We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Flooring for Injury Prevention Trial (FLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01618786
Recruitment Status : Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 11, 2012
June 13, 2012
June 7, 2017
September 2013
September 2017   (Final data collection date for primary outcome measure)
Fall-related injuries [ Time Frame: 4 years ]
Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
Same as current
Complete list of historical versions of study NCT01618786 on ClinicalTrials.gov Archive Site
  • Falls [ Time Frame: 4 years ]
    Falls in resident rooms. Assessed from incident reports at participating long-term care facility.
  • Fractures [ Time Frame: 4 years ]
    Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
  • Health resource utilization [ Time Frame: 4 years ]
    Hospital transfers and admissions, emergency room visits, length of hospital stay, physician visits, physiotherapy and occupational therapy visits, nursing visits, diagnostic and lab procedures.
  • Musculoskeletal injuries [ Time Frame: 4 years ]
    Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.
Same as current
Not Provided
Not Provided
 
Flooring for Injury Prevention Trial
Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Accidental Falls
  • Bone Fracture
  • Traumatic Brain Injury
  • Head Injuries, Closed
  • Nursing Homes
  • 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.
  • Other: Plywood flooring
    Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.
  • Experimental: Compliant Flooring (CF)
    Compliant flooring
    Intervention: Other: SmartCell flooring
  • Placebo Comparator: Control (CON)
    Non-compliant flooring
    Intervention: Other: Plywood flooring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
151
September 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01618786
TIPS-001
TIR 103945 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
Yes
Not Provided
Plan to Share IPD: Undecided
Dr. Stephen Robinovitch, Simon Fraser University
Dr. Stephen Robinovitch
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Dawn C Mackey, PhD Simon Fraser University
Principal Investigator: Fabio Feldman, PhD Fraser Health Authority
Principal Investigator: Andrew C Laing, PhD University of Waterloo
Principal Investigator: Stephen N Robinovitch, PhD Simon Fraser University
Simon Fraser University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP