Clinical trial NCT04139642: Standing Balance as the Fifth Vital Sign in Clinical Setting
Official title: Standing Balance as the Fifth Vital Sign in Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Fall
Postural Balance
Clinical Decision-making
Keywords: descriptive observational study
balance measurement
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Bertec Corporation
name: National Institute on Aging (NIA)
First posted: 2019-10-25
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include physicians, advanced practice registered nurses, and physician assistants who diagnose and treat patients in ambulatory outpatient settings. Participants must commit to using the test device as the primary weight scale in the clinic for the duration of the study to be selected. Participants will be identified through word-of-mouth and email announcements distributed by the organizations listed above. Any additional organizations that express interest will also be encouraged to distribute announcements to their employees.

Brief summary: This 18-month prospective, observational study involving real world data will determine if the use of a standing scale that delivers a quantitative measure of standing balance along with weight (balance + weight) in place of a scale that only delivers weight (weight only) influences clinical decision making by health care practitioners in the ambulatory outpatient setting. Providers will be randomized to receive the balance+weight scale or weight-only scale for 9 months, then to crossover and receive the other for 9 months. The primary outcome measures are (1) providers' self-reported perceptions of whether the balance measurement influences their clinical decision making and (2) the rate of performing falls risk assessments or referring to a specialist for evaluation and treatment based on aggregate billing data. The secondary outcome measure is qualitative interviews with practitioners regarding their perceptions on the utility and barriers to using the device.

Detailed description: 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.

Crossover of sites after 9 months. At the 9-month point, study personnel will go to every site to reprogram each device from Balance+Weight mode to Weight Only mode or vice versa, and to move the immediate feedback kiosks to the new Balance+Weight sites.

Data pull of clinic-level diagnosis and referral data. At or just after the crossover between sites has occurred, study personnel in conjunction with the IT departments at participating sites will pull the clinic diagnosis and referral data for all participating providers. After Casey et al.\[1\], our initial plan is to count instances of the following Common Procedural Terminology (CPT) Category II codes:

(Primary) CPT II 3288: Assessment of falls risk CPT II 0518: Development of a falls care plan CPT II 1101: Documentation of falls in past year (no falls/ single fall without injury) CPT II 1100: Documentation of an injurious fall/ multiple falls Other referral codes as appropriate Because CPT codes are updated each calendar year, the investigators will review the new codes each year and revise this code list as new codes related to falls assessment are added or subtracted. The investigators will pull this data from both the 9 months of participation in the study, as well as the same 9 month period in the calendar year before the study began as a historical control. The data will be pulled again upon completion of the study for the second 9-month period.

Focus group discussions after completion of RCT. Following conclusion of the trial, The investigators will engage all participants in focus groups regarding their experience using the Balance+Weight device. These discussions are intended to complement and enrich our understanding of how the users of the device (providers and medical assistants) either benefitted or did not benefit from having it in the clinic. Feedback will be used to assess the implementation toolkit and inform the development of the final version of the toolkit. Seed questions for these focus groups include:

In what ways, if any, did participants find having a quantitative postural control assessment on every patient useful in their clinical decision making? If participants applied the device's data differently for different patients, how did participants use it across these different patients? Did the time it took to make the measurement or interpret the measurement impact the efficiency of their clinic (positively or negatively) and how? In what ways could the investigators better implement and train participants to use the device, and use it with the electronic medical record?

Eligibility criteria: Inclusion Criteria:

* Columbus Metropolitan Area by the following counties: Franklin, Madison, Union, Delaware, Locking, Fairfield, Pickaway.
* Physician, advanced practice registered nurse, or physician assistant, who diagnoses and treats patients in ambulatory outpatient settings
* self-report that falls are a concern for a significant fraction of the participant's patients, where the participants defines significant as they see fit.
* Participants must commit to using the test device as the primary weight scale in the clinic for the duration of the study to be selected.

Exclusion Criteria:

* No gender, ethnic, or racial groups will be excluded from this study, though it is expected that the majority of the sample will be Caucasian American, given that the professions of physicians, nurse practitioners, and physician assistants are predominantly Caucasian American.

Primary outcomes:
measure: Percentage of Balance-Related Diagnoses
timeFrame: Historical control period plus 18-month intervention period
measure: Number of Unique Visits With and Without Balance-Related Referrals
timeFrame: at conclusion of second intervention period (18 months)
measure: Providers' Perceptions Reported as Number of Responses
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
citation: Casey CM, Parker EM, Winkler G, Liu X, Lambert GH, Eckstrom E. Lessons Learned From Implementing CDC's STEADI Falls Prevention Algorithm in Primary Care. Gerontologist. 2017 Aug;57(4):787-796. doi: 10.1093/geront/gnw074. Epub 2016 Apr 29.