Flooring for Injury Prevention Trial

Traumatic Brain Injury Clinical Trial

— FLIP  

Official title:

Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618786
• Other study ID #: TIPS-001
• Secondary ID: TIR 103945
• Status: Completed
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: August 2019

Study information

• Verified date: January 2019
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families. The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.

Description:

Falls are the number one cause of unintentional injury among older adults in Canada, and are responsible for economic costs in excess of $1 billion CAD annually. In high-risk environments, such as long-term care (LTC) facilities, 60% of residents will experience at least one fall each year. Moreover, approximately 30% of falls in LTC residents result in injury, and 3 to 5% cause fractures. A promising strategy for reducing the incidence of fall-related injuries in LTC facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. Purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). Yet, few LTC facilities have flooring designed to reduce the impact of falls. This study will address this gap. Resident rooms at a local LTC facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. Following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. In addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. Perceptions about compliant flooring will be assessed among staff, residents, and their families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 2019
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria (for rooms):

• Resident rooms across four units at New Vista Society Care Home, a long-term care facility in Burnaby, BC, Canada

Exclusion Criteria (for rooms):

• Resident rooms across four units at New Vista Society Care Home in which new flooring cannot be installed

Related Conditions & MeSH terms

• Accidental Falls
• Bone Fracture
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Fractures, Bone
• Head Injuries, Closed
• Nursing Homes
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• SmartCell flooring
SmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements.
• Plywood flooring
Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.

Locations

Country	Name	City	State
Canada	New Vista Care Home	Burnaby	British Columbia

Sponsors (9)

Lead Sponsor	Collaborator
Dr. Stephen Robinovitch	AGE-WELL, Inc, Canada Research Chair Program, Canadian Institutes of Health Research (CIHR), Centre for Hip Health and Mobility, Fraser Health Authority, Michael Smith Foundation for Health Research, Natural Sciences and Engineering Research Council, Canada, New Vista Society Care Home

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lachance CC, Feldman F, Laing AC, Leung PM, Robinovitch SN, Mackey DC. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care. Inj Prev. 2016 Dec;22(6):453-460. doi: 10.1136/injuryprev-2016-042008. Epub 2016 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall-related injuries	Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.	4 years
Secondary	Falls	Falls in resident rooms. Assessed from incident reports at participating long-term care facility.	4 years
Secondary	Fractures	Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.	4 years
Secondary	Health resource utilization	Hospital transfers and admissions, emergency room visits, length of hospital stay, physician visits, physiotherapy and occupational therapy visits, nursing visits, diagnostic and lab procedures.	4 years
Secondary	Musculoskeletal injuries	Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.	4 years

External Links

•   Technology for Injury Prevention in Seniors (TIPS)