Sensable®Care System: Establishing a Communications System for Patient Fall Reduction

A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction

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.

Study Overview

• Status: Completed
• Conditions: Fall From Bed
• Intervention / Treatment: Device: SensableCare System

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Downey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SensableCareCare System; 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 the unit.

Device: SensableCare System; The Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively. Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented.; Other Names: MedicusTek

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Nursing Staff Who Want to Use the System Following the Trial	Acceptance of SensableCare System after Trial Period	focus group at week 8 within the 13 week study period
% of Nursing Staff Who Want to Use the System Following the Trial	Acceptance of SensableCare System after Trial Period	focus group at week 12 within the 13 week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Bed Falls Decreased Over Study Period	Whether bed falls had decreased over the study period compared to before the start of the trial	through the 13 week study period

Collaborators and Investigators

• Sponsor: MedicusTek USA Corporation
• Collaborators: Kaiser Permanente
• Investigators: Principal Investigator: Jerry Spicer, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2017
• Primary Completion (Actual): October 21, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: nursing; patient safety; fall prevention; acute care; patient monitoring; health technology assessment; bed fall; sensor devices and platforms
• Other Study ID Numbers: Kaiser Downey CTA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No