Trial Outcomes & Findings for Standing Balance as the Fifth Vital Sign in Clinical Setting (NCT NCT04139642)
NCT ID: NCT04139642
Last Updated: 2023-10-25
Results Overview
Percent of unique visits with a balance-related diagnosis
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
Historical control period plus 18-month intervention period
Results posted on
2023-10-25
Participant Flow
Eligible clinics include any in the Columbus Ohio Metropolitan Area 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. The investigators planned to cap recruitment when the investigators reach 20 clinics or 60 devices in service, whichever is reached first.
A total of 3 participants were never assigned. Of these excluded particpants, 2 were lost to follow-up and 1 never received the intervention device due to moving to a different clinic and not notifying the study.
Unit of analysis: clinics
Participant milestones
| Measure |
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 (AB) and which clinics receive the Balance+Weight device in the second 9 months (BA). 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. The historical control time period for all participants includes a 12-month period before the beginning of the first intervention, from March 2019-February 2020. The first intervention period went from November 2020-July 2021, and the second intervention period went from August 2021-April 2022.
SimpleSway: During 9-month A period participants provide anonymous feedback via a kiosk with four marked buttons indicating a 4-point Likert Scale. Participant presses button to indicate agreement with 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 second 9-month period all devices are retrieved, and participants complete surveys and attend group feedback sessions regarding their experiences.
|
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 (AB) and which clinics receive the Balance+Weight device in the second 9 months (BA). 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. The historical control time period for all participants includes a 12-month period before the beginning of the first intervention, from March 2019-February 2020. The first intervention period went from November 2020-July 2021, and the second intervention period went from August 2021-April 2022.
SimpleSway: During 9-month A period participants provide anonymous feedback via a kiosk with four marked buttons indicating a 4-point Likert Scale. Participant presses button to indicate agreement with 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 second 9-month period all devices are retrieved, and participants complete surveys and attend group feedback sessions regarding their experiences.
|
|---|---|---|
|
Historical Control Period (12 Months)
STARTED
|
20 8
|
22 8
|
|
Historical Control Period (12 Months)
COMPLETED
|
20 8
|
22 8
|
|
Historical Control Period (12 Months)
NOT COMPLETED
|
0 0
|
0 0
|
|
First Intervention (9 Months)
STARTED
|
20 8
|
22 8
|
|
First Intervention (9 Months)
COMPLETED
|
20 8
|
21 7
|
|
First Intervention (9 Months)
NOT COMPLETED
|
0 0
|
1 1
|
|
Second Intervention (9 Months)
STARTED
|
20 8
|
21 7
|
|
Second Intervention (9 Months)
COMPLETED
|
20 8
|
21 7
|
|
Second Intervention (9 Months)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
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 (AB) and which clinics receive the Balance+Weight device in the second 9 months (BA). 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. The historical control time period for all participants includes a 12-month period before the beginning of the first intervention, from March 2019-February 2020. The first intervention period went from November 2020-July 2021, and the second intervention period went from August 2021-April 2022.
SimpleSway: During 9-month A period participants provide anonymous feedback via a kiosk with four marked buttons indicating a 4-point Likert Scale. Participant presses button to indicate agreement with 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 second 9-month period all devices are retrieved, and participants complete surveys and attend group feedback sessions regarding their experiences.
|
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 (AB) and which clinics receive the Balance+Weight device in the second 9 months (BA). 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. The historical control time period for all participants includes a 12-month period before the beginning of the first intervention, from March 2019-February 2020. The first intervention period went from November 2020-July 2021, and the second intervention period went from August 2021-April 2022.
SimpleSway: During 9-month A period participants provide anonymous feedback via a kiosk with four marked buttons indicating a 4-point Likert Scale. Participant presses button to indicate agreement with 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 second 9-month period all devices are retrieved, and participants complete surveys and attend group feedback sessions regarding their experiences.
|
|---|---|---|
|
First Intervention (9 Months)
Permission denied to use the device by clinic manager
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group AB
n=20 Participants
Participants who received the Balance+Weight device during the First Intervention Period (9 months), then the Weight Only device during the Second Intervention Period (9 months).
|
Group BA
n=21 Participants
Participants who received the Weight Only device during the First Intervention Period (9 months), then the Balance+Weight device during the Second Intervention Period (9 months).
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Sex/Gender, Customized
Man
|
12 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
20 Participants
n=41 Participants
|
|
Sex/Gender, Customized
Woman
|
8 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
21 Participants
n=41 Participants
|
|
Sex/Gender, Customized
Gender-Fluid or Non-Binary
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Degree or Credential
Medical Doctor
|
20 Participants
n=20 Participants
|
14 Participants
n=21 Participants
|
34 Participants
n=41 Participants
|
|
Degree or Credential
Doctor of Osteopathy
|
0 Participants
n=20 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=41 Participants
|
|
Degree or Credential
Certified Nurse Practitioner
|
0 Participants
n=20 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=41 Participants
|
|
Degree or Credential
Physician Assistant
|
0 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Historical control period plus 18-month intervention periodPopulation: All unique in-person visits by patients to the providers who participated in the study
Percent of unique visits with a balance-related diagnosis
Outcome measures
| Measure |
A: Balance+Weight
n=41726 unique visits
Participants during the 9-month that they had the Balance+Weight device available in their clinic.
|
B: Weight-Only
n=38236 unique visits
Participants during the 9-month period when they had a device that only reports weight.
|
Historical Control
n=69224 unique visits
Participants during the historical period March 2019-February 2020 before the intervention began
|
|---|---|---|---|
|
Percentage of Balance-Related Diagnoses
|
12118 unique visits
|
11763 unique visits
|
19904 unique visits
|
PRIMARY outcome
Timeframe: at conclusion of second intervention period (18 months)Population: Physicians and advanced-practice providers who were granted access to the intervention device to use with their patients according to their clinical judgment.
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.
Outcome measures
| Measure |
A: Balance+Weight
n=41726 unique visits
Participants during the 9-month that they had the Balance+Weight device available in their clinic.
|
B: Weight-Only
n=38236 unique visits
Participants during the 9-month period when they had a device that only reports weight.
|
Historical Control
n=69224 unique visits
Participants during the historical period March 2019-February 2020 before the intervention began
|
|---|---|---|---|
|
Number of Unique Visits With and Without Balance-Related Referrals
visits with balance-related referral
|
474 unique visits
|
479 unique visits
|
1145 unique visits
|
|
Number of Unique Visits With and Without Balance-Related Referrals
visits without balance-related referral
|
41252 unique visits
|
37757 unique visits
|
68079 unique visits
|
PRIMARY outcome
Timeframe: through study completion, an average of 18 monthsPopulation: During the time in which they had a balance device (intervention A), all participants had access to a device that would record an instantaneous momentary assessment of their agreement with the statement, "The balance device influenced my clinical decision-making today." The statement is irrelevant when a balance device was not present, so this outcome only is collected when they had the Balance+Weight device, regardless of group assignment.
Providers' self-reported perceptions of whether the balance measurement influences their clinical decision making.
Outcome measures
| Measure |
A: Balance+Weight
n=361 Responses
Participants during the 9-month that they had the Balance+Weight device available in their clinic.
|
B: Weight-Only
n=1073 Responses
Participants during the 9-month period when they had a device that only reports weight.
|
Historical Control
Participants during the historical period March 2019-February 2020 before the intervention began
|
|---|---|---|---|
|
Providers' Perceptions Reported as Number of Responses
Very Positive
|
117 responses
|
347 responses
|
—
|
|
Providers' Perceptions Reported as Number of Responses
Somewhat Positive
|
115 responses
|
455 responses
|
—
|
|
Providers' Perceptions Reported as Number of Responses
Somewhat Negative
|
47 responses
|
226 responses
|
—
|
|
Providers' Perceptions Reported as Number of Responses
Very Negative
|
82 responses
|
45 responses
|
—
|
Adverse Events
Balance+Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Weight Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place