Pragmatic Trial to Increase Quality of Care in State Veterans Homes

NCT05906095 | Enrolling By Invitation

• 2 other identifiers: IIR 21-014I01HX003420
• Study Type: interventional
• Target: 10,160
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Long-Term Care; Accidental Falls

Keywords

Veterans; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Rate of falls

  The investigators' primary outcome will be measured using the MDS indicator of "any falls since admission/entry or reentry or prior assessment" for long-stay residents. Any fall is less sensitive to under-reporting since it is not affected by the absolute number of falls.

  Change from pre-baseline to 12 months post intervention

Secondary Outcomes (4)

• Rate of residents steady at all times

  Change from pre-baseline to 12 months post intervention

• Rate of polypharmacy

  Change from pre-baseline to 12 months post intervention

• Rate of Restraint use

  Change from pre-baseline to 12 months post intervention

• Rate of Hospitalization

  Change from pre-baseline to 12 months post intervention

Other Outcomes (3)

• Rate of Job satisfaction

  Change from pre-baseline to 12 months post intervention

• Rate of Work engagement

  Change from pre-baseline to 12 months post intervention

• Rate of Staff Burnout

  Change from pre-baseline to 12 months post intervention

Study Arms (1)

Intervention (each site serves as own control)

OTHER

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

Behavioral: LOCK Falls Program

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.

Intervention (each site serves as own control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SVHs that are
• licensed and
• have electronic health records.
• For SVH residents: All
• long-stay SVH residents who are
• Veterans
• who have experienced a fall in the past six months or whom SVH staff identify as at risk of falling.

You may not qualify if:

• For SVH residents:
• Veterans under the age of 18,
• all non-Veteran residents, and
• Veterans who are comatose
• or admitted for hospice and respite care.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (1)

• Nash P, Clark V, McConnell E, Mills W, Morgan R, Pimentel C, Ritchey K, Levy C, Snow AL, Hartmann C. Improving safety and preventing falls using an evidence-based, front-line staff huddling practice: protocol for a pragmatic trial to increase quality of care in State Veterans Homes. BMJ Open. 2024 Feb 26;14(2):e084011. doi: 10.1136/bmjopen-2024-084011.

  PMID: 38413157 DERIVED

Study Officials

• Camilla Benedicto Pimentel, PhD MPH

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

• A. Lynn Snow, PhD MS BS

  Tuscaloosa VA Medical Center, Tuscaloosa, AL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a mixed-methods, hybrid (Type 2) effectiveness-implementation study with primary and administrative data collection. Our design is an incomplete stepped-wedge cohort design, where each SVH (n = 8) serves as its own control and residents and staff within SVHs are followed longitudinally from pre-intervention through sustainment measurement periods. This design is effective for evaluating interventions implemented at the site level, with strategies that target groups rather than individuals. The investigators designed an initial 3-month pre-intervention period in which each SVH builds its frontline staff huddle practice across all units. After this, each SVH will begin the 3-month LOCK intervention on all its units. A 12-month sustainment period follows. To ensure feasibility with a relatively small team, the investigators have 2 waves in the stepped-wedge design so no more than 2 site visits occur in the same month and travel remains manageable.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 15, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting 6 months from publication and ending 3 years following article publication.
• Access Criteria: Investigators who propose a methodologically sound plan for use of the data will be provided access. Researchers should send specific requests for final data sets (maintained locally) by contacting the core research group until enterprise-level resources become available for long-term storage and access.

Locations

US (1)