Standing Balance as the Fifth Vital Sign in Clinical Setting

Recruitment of clinics to participate in study. Study personnel will recruit clinics to participate in an 18-month trial of the quantitative postural control assessment (Balance+Weight) device. Eligible clinics include any that self-report a substantial component of their patient population that may be at risk of falls, but that are not a referral site for patients previously identified as being at elevated falls risk. In clinics where multiple providers see patients, at least one provider must be willing to participate and commit to placing the novel device in their clinic, as well as to the other components of participation detailed below. Due to the number of ambulatory care clinics within a radius to allow same-day servicing of the devices and resource limitations to manufacture units, the investigators will cap recruitment when the investigators reach 20 clinics or 60 devices in service, whichever is reached first. Every participating clinic will have the opportunity to receive the device that delivers Balance+Weight either immediately or after a 9-month waiting period depending on randomization.

Randomization of clinics. A block randomization scheme by clinic type will be used to assign which clinics receive the Balance+Weight device in the first 9 months and which clinics receive the Balance+Weight device in the second 9 months. The block randomization scheme is proposed instead of simple randomization because of the expected variation between clinics in the types of patients they see. Blocks will be determined based on the estimated percent of patients seen who are over 65, diabetic, undergoing chemotherapy (all oncology clinics), or are using assistive devices during some of their care (e.g. orthopaedic trauma clinics). Clinics for whom 50% or more of their patients are in any of these categories will be included in one block, whereas clinics for whom less than 50% of their patients are in any of these categories will be included in the other block. While this scheme does not fully account for the confounder of multiple risk factors for falls or multiple co-morbidities in some clinics, equipoise between treatment arms is also achieved through the crossover design whereby every clinic serves as its own control as well.

Training of clinics. At delivery of the Balance+Weight device to the clinic, a one-hour in-service will be performed by study personnel to train all providers and medical assistants on its proper use and the entry of data into the electronic medical record. This training will include how to operate the device and how to use the accompanying documentation with the reported data to inform clinical decision-making. This documentation will include threshold values for likelihood of the patient's balance being Within Normal Limits as well as the change in value that would indicate a change in the patient's balance status along with appendices that contain the published peer-reviewed journal articles upon which these recommendations are based. Upon request by the clinic, study personnel will repeat the training if refreshers are needed by clinic staff. An unlimited number of refresher trainings are permitted for each clinic, and the number of trainings requested per clinic will be recorded.

Incorporation of quantitative postural control assessment device into clinic flow including immediate feedback on clinical utility. Each participating clinic will place the study device in a location to allow its use instead of their weight scale. In the Balance+Weight arm, the device is capable of either just giving weight, or of providing balance data if the patient stands quietly with eyes closed for 30s. In the Weight Only arm, the device only gives a weight measurement, just as a standard weight scale would. In both cases, the provider and their staff make their own clinical decisions as to which patients to make measurements of and how to use the provided information. The medical assistant may choose to enter the appropriate values into the medical record and continue with any other standard procedures in that clinic setting as part of the rooming or initial evaluation process. The provider can then examine the recorded balance measurement along with their standard examination and determine whether any further evaluations in that clinic or referral to a specialist, physical therapy, or other falls prevention is appropriate and record that diagnosis or referral into the medical record.

Immediate feedback from provider on clinical decision-making process. After each patient encounter in which the provider assessed balance using the Balance+Weight device, the provider who made a clinical decision regarding balance or falls risk is asked to press a button on a small kiosk that the investigators will provide which logs their agreement with the statement, "The balance measurement influenced my clinical decision making with this patient." These kiosks from Happy-Or-Not.com are completely wireless and use their own 3G network to communicate the results of a single 4-point Likert scale question back to a central server that the study staff can monitor to collect data and get a real-time indication of whether the providers are using the Balance+Weight device.