LOCK Falls Program for Preventing Accidental Falls
(TEAM EFFORT Trial)
Trial Summary
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 data supports the effectiveness of the LOCK Falls Program treatment for preventing accidental falls?
Research shows that educational programs and targeted fall prevention strategies in hospitals have significantly reduced falls and injuries among older patients. For example, one program reduced inpatient falls by 46%, and another found that tailored education by trained professionals effectively decreased falls in older patients.12345
Is the LOCK Falls Program safe for humans?
The LOCK Falls Program, like other fall prevention strategies, focuses on improving safety and reducing falls, which are common and serious events in healthcare settings. While specific safety data for the LOCK Falls Program isn't detailed, similar programs have been implemented successfully in hospitals and nursing homes to enhance patient safety.678910
How is the LOCK Falls Program treatment different from other fall prevention treatments?
The LOCK Falls Program is unique because it focuses on a comprehensive approach to preventing accidental falls, potentially incorporating strategies like risk assessment models and education, which are not always emphasized in other treatments. This program may also involve specific guidelines and training for staff in high-risk areas, making it distinct from standard fall prevention methods.811121314
What is the purpose of this trial?
Background: State Veterans Home nursing homes (SVHs) care for 51% of all Veterans receiving VA-funded nursing home care. SVHs cost VA $1.2 billion yearly in per diem payments. This critical system provides care to a population of over 20,000 vulnerable Veterans annually but has been little researched and is in urgent need of attention. In some SVHs, the COVID-19 pandemic has resulted in large numbers of preventable illnesses, hospitalizations, and even deaths. Congress, the Government Accountability Office, and the Secretary have all called for greater VA involvement in this system that lacks a national quality improvement infrastructure and lags behind VA on many quality measures, including falls. This study addresses SVHs' need to reduce high fall rates-55% of residents experience at least one fall per quarter-by implementing an effective, evidence-based program known as LOCK. In LOCK, staff (1) "Learn from bright spots" (focus on evidence of positive change); (2) "Observe" (collect data through systematic observation); (3) "Collaborate in huddles" (conduct frontline staff huddles); and (4) "Keep it bite-size" (limit activities to 5-15 minutes). The program avoids reliance on existing quality improvement infrastructures, can be easily integrated into frontline staff routines, and has demonstrated success in improving clinical outcomes, including reductions in falls.Significance: This study provides the following. (1) Timely, evidence-based research support to improve care for SVHs' vulnerable population of aging Veterans. (2) Explicit integration of frontline staff expertise, ensuring interventions are practicable and successful. (3) Direct alignment with high-reliability principles-such as sensitivity to operations and deference to expertise-helping extend VA's high-reliability focus to SVHs.Innovation and Impact: This study contributes the following. (1) Advances the science of how to intervene in settings that do not have a strong, centralized quality improvement focus through rigorous investigation of how and why an intervention works in SVHs. (2) Investigates sustainment of the investigators' intervention-the extent to which it becomes part of usual care-for up to 12 months after completion of each step of the investigators' wedge-based design. (3) Provides timely, systematic investigation of a new area for VA research, gathering information on VA researcher-SVH partnerships to support future collaborations.Specific Aims: Aim 1: Investigate the effectiveness of the LOCK program at improving the investigators' primary outcome of any resident fall. This study will also investigate other resident clinical outcomes (mobility, medication changes, restraint and alarm use) and work-process outcomes for staff (job satisfaction, work engagement, burnout). This study will use both primary and secondary data collection. Aim 2: Evaluate the LOCK program's implementation. This study will use the replicating effective programs framework and multi-modal implementation facilitation strategies to implement the program. This study will use mixed methods to evaluate the program's reach, adoption, and implementation. Aim 3: Assess the extent of program sustainment. Mixed methods will enable examination of intervention sustainment at 3, 6, and 12 months post intervention and sustainment variability among sites.Methodology: This is a 4-year hybrid (Type 2) effectiveness-implementation study. It uses a pragmatic stepped-wedge randomized trial design and employs relational coordination theory and the RE-AIM framework to guide implementation and evaluation.Next Steps: This study (1) directly improves care for aging Veterans, (2) advances understanding of how to intervene in settings lacking quality improvement infrastructure, and (3) contributes knowledge about intervention sustainment. This study also addresses VA's Research Lifecycle stages of (a) scale up and spread and (b) sustainment. Findings may help improve care in other settings (e.g., inpatient mental health and domiciliary programs).
Research Team
Christine W. Hartmann, PhD
Principal Investigator
VA Bedford HealthCare System, Bedford, MA
A. Lynn Snow, PhD MS BS
Principal Investigator
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Eligibility Criteria
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
Exclusion Criteria
Timeline
Pre-intervention
Training on and implementing frontline staff huddles
Intervention
Implementation of the LOCK program focused on fall prevention
Follow-up
Participants are monitored for sustainment of the intervention
Treatment Details
Interventions
- LOCK Falls Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor