Pragmatic Trial to Increase Quality of Care in State Veterans Homes

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 m

• Rate of residents steady at all times [Срок оценки: Change from pre-baseline to 12 months post intervention]
• Rate of polypharmacy [Срок оценки: Change from pre-baseline to 12 months post intervention]
• Rate of Restraint use [Срок оценки: Change from pre-baseline to 12 months post intervention]
• Rate of Hospitalization [Срок оценки: Change from pre-baseline to 12 months post intervention]