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.

introductionFalls in nursing homes are a major cause for decreases in residents' quality of life and overall health. This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention. The LOCK Falls Programme involves the entire front-line care team in (1) focusing on evidence of positive change, (2) collecting data through systematic observation and (3) facilitating communication and coordination of care through the practice of front-line staff huddles. METHODS AND ANALYSIS: The study protocol describes a mixed-methods, 4-year hybrid (type 2) effectiveness-implementation study in State Veterans Homes in the USA. The study uses a pragmatic stepped-wedge randomised trial design and employs relational coordination theory and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to guide implementation and evaluation. A total of eight State Veterans Homes will participate and data will be collected over an 18-month period. Administrative data inclusive of all clinical assessments and Minimum Data Set assessments for Veterans with a State Veterans Home admission or stay during the study period will be collected (8480 residents total). The primary outcome is a resident having any fall. The primary analysis will be a partial intention-to-treat analysis using the rate of participants experiencing any fall. A staff survey (n=1200) and qualitative interviews with residents (n=80) and staff (n=400) will also be conducted. This research seeks to systematically address known barriers to nursing home quality improvement efforts associated with reducing falls. ETHICS AND DISSEMINATION: This study is approved by the Central Institutional Review Board (#167059-11). All participants will be recruited voluntarily and will sign informed consent as required. Collection, assessment and managing of solicited and spontaneously reported adverse events, including required protocol alterations, will be communicated and approved directly with the Central Institutional Review Board, the data safety monitoring board and the Office of Research and Development. Study results will be disseminated through peer-reviewed publications and conference presentations at the Academy Health Annual Research Meeting, the Gerontological Society of America Annual Scientific Meeting and the American Geriatrics Society Annual Meeting. Key stakeholders will also help disseminate lessons learnt. TRIAL REGISTRATION NUMBER: NCT05906095.