Clinical trial NCT01618786: Flooring for Injury Prevention Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: AGE-WELL, Inc
name: Fraser Health Authority
name: Centre for Hip Health and Mobility
name: New Vista Society Care Home
name: Michael Smith Foundation for Health Research
name: Canada Research Chair Program
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2012-06-13
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fall-related injuries
timeFrame: 4 years
Secondary outcomes:
measure: Falls
timeFrame: 4 years
measure: Fractures
timeFrame: 4 years
measure: Health resource utilization
timeFrame: 4 years
measure: Musculoskeletal injuries
timeFrame: 4 years
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: New Vista Care Home
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Dawn C Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fraser Health Authority
name: Fabio Feldman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Andrew C Laing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Simon Fraser University
name: Stephen N Robinovitch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.