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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: $699,254.00
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
DUNS: 619142540
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 NECIP BERME
 (614) 944-9806
 berme@bertec.com
Business Contact
 JUDY KRASNIEWSKI
Phone: (614) 543-1129
Email: judy@bertec.com
Research Institution
 OHIO STATE UNIVERSITY
 1960 KENNY ROAD
COLUMBUS, OH, 43210-1016
 Nonprofit college or university
Abstract
Falls are a significant source of early morbidity and mortality in the aging populationyet the neurologicalsensoryand motor changes that lead to increased fall risk often escape early identification and interventionVital signs are commonly used in clinical settings to assess the cardiovascular systemblood pressureheart rateimmune systembody temperatureand the respiratory systemrespiratory rateto establish baseline values when initiating carescreen for increased risk of co morbidities or diseasesand allow for identification andcommunication of changes from baseline between health care professionals across time and locationsNo similar vital sign exists for assessing the balance systemwhich draws upon neurologicalsensory and motor functionsThereforethere is an urgent need for a balance vital sign in order to proactively catch declining balance health before an individual fallsIdeallythis test must be inexpensiveconsistentobjectiveeasy to adoptand proven sensitive and specific with regard to identifying an individual patient s risk of fallingGiven these designconsiderations and a growing evidence basequantitative postural control measurementqPCMstands out as the most viable candidate to serve as a standardized vital sign for balance healthOur 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 locationsPhase I SegmentAimDesign an inexpensiveeasy to use qPCM tool suitable for use by physiciansadvanced practice providersand medical assistants in busy clinic settingsusing theoretical frameworks for usability and implementation science to inform formative evaluation and stakeholder engagementMilestoneCompleted prototype of qPCM device and implementation toolkit that achieves high initial acceptance from end users and is ready to produce for efficacy testingPhase II SegmentAimAssess 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 settingUsing a randomized controlled design with randomization by clinic to receive the qPCM tool or use standard of caretest the hypotheses thataproviders will perceive that it influences their clinical decision making processandbproviders are more likely to recommend further evaluation or treatment for a balance deficit or fall risk when using the qPCM system than without itThe contribution of the proposed project is expected to be quantitative postural controlassessment and an implementation toolkit to align with workflow in the clinical environmentThis contribution will be significant because every patient could receive objectivequantitative postural control assessment at every office visitOur proposed research is innovative because it uses a stakeholder centered approach to create anevidence based assessment suitable of becoming avital signin the clinical setting and the requisiteimplementation toolkit to facilitate adoption and uptake of the assessmentWe also propose innovative methods to determine whether the assessment influences clinical decision making in practice The proposed research is relevant to public health because it would result in a balance vital sign to enable clinical providers to more proactively make informed decisions about patient care to prevent debilitating falls and the morbidity and mortality that followSuch a vital sign would support the National Institute of Aging s Strategic GoalsAUnderstand the sensory and motor changes associated with aging and how they lead to decreased functionandCDevelop improved approaches for the early detection and diagnosis of disabling illnesses and age related debilitating conditions

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

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