Standing Balance as the Fifth Vital Sign in Clinical Setting

NCT04139642 | Completed Results

• 2 other identifiers: 2019H0265R42AG062065-02
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Fall; Postural Balance; Clinical Decision-making

Keywords

descriptive observational study; balance measurement

Outcome Measures

Primary Outcomes (3)

• Percentage of Balance-Related Diagnoses

  Percent of unique visits with a balance-related diagnosis

  Historical control period plus 18-month intervention period

• Number of Unique Visits With and Without Balance-Related Referrals

  Difference in the rate of performing falls risk assessments or referring to a specialist for evaluation and treatment based on aggregate billing data when the provider has the device versus when the provider does not have the device.

  at conclusion of second intervention period (18 months)

• Providers' Perceptions Reported as Number of Responses

  Providers' self-reported perceptions of whether the balance measurement influences their clinical decision making.

  through study completion, an average of 18 months

Study Arms (2)

Group AB

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. At the 9-month point, OSU 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.

Device: SimpleSway

Group BA

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. At the 9-month point, OSU 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.

Device: SimpleSway

Interventions

SimpleSway DEVICE

During the 9-month period each practitioner who receives the balance + weight device is asked to provide anonymous feedback via a kiosk regarding if the balance data influenced clinical decision making after every patient. The kiosk has four marked buttons indicating a 4-point Likert Scale, so the practitioner just presses one of the four buttons to indicate their agreement with the statement, "The balance measurement influenced my clinical decision making with this patient." After 9 months, the devices are switched so that every practitioner who had a weight only device receives balance + weight device and vice versa. After the second 9-month period concludes all devices will be retrieved by study personnel, and participants will be asked to complete surveys regarding their experience and attend group feedback sessions regarding their experiences.

Group AB; Group BA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Bertec Corporation: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43021, United States

Location

Related Publications (1)

• 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.

  PMID: 27130270 RESULT

Limitations and Caveats

Intervention was likely affected by the COVID-19 pandemic affecting both volume and characteristics of the patients visiting the clinics of the providers who participated in the study. Several provider participants noted in post-intervention focus groups that they were unable to implement the intervention device into their clinical workflow due to pandemic-related workforce shortages and turnover.

Results Point of Contact

• Title: Dr. Ajit Chaudhari
• Organization: The Ohio State University

chaudhari.2@osu.edu

+1-614-292-0558

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy, Orthopaedics, Mechanical Engineering, and Biomedical Engineering

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: March 2, 2020
• Primary Completion: April 30, 2022
• Study Completion: August 31, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)