Trial Outcomes & Findings for Testing the Effectiveness of a Falls Prevention System (NCT NCT03678402)
NCT ID: NCT03678402
Last Updated: 2024-07-12
Results Overview
To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology \[PUP™ \]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
521 participants
Primary outcome timeframe
hospital stay (on average 5 days)
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
Palarum Fall Prevention System
The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.
PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.
|
|---|---|
|
Overall Study
STARTED
|
521
|
|
Overall Study
COMPLETED
|
521
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Effectiveness of a Falls Prevention System
Baseline characteristics by cohort
| Measure |
Palarum Fall Prevention System
n=521 Participants
The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.
PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
425 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
96 Participants
n=93 Participants
|
|
Age, Continuous
|
59.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
521 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: hospital stay (on average 5 days)To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology \[PUP™ \]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.
Outcome measures
| Measure |
Palarum Fall Prevention System
n=521 Participants
The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.
PUP™ sock: The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.
|
|---|---|
|
High Risk Fall Rate
|
0 falls/1000 patient days
|
Adverse Events
Palarum Fall Prevention System
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
Dr. Tammy Moore
The Ohio State University Wexner Medical Center
Phone: 6142937847
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place