Clinical trial NCT03876496: Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
Official title: A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fall From Bed
Keywords: fall prevention
bed fall
acute care
patient safety
patient monitoring
health technology assessment
sensor devices and platforms
nursing
Lead sponsor: MedicusTek USA Corporation
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2019-03-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.

This study has three specific aims:

1. To assess the comfort of the system when used with hospitalized patients;
2. To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
3. To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.


Eligibility criteria: Inclusion Criteria:

* Gender: male or female
* Age: 18 years and older
* Racial and ethnic origin: all ethnic groups
* Hospital status: admitted in-patient or a patient under observation
* Expected hospital length of stay: minimum of 23 hours
* Willingness to participate in the study
* Moderate to High fall risk scoring a 2 or greater on the Mobility or Mental/LOC/Awareness status sections of the Hester Davis Fall Risk Assessment.

Exclusion Criteria:

* Declined to participate
* Patients less than 18 years old
* Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
* Women who are documented as pregnant during the study period
* Patients who are medically unstable; as per the discretion of the primary nurse
* Patients who are actively in the dying process, at the discretion of the primary nurse

Primary outcomes:
measure: % of Nursing Staff Who Want to Use the System Following the Trial
timeFrame: focus group at week 8 within the 13 week study period
measure: % of Nursing Staff Who Want to Use the System Following the Trial
timeFrame: focus group at week 12 within the 13 week study period
Secondary outcomes:
measure: Rate of Bed Falls Decreased Over Study Period
timeFrame: through the 13 week study period
Other outcomes:
Locations:
city: Downey
country: United States
facility: Downey Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Jerry Spicer
role: PRINCIPAL_INVESTIGATOR
References: