Pragmatic Trial to Increase Quality of Care in State Veterans Homes

Part of paid clinical trials in Bedford, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT05906095
Status
Enrolling By Invitation

Conditions

  • Accidental Falls
  • Long-Term Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • LOCK Falls Program — BEHAVIORAL
    The LOCK Falls Program helps multi-disciplinary frontline staff teams (nursing, physician, housekeeping, physical therapy, etc.) work together to identify and discuss risk factors for falling and use rapid-cycle QI techniques to pilot and monitor their actions to reduce resident falls.

Study Details

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).

Key Dates

Start date
Jan 8, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
10,160 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Intervention (each site serves as own control)
    wedge-based cluster randomized, controlled trial design with each SVH acting as its own control

Primary Outcome Measure

Rate of falls [ Time Frame: Change from pre-baseline to 12 months post intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Bedford HealthCare System, Bedford, MABedfordMassachusetts01730-1114-

Find similar trials in Bedford, MA

By research site
VA Bedford HealthCare System, Bedford, MA· Bedford, MA

Related Studies