Clinical trial NCT03678402: Testing the Effectiveness of a Falls Prevention System
Official title: Testing the Effectiveness of a Falls Prevention System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk for Falling
Keywords: falling
inpatient
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm prospective non-randomized study
Primary purpose: PREVENTION

Brief summary: The purpose of this single arm intervention study is 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 PUP™ \[Patient is UP Falls Prevention System\] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital.

Detailed description: The purpose of this single arm intervention study is 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 PUP™ \[Patient is UP Falls Prevention System\] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.

Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older;
* All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.

Exclusion Criteria:

* Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.

Primary outcomes:
measure: High Risk Fall Rate
timeFrame: hospital stay (on average 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tammy Moore, RN, PHD
role: PRINCIPAL_INVESTIGATOR
References: