Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05906095 |
| Other study ID # |
IIR 21-014 |
| Secondary ID |
I01HX003420 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2024 |
| Est. completion date |
July 31, 2026 |
Study information
| Verified date |
January 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
Background VA is highly invested in a struggling system in urgent need of help: State
Veterans Homes. State Veterans Home nursing homes (SVHs) care for 51% of all Veterans
receiving nursing home care paid for by VA. These 151 homes are owned and operated by states
but constructed with 65% VA funding and certified and substantially financially supported by
VA. Occupancy must be at least 75% Veterans; current average occupancy is 93% Veterans. VA
paid $1.2 billion in FY19 to SVHs in per diem payments, which is expected to rise by FY24 to
$1.7 billion. In addition, since the prior submission, the VA announced $1 billion in
additional funding for SVH to aid with responses to the pandemic. And the Facility-Based Care
Modernization Plan consolidates VA-led SVH oversight within the Office of Geriatrics and
Extended Care, with an additional $13 million annually. SVHs are undoubtedly a critical
component of VA's commitment to care for older Veterans.
The SVH resident population is older than that in VA's Community Living Centers or
VA-contracted community nursing homes: almost 50% of SVH residents are over age 84 (compared
with 21% and 24%, respectively). In addition, 78% of SVH residents stay over 100 days
(compared with 21% and 30%, respectively). The SVH system is also not centralized. SVHs lack
connection to hospital QI infrastructures and, up to now, a national quality improvement (QI)
infrastructure. Yet all follow VA SVH-specific regulations and will soon become Centers for
Medicare and Medicaid-certified. A national SVH QI is also slowly coming.
Falls are a critical safety issue, and huddles show promise as an intervention. The focus for
this study-falls of any type-represents an important quality and safety measure that is also
meaningful during the COVID pandemic. Falls are consistently the most reported SVH-related
issue brief to VA Central Office. In FY20, 75% (255 of 339) of briefs related to falls. For
older adults, falls are a leading cause of injury and death. A large database study of
nursing home residents' premature deaths from external causes found 82% due to falls. Falls
are unintended, not due to acute events (seizure, stroke) or external forces (push). In
addition to injuries, falls result in reduced mobility, functional decline, and psychological
stress. In nursing homes, they also result in substantial staff time and cost increases. Yet
falls are also largely preventable and thus represent a prime target for interventions.
Falls are typically caused by multiple, interacting factors, such as age, cognitive
impairment, chronic conditions, balance impairment, lower extremity weakness, medications,
and environmental hazards. Many of these are modifiable. A 2020 review of fall prevention
interventions in nursing homes found evidence for the efficacy of some targeted
staff-education and multi-factorial clinical interventions. One staff-focused intervention
with a history of success in preventing falls is huddling. Huddles are brief, stand-up
meetings to facilitate efficient information exchange. Nursing home and hospital studies have
achieved significant reductions in fall rates using post-fall huddles and general
fall-prevention huddles. One nursing home study, for example, attributed a 37% reduction in
fall rates to the introduction of regular fall-focused huddles. Studies indicate these
huddles improve communication and reflection, increase nursing and patient involvement, and
reduce task and coordination errors.
SVHs have high rates of any fall. This study's primary outcome of "fall during episode of
care" had a FY20 Q3 rate, averaged across 4 quarters, of 55.4% of residents. The 10th to 90th
percentile range was narrow: 44.4% to 65.9%. On average, over half the residents in an SVH
experience at least one fall per quarter.
The LOCK program is an evidence-based solution to address critical clinical issues. The LOCK
program avoids reliance on a national or even strong local pre-existing QI infrastructure.
Instead, the LOCK program itself teaches the fundamental QI structures and processes and
helps each nursing home create its own. LOCK stands for (1) Learn from bright spots, (2)
Observe, (3) Collaborate in huddles, and (4) Keep it bite-size, with huddle collaboration as
the foundational element. The LOCK program is based on 4 evidence-based practices. (1)
Strengths-based learning: identifying and learning from exceptional performance (positive
deviance) by pinpointing already-existing solutions (bright spots) for overcoming hurdles and
achieving success. (2) Observation: using observation to study human factors within a work
system and gather data. (3) Relationship-based teams: improving healthcare outcomes by
changing organizational practices and relational dynamics using frontline staff huddling. (4)
Efficiency: keeping communication focused, direct, and brief and keeping elements of a change
effort manageable. The program helps multi-disciplinary frontline staff teams (nursing,
physician, housekeeping, physical therapy, etc.) work together to identify and discuss risk
factors and use rapid-cycle QI techniques to pilot and monitor their actions. Actions that
staff might take are individualized to the resident and may include medication review,
occupational therapy, exercise, socialization, and a host of other options.
Relational Coordination represents the critical ingredient for achieving lasting improvement
Relational coordination is an evidence-based framework emphasizing that staff across all job
types must be connected by high quality interactions and supportive relationships to create
an environment in which teams achieve improved results. Healthcare organizations-including
nursing homes-with high relational coordination achieve better clinical outcomes: higher
quality of care, shorter length of stay, lower pain, and higher functioning. For staff
working in hospital and nursing home settings, high relational coordination is associated
with greater job satisfaction, greater job engagement, and less burnout.
Objectives This 4-year hybrid (Type 2) effectiveness-implementation study uses a pragmatic
stepped-wedge randomized trial design in 8 SVHs and relies on relational coordination theory
and the RE-AIM framework.
Aim 1: This study will use primary and secondary data collection to investigate the
effectiveness of the LOCK program at improving resident falls and other resident clinical
outcomes (mobility, medication changes, restraint, and alarm use) and work-process outcomes
for staff (job satisfaction, work engagement, burnout).
Aim 2: To support successful program implementation, this study will use the replicating
effective programs framework and multi-modal implementation facilitation strategies. The
program's reach, adoption, and implementation will be evaluated using mixed methods.
Aim 3: This study will employ mixed methods to assess the extent of program sustainment
(maintenance) at 3-, 6-, and 12-months post intervention and sustainment variability across
sites.
Study Design
Replicating effective programs framework This study will use the replicating effective
programs framework to examine the site-specific learning context and implementation barriers,
focusing on the pre-implementation and implementation phases. Pre-implementation focuses on
implementation preparation and obtaining broad buy-in. It encompasses tailoring, orienting,
planning, training, and technical assistance. Implementation comprises ongoing support,
training, evaluation, and feedback.
Recruitment Methods
SVH recruitment and eligibility The study team will work with the National Association of
State Veterans Homes (NASVH) to recruit SVHs. NASVH leadership will send an email to SVHs
describing the study. The study team will send a follow-up email to SVH administrators,
asking them to participate. The study team will continue to send emails until a pool of at
least 14 SVHs is reached, from which the research team will choose a sample of 8 SVHs.
Staff recruitment SVH employees will be recruited for survey participation and qualitative
interview involvement through emails from study team members, in-person during site visits,
and at staff meetings using scripts written by research personnel.
Survey recruitment The research team will invite all SVH staff from the 8 participating SVHs
to complete online surveys. This survey will be administered at four time points:
pre-intervention, baseline, post-intervention, 6- and 12-month follow up.
Qualitative interview recruitment LOCK program implementation interviews: The research team
will recruit the LOCK program leadership team members as well as a sample of frontline staff
who participated in the huddles to participate in semi-structured qualitative interviews at
two time points: baseline and post-intervention.
LOCK Program Sustainment interviews: In addition, at the 3-month and 6-month follow up time
points, the study team will conduct semi-structured qualitative phone interviews with key SVH
staff involved in the intervention. These include the LOCK program leadership team members
and staff who participated in frontline staff huddles.
Resident recruitment At two time points (baseline and post-intervention) the research team
will conduct semi-structured interviews with cognitively intact Veteran residents living in
the participating SVHs who have a history of falling.
Intervention implementation
Pre-intervention phase - Training on and implementing frontline staff huddles: The leadership
team will serve as the study's internal facilitators, responsible for spearheading and
supporting staff in implementing the LOCK program during both the pre-intervention and
intervention periods. In the pre-intervention phase, the investigators will use the
investigators' team's extensive VA experience to teach the leadership team how to develop and
run interdisciplinary, relationally coordinated frontline staff huddles.
Intervention - LOCK program focused on fall prevention: The intervention begins at the
baseline visit. The research team will hold a 4-hour training for each SVH's leadership team
on risk factors for falling and how to guide staff to use their frontline staff huddles to
continually identify residents at highest risk of falling, explore residents' personal
histories, and develop individualized action plans based on risk factors. Staff will
continually target a fluid "watch" list of residents at highest risk of falling. Consistent
with the replicating effective programs framework, The research team will guide the teams to
teach staff to use continual QI methods to monitor the impact of their action plans. They
will use observation and data collection, including environmental assessments, and post-fall
huddling to identify fall prevention intervention opportunities.
AIM 1: Primary data collection, staff and resident Staff surveys: SVH staff will be recruited
for research surveys via email. Surveys will be administered electronically using a
VA-approved online survey portal electronic data capture.
Residents discussed in huddles: As part of the huddling process, staff will keep a running
huddle log that contains information on which residents are discussed and why. Data from the
huddle logs will be used as process measures to determine how huddles are used to focus on
residents potentially at risk for falling.
Resident interviews: The study team will aim to recruit 3-5 residents per site. Consented
residents will be interviewed; audio recordings will be collected via IRB-approved methods
and transcribed verbatim.
AIM 2: Data collection instruments RE-AIM evaluation overview For Aim 2, LOCK program's
implementation will be evaluated using RE-AIM's first 4 (reach, effectiveness, adoption, and
implementation) constructs.
FRAME To assess any modifications to the intervention, research staff will use a Framework
for Reporting Adaptations and Modifications-Enhanced (FRAME) checklist when they learn from
sites that modifications were made.
Implementation Facilitation Time Tracking Log: This tool, developed through a VA QUERI grant,
documents the time, activities, and personnel involved in implementation facilitation
efforts. External facilitators will record, on an at least weekly basis, facilitation event
type, mode of communication, with whom they interacted, and specific activities, thereby also
gathering information on tailoring and uptake of the intervention.
Relational Coordination Survey: The survey asks participants to rate their experiences with
their own and other workgroups on the 7 key dimensions of relational coordination (frequency,
timeliness, accuracy, and problem-solving nature of communication; shared goals; shared
knowledge; and mutual coworker respect).
Qualitative interviews: LOCK Program implementation interviews with leadership team and
staff: The research team developed a semi-structured interview guide, with undergirding from
relational coordination and the RE-AIM framework. The guide will assess participants'
impressions of the content, structure, and implementation of the LOCK program; how it
affected staff interactions; who did/did not participate and why; how it affected resident
outcomes, including unexpected results; barriers to or facilitators of implementing it; and
how the SVH sustained it.
Field notes: The research team will collect field notes during site visits using a structured
template. It captures general impressions from informal conversations and overall impressions
of the physical layout and atmosphere, staff-staff interactions, staff-resident interactions,
processes, etc.
AIM 2: Primary data collection, staff LOCK Program Implementation interviews: The research
team will recruit the LOCK program leadership team members as well as a sample of frontline
staff who participated in the huddles. The research team will use a semi-structured
qualitative interview guide informed by relational coordination theory and RE-AIM to examine
variation in implementation and sustainment and for analysis of barriers.
AIM 3: Additional sustainment-specific instruments Clinical Sustainability Assessment Tool:
To assess sustainment (maintenance), site program leadership and research team members will
use the Clinical Sustainability Assessment Tool independently to rate sites at
pre-intervention, baseline, post-intervention, and 3-, 6-, and 12-months post intervention.
AIM 3: Data collection Site program self-assessment: Each site will complete a
Self-Assessment Tool to assess team performance at pre-intervention, baseline,
post-intervention, and 3, 6, and 12 months post intervention.
LOCK Program sustainment interviews: The research team will conduct semi-structured
qualitative phone interviews with key SVH staff involved in the intervention: site leadership
team members and staff who participated in frontline staff huddles ..
Data Analysis
AIM 1: Quantitative data analysis 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. The investigators will predict the likelihood of falling and test for
differences in the likelihood of falling given the presence or absence of prior falls. The
research team will evaluate change in the likelihood of falling, expressed as an aggregate
likelihood for SVHs in terms of rates. Within- and between-cluster data will be used to
determine effectiveness of the LOCK program over time.
The level of analysis will be the individual SVH resident nested within SVH. The research
team will examine differences in the investigators' primary outcome across the
pre-intervention through sustainment periods using a multi-level mixed-models approach and
either generalized linear mixed models or generalized estimating equations. The aggregate
model-adjusted likelihood of falls will be reported at the SVH level as the rate of any fall
per 100 residents.
The primary analysis will be a partial intention-to-treat analysis using the rate of
participants experiencing any fall during an MDS assessment period as the outcome. All
residents with pre-intervention assessments will be included. For residents who leave the SVH
during the study for whatever reason, multiple imputation will be used to estimate missing
data from individuals' existing data, assuming no change from their last available
assessment, and incorporating an estimate of random variation based on observed data. The
research team will also conduct a complete case analysis (individuals with data from all
measurement periods) to test the sensitivity of the primary analysis results.
Participating SVHs will be treated as random effects with residents clustered within SVHs.
The analysis will include estimates using both unadjusted and adjusted models.
Individual-level and SVH-level characteristics will be used in the adjusted models and a Type
I error rate of 5% ( < .05) to identify statistically significant associations.
A similar approach will be used to test the intervention's impact on secondary outcomes. The
analysis will include an exploratory heterogeneity of treatment effects analysis (difference
in difference analysis) examining the relative effect of the intervention on residents with
and without delirium and urinary tract infection.
AIM 1: Qualitative data analysis Resident interviews: The qualitative analysis will include a
content analytic approach facilitated by a qualitative research software (e.g., NVivo). In
the case of the resident interviews, a primary analyst will first read through 3 documents,
highlighting key words and phrases that pertain to the relevant relational coordination
constructs as they relate to the following: (a) experiences related to falling or nearly
falling, (b) interactions with staff around falls and fall prevention, (c) falls and the
environment, (d) resident-perceived risk factors and fall prevention facilitators, (e) other.
AIM 2: Relational Coordination Survey data analysis To assess effectiveness, the
investigators will use data from the Relational Coordination Survey collected at 3 time
points: pre-intervention, immediately after the intervention ends (post-intervention), and 6
months after intervention ends. The study will use Relational Coordination Survey standard
analysis techniques to calculate SVH total scores as well as scores for within and between
each SVH workgroup.
AIM 2: Qualitative data analysis The qualitative data will be analyzed using a content
analytic approach facilitated by a qualitative research software (e.g., NVivo). One
qualitative team member will be the primary data analyst for each data source. A primary
analyst will first read through 3 documents, highlighting key words and phrases that pertain
to the relevant relational coordination and RE-AIM constructs as they relate to the
following: (a) content, structure, or implementation of the LOCK program, (b) barriers to or
facilitators of implementing the program, (c) system-level strategies for sustainment, (d)
suggestions for improvements, (e) mechanisms and mediators of change, and (f) other. The
primary analyst will then create a preliminary codebook of these data. A second researcher
will use identical methods and create a similar codebook. When all data have been analyzed
for a source, the primary analyst will create a content-analytic summary table.
AIM 2: Consolidation The research team will assess implementation employing RE-AIM dimensions
to summarize Aim 2 findings across data sources into a summary matrix by and across sites.
AIM 3: Data Analysis The use of both quantitative data collection and interviews represents a
key opportunity to triangulate data. Raters will combine the site level qualitative summary
tables combined with quantitative results to examine patterns of variation of implementation
and impacts on effectiveness. The research team will develop a protocol for rating and
conduct full-team consensus-reaching discussions. This will enable integration of the
investigators' mixed-methods data on LOCK program progress over time at the site-level. The
investigators will also assess the coherence between the quantitative and qualitative results
and look for areas of confirmation, expansion, and discordance. The primary goals will be to:
1) integrate quantitative and qualitative findings to identify facilitators of and barriers
to sustainment and 2) identify facilitating and hindering practices using relational
coordination as a guide.
