Flooring for Injury Prevention Trial (FLIP)
Primary Purpose
Accidental Falls, Bone Fracture, Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SmartCell flooring
Plywood flooring
Sponsored by
About this trial
This is an interventional prevention trial for Accidental Falls focused on measuring Falls, Fall injuries, Bone fracture, Hip fracture, Skull fracture, Wounds, Closed head injury, Traumatic brain injury, Concussion, Spinal cord injury, Trauma, Older adults, Long-term care, Compliant flooring, Safety floors, Balance, Injury biomechanics, Biomedical engineering, Environmental hazards, Environmental interventions, Fall prevention, Gerontology
Eligibility Criteria
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
Sites / Locations
- New Vista Care Home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Compliant Flooring (CF)
Control (CON)
Arm Description
Compliant flooring
Non-compliant flooring
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Falls
Falls in resident rooms. Assessed from incident reports at participating long-term care facility.
Fractures
Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
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.
Musculoskeletal injuries
Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.
Full Information
NCT ID
NCT01618786
First Posted
June 11, 2012
Last Updated
May 3, 2022
Sponsor
Dr. Stephen Robinovitch
Collaborators
Canadian Institutes of Health Research (CIHR), AGE-WELL, Inc, Fraser Health Authority, Centre for Hip Health and Mobility, New Vista Society Care Home, Michael Smith Foundation for Health Research, Canada Research Chair Program, Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01618786
Brief Title
Flooring for Injury Prevention Trial
Acronym
FLIP
Official Title
Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Stephen Robinovitch
Collaborators
Canadian Institutes of Health Research (CIHR), AGE-WELL, Inc, Fraser Health Authority, Centre for Hip Health and Mobility, New Vista Society Care Home, Michael Smith Foundation for Health Research, Canada Research Chair Program, Natural Sciences and Engineering Research Council, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Bone Fracture, Traumatic Brain Injury, Head Injuries, Closed, Nursing Homes
Keywords
Falls, Fall injuries, Bone fracture, Hip fracture, Skull fracture, Wounds, Closed head injury, Traumatic brain injury, Concussion, Spinal cord injury, Trauma, Older adults, Long-term care, Compliant flooring, Safety floors, Balance, Injury biomechanics, Biomedical engineering, Environmental hazards, Environmental interventions, Fall prevention, Gerontology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compliant Flooring (CF)
Arm Type
Experimental
Arm Description
Compliant flooring
Arm Title
Control (CON)
Arm Type
Placebo Comparator
Arm Description
Non-compliant flooring
Intervention Type
Other
Intervention Name(s)
SmartCell flooring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plywood flooring
Intervention Description
Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.
Primary Outcome Measure Information:
Title
Fall-related injuries
Description
Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Falls
Description
Falls in resident rooms. Assessed from incident reports at participating long-term care facility.
Time Frame
4 years
Title
Fractures
Description
Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
Time Frame
4 years
Title
Health resource utilization
Description
Hospital transfers and admissions, emergency room visits, length of hospital stay, physician visits, physiotherapy and occupational therapy visits, nursing visits, diagnostic and lab procedures.
Time Frame
4 years
Title
Musculoskeletal injuries
Description
Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.
Time Frame
4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn C Mackey, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabio Feldman, PhD
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew C Laing, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen N Robinovitch, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Vista Care Home
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5E 3Z3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27044272
Citation
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.
Results Reference
background
PubMed Identifier
31233541
Citation
Mackey DC, Lachance CC, Wang PT, Feldman F, Laing AC, Leung PM, Hu XJ, Robinovitch SN. The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial. PLoS Med. 2019 Jun 24;16(6):e1002843. doi: 10.1371/journal.pmed.1002843. eCollection 2019 Jun.
Results Reference
derived
Links:
URL
http://www.sfu.ca/tips
Description
Technology for Injury Prevention in Seniors (TIPS)
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Flooring for Injury Prevention Trial
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