Description

1. Background/Literature Review 1.1 Background Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) . This is a research study to evaluate the comparative effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard of care treatment in preventing falls in community-dwelling older adults. Current standard of care is for the primary care physicians to evaluate patients at risk of falls, order medical work up, specialist physician consultation(s), medication changes and other interventions as needed, and prescribe physical and/or occupational therapy. Widely publicized guidelines for primary care physicians managing older adults at risk of falls include the American Geriatrics Society (3) and/or the Center for Disease Control and Prevention Stopping Elderly Accidents Deaths and Injuries (STEADI) guidelines. The American Geriatrics Society recommends that older adults undergo annual fall risk screening by physicians , which is an essential component of the annual Medicare wellness visit . To support a structured approach for physician-led fall prevention, the Centers for Disease Control and Prevention's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative provides an algorithmic framework for identifying, risk stratifying, and managing older adults at risk for falls, specifically designed for primary care providers . The STEADI algorithm includes evaluations of fall frequency, fear of falling, assessments for postural hypotension, foot deformities, visual and cognitive deficits, a basic screen for balance and gait issues, and a review of medications that could increase fall risk . Importantly, the STEADI approach positions physicians as key leaders in fall prevention management, utilizing physical therapy, community evidence-based fall prevention programs, podiatry and other referrals as part of a comprehensive, multifactorial intervention protocol . Limited non-randomized data suggest that implementing the STEADI strategy in primary care settings can reduce fall-related hospitalizations . The intervention arm of the Steady Strides Protocol includes both standard care and a structured fall prevention program. The Steady Strides Protocol is not an experimental treatment, it has been practiced at our clinic for several years already and has been paid for by the insurance providers as regular physiatry and rehabilitation care since 2017.Steady Strides Fall Prevention Protocol has been already shown in retrospective studies to have significant efficacy in preventing falls in community dwelling older adults . Novelty of the protocol lies not in introducing new rehabilitation techniques but in translating evidence-based interventions into a structured, consistent and easily adoptable framework for clinical practice. Since systematic reviews consistently highlight the efficacy of functional, multifactorial interventions-such as exercise, environmental modifications, and comprehensive assessments-in mitigating fall risk ; Steady Strides Protocol includes utilizing multidisciplinary interventions using physical and occupational therapy providers working closely with physiatry providers and emphasizes close communication between the rehabilitation professionals to ensure optimal patient outcomes. Since functional deficits like self-care and gait or balance impairments are common in those with high fall risk ; Steady Strides Protocol involves functional medicine professionals: physiatrists (also know as physical medicine and rehabilitation, or PM\&R providers, mid-level and/or physician) to help evaluate and manage patient fall risk and barriers to rehabilitation, prescribe rehabilitation protocols and set rehabilitation-goals. Consistent with increased evidence that occupational therapy can help reduce falls ; Steady Strides protocol regularly promotes occupational therapy interventions. Since incorporating cognitive training together with physical therapy has been shown to reduce falls ; Steady Strides Protocol prescribes incorporating dual-tasking activities during rehabilitation. Since there is evidence that fear of falling is associated with increased fall risk ; Steady Strides Protocol systematically focuses on reducing fear of falling. To ensure consistency and reliability of care delivery Steady Strides Protocol uses a standardized hybrid on-line and in-person training for PM\&R clinicians and rehabilitation therapy providers. This course educates on how to perform a structured falls related history, physical exam, interventions and a how to set standardized set of rehabilitation goals in order to identify and treat chronic biomechanical factors contributing to increased fall risk. Steady Strides Protocol also focuses on increased patient engagement consistent with general good clinical practice, as well as in context of emerging evidence that patient engagement may reduce fall risk .
2. Rationale/Significance/Problem Statement

2.1 Rationale While the role of primary care providers in managing falls in older adults is crucial, investigators believe that fall prevention should primarily be managed by physicians trained in functional medicine, given that "medical reasons" are not the most common causes of falls. For example, one commonly thought of "medical reason" for falls, syncope, accounts for no more than 5% of falls in this population . Similarly, there is no strong association between falls and urinary tract infection, another commonly considered "medical reason" for falls in the elderly population. Whereas, by some estimates "mechanical falls," a term often used for "non-medical" causes, represent over 62% of falls among older adults presenting to emergency departments. Frequently reported causes of falls include slips, trips, and loss of balance, while factors often associated with falls include poor balance and difficulties with activities of daily living. Systematic reviews have consistently shown that functional, multifactorial interventions-such as exercise and environmental assessment and modification-are effective in preventing falls . It has been described that functional deficits, which serve as the final common pathway for various medical conditions, frequently constitute the majority of chronic predisposing risk factors for falls. These predisposing factors, such as gait and balance deficits, impaired vision, orthostatic hypotension, and impairments in cognitive function, Activity of Daily Living (ADLs), and Instrumental Activity of Daily Living (iADLs ), often play a significant role in increasing fall risk, with gait and balance problems frequently being the primary contributors. It therefore appears that functional deficits making up the final common pathway for different medical conditions often comprise the bulk of the chronic predisposing fall risk factors for falls . Given the strong evidence supporting functional medicine in fall prevention and the complexity of the neurological systems involved in balance and gait control , a biomechanical and functional assessment and treatment approach is preferred for managing older patients at risk of falls. Therefore, investigators advocate for a physiatrist-based approach for older adults at risk, as physiatrists specialize in functional medicine and the management of biomechanical impairments that affect human function, bridging functional and traditional medical approaches. Steady Strides is a structured, physiatrist-led, multifactorial functional assessment and management intervention. It combines a biomechanics-based functional physiatrist approach with comprehensive orthopedic, vestibular, podiatric, psychological, and neurological assessments to identify and treat the specific underlying biomechanical conditions that increase the risk of falls in older adults.

2.2 Significance Steady Strides protocol efficacy was demonstrated in a retrospective chart review observational cohort study , but there are no previously published physiatry-based randomized controlled studies of structured fall prevention interventions. This is the first structured physiatry-based randomized controlled study for preventing falls in community dwelling older adults. 3. Study Purpose and Objectives 3.1 Purpose Aim: Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) . This is a research study to evaluate the comparative effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard of care treatment in preventing falls in community-dwelling older adults. Current standard of care is for the primary care physicians to evaluate patients at risk of falls, order medical work up, specialist physician consultation(s), medication changes and other interventions as needed, and prescribe physical and/or occupational therapy. Widely publicized guidelines for primary care physicians managing older adults at risk of falls include the American Geriatrics Society and/or the Center for Disease Control and Prevention Stopping Elderly Accidents Deaths and Injuries (STEADI) guidelines. The intervention arm of the Steady Strides Protocol includes both standard care, that is follow up with the primary care and a structured physiatrist-led fall prevention program administered by licensed physical and occupational therapist providers with additional certification in utilizing the Steady Strides Fall Prevention Protocol. Physiatrist and therapist providers are trained using standardized hybrid in-person and online educational materials available at www.steadystridesacademy.com. This training is to standardize education and delivery of service of the Steady Strides Fall Prevention Protocol. Steady Strides Fall Prevention Protocol is not an experimental treatment and preliminary evidence from observational study with the protocol has shown good clinical outcomes.

3.2 Hypothesis: investigators hypothesize that participation in Steady Strides Fall Prevention Program will significantly reduce the number of falls compared to management by primary care providers as per standard of care.

3.3 Objectives

Primary Objective:

To evaluate the effectiveness of the Steady Strides protocol in reducing falls among community dwelling older adults six months after the intervention, specifically targeting individuals who have reported at least two falls in the previous six months.

Secondary Objectives: To evaluate the impact of the intervention on fall-related morbidity and mortality, the rate of hospitalizations, emergency department (ED) visits and other health-care utilization. To assess the impact of the intervention on reduction in fall rates from baseline; fall risk, ADLs, frailty, fear of falls, community integration, cognitive function, sleep and emotional well-being.