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Completed Not applicable Interventional Accepts healthy volunteers

Pragmatic Trial to Increase Quality of Care in State Veterans Homes

ClinicalTrials.gov ID: NCT05906095

Public ClinicalTrials.gov record NCT05906095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pragmatic Trial to Increase Quality of Care in State Veterans Homes: Improving Safety Using an Evidence-based, Frontline Staff Huddling Practice

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05906095
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
574 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2024
Primary completion
Aug 25, 2026
Completion
Aug 25, 2026
Last update posted
Sep 3, 2026

2024 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
VA Bedford HealthCare System, Bedford, MA Bedford Massachusetts 01730-1114

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05906095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05906095 live on ClinicalTrials.gov.

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