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Making Standing Balance The Fifth Vital Sign in Clinical Settings

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42AG062065-02
Agency Tracking Number: R42AG062065
Amount: $1,337,717.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PA18-576
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-15
Award End Date (Contract End Date): 2021-08-31
Small Business Information
6171 HUNTLEY RD STE J
Columbus, OH 43229-1047
United States
DUNS: 619142540
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 NECIP BERME
 (614) 944-9806
 berme@bertec.com
Business Contact
 JUDITH KRASNIEWSKI
Phone: (614) 562-5271
Email: judy@bertec.com
Research Institution
 OHIO STATE UNIVERSITY
 
1960 KENNY ROAD
COLUMBUS, OH 43210-1016
United States

 Nonprofit college or university
Abstract

Falls are a significant source of early morbidity and mortality in the aging population, yet the neurological,sensory, and motor changes that lead to increased fall risk often escape early identification and intervention. Vital
signs are commonly used in clinical settings to assess the cardiovascular system (blood pressure, heart rate),
immune system (body temperature), and the respiratory system (respiratory rate) to establish baseline values
when initiating care, screen for increased risk of co-morbidities or diseases, and allow for identification andcommunication of changes from baseline between health care professionals across time and locations. No similar
vital sign exists for assessing the balance system, which draws upon neurological, sensory and motor functions.
Therefore, there is an urgent need for a balance vital sign in order to proactively catch declining balance health
before an individual falls. Ideally, this test must be inexpensive, consistent, objective, easy to adopt, and proven
sensitive and specific with regard to identifying an individual patient’s risk of falling. Given these designconsiderations and a growing evidence base, quantitative postural control measurement (qPCM) stands out as the
most viable candidate to serve as a standardized vital sign for balance health. Our long term goal is theimplementation of qPCM as a vital sign in primary care and other clinical settings to track balance health among
individual patients over time and across clinical locations. Phase I Segment - Aim 1: Design an inexpensive,
easy-to-use qPCM tool suitable for use by physicians, advanced practice providers, and medical assistants in
busy clinic settings, using theoretical frameworks for usability and implementation science to inform formative
evaluation and stakeholder engagement. Milestone: Completed prototype of qPCM device and implementation
toolkit that achieves high initial acceptance from end users and is ready to produce for efficacy testing. Phase II
Segment - Aim 2: Assess the initial efficacy of qPCM to better identify patients with a significant decline in
balance relative to the standard history and physical exam in the clinical setting. Using a randomized controlled
design with randomization by clinic to receive the qPCM tool or use standard of care, test the hypotheses that
(a) providers will perceive that it influences their clinical decision-making process, and (b) providers are more
likely to recommend further evaluation or treatment for a balance deficit or fall risk when using the qPCM system
than without it. The contribution of the proposed project is expected to be quantitative postural controlassessment and an implementation toolkit to align with workflow in the clinical environment. This contribution will be
significant because every patient could receive objective, quantitative postural control assessment at every office
visit. Our proposed research is innovative because it uses a stakeholder-centered approach to create anevidence-based assessment suitable of becoming a “vital sign” in the clinical setting and the requisiteimplementation toolkit to facilitate adoption and uptake of the assessment. We also propose innovative methods to determine
whether the assessment influences clinical decision making in practice.

* Information listed above is at the time of submission. *

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