program successfully reduced falls among residents in similar settings. It easily integrates into daily routines and emphasizes practical steps like learning from positive examples, paying close attention, and collaborating in short, focused meetings.

No reports of negative effects have emerged from using the LOCK Falls Program. Since the program focuses on changing routines and improving communication, rather than medication or surgery, it is generally well-tolerated. Testing in similar environments has revealed no major safety concerns, making it a promising option for enhancing safety without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LOCK Falls Program because it takes a novel approach to preventing accidental falls, which is a common issue among older adults. Unlike traditional methods that focus on individual exercises or medication adjustments, the LOCK Falls Program employs a wedge-based cluster randomized, controlled trial design, allowing each site to serve as its own control. This unique method provides a more comprehensive understanding of fall prevention by addressing environmental and systemic factors in senior living facilities. By tailoring interventions to specific sites, the program aims to deliver more effective and personalized fall prevention strategies, potentially setting a new standard for how we tackle fall risks in vulnerable populations.

What evidence suggests that the LOCK Falls Program is effective for preventing accidental falls?

Research has shown that the LOCK Falls Program, which participants in this trial will receive, helps reduce falls among nursing home residents. One study demonstrated that the program significantly lowered the average number of falls per 1,000 patient days after implementation. The LOCK program relies on proven methods to enhance safety. It includes activities such as learning from successful examples, observing carefully, collaborating in team meetings, and keeping tasks short and focused. Overall, the program has successfully reduced falls and improved care for older adults. ^{2 6 7 8 9}

Who Is on the Research Team?

Camilla Benedicto Pimentel, PhD MPH

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

A. Lynn Snow, PhD MS BS

Principal Investigator

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Are You a Good Fit for This Trial?

This trial is for long-stay residents at State Veterans Home nursing homes who are veterans. It's specifically aimed at those who have fallen in the past six months or are considered at risk of falling by staff.

Inclusion Criteria

I am a Veteran living in SVH, have fallen in the last 6 months or am at risk of falling.

SVHs that are licensed and have electronic health records

Exclusion Criteria

For SVH residents: All non-Veteran residents

I am a veteran under 18 living in a State Veterans Home.

I am a veteran admitted for hospice care or I am comatose.

Timeline for a Trial Participant

Pre-intervention

Training on and implementing frontline staff huddles

4 weeks

Training sessions and planning meetings

Intervention

Implementation of the LOCK program focused on fall prevention

12 months

Regular huddles and monitoring activities

Follow-up

Participants are monitored for sustainment of the intervention

12 months

3, 6, and 12-month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• LOCK Falls Program

Trial Overview The LOCK Falls Program, designed to reduce falls among elderly veterans in nursing homes, is being tested. The program includes staff training on positive change, systematic observation, collaborative huddles, and bite-size activities that fit into daily routines.

How Is the Trial Designed?

Group I: Intervention (each site serves as own control) Experimental Treatment 1 Intervention

wedge-based cluster randomized, controlled trial design with each SVH acting as its own control

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The Local Healthcare Authority of Romagna developed a desktop application using open-source R software to monitor inpatient falls, which are the most common adverse events in hospitals, helping to improve patient safety.

The application not only tracked fall rates effectively across 29 hospital units but also identified critical data collection issues, leading to targeted improvement actions and significant cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Control Charts in Falls Prevention: The Experience of the Local Healthcare Authority of Romagna, Italy. Scagliarini, M., Boccaforno, N., Donati, R., et al.[2022]

Citations

1. bmjopen.bmj.com bmjopen.bmj.com/content/14/2/e084011

Improving safety and preventing falls using an evidence ... This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11547273/

Assessing the Effectiveness of a Non-Punitive Fall ... Following implementation of the program, results showed a statistically significant decrease in average fall rates per 1000 patient days from pre-intervention ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9432804/

Effects of Nurse-Led Fall Prevention Programs for Older Adults These results showed that including an individualized plan of care in the fall prevention intervention effectively reduced fall rates. Three studies resulted in ...

4. cdc.gov cdc.gov/falls/interventions/falls-compendium.html

Falls Compendium | Older Adult Fall Prevention This collection of effective fall interventions is designed to help public health practitioners, senior service providers, clinicians, and others

5. ahrq.gov ahrq.gov/sites/default/files/publications/files/fallpxtoolkit.pdf

Preventing Falls in Hospitals: A Toolkit for Improving ... The information in this toolkit is intended to assist service providers and hospitals in developing falls prevention protocols. This toolkit is.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10900326/

Improving safety and preventing falls using an evidence ... This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention.

7. ahrq.gov ahrq.gov/sites/default/files/publications/files/fallpxtoolkit_0.pdf

Preventing Falls in Hospitals: A Toolkit for Improving ... The information in this toolkit is intended to assist service providers and hospitals in developing falls prevention protocols. This toolkit is.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6339647/

Effects of a fall prevention program in elderly This study assessed the effects of a fall prevention program on the rate of fallers, the patient safety culture, and patient-perceived safety.

9. scholarlycommons.hcahealthcare.com scholarlycommons.hcahealthcare.com/cgi/viewcontent.cgi?article=1982&context=hcahealthcarejournal

Inpatient Falls: Epidemiology, Risk Assessment, and ... Risk assessment tools, such as the Hendrich II Fall Risk Model, Morse Fall Scale, and STRATIFY, were developed to help identify those at risk.