Flooring for Injury Prevention Trial (FLIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fraser Health Authority
New Vista Society Care Home
Information provided by (Responsible Party):
Dr. Stephen Robinovitch, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01618786
First received: June 11, 2012
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Accidental Falls
Bone Fracture
Traumatic Brain Injury
Head Injuries, Closed
Nursing Homes
Other: SmartCell flooring
Other: Plywood flooring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Fall-related injuries [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Falls in resident rooms. Assessed from incident reports at participating long-term care facility.

  • Fractures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.

  • Health resource utilization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.


Estimated Enrollment: 151
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compliant Flooring (CF)
Compliant flooring
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.
Placebo Comparator: Control (CON)
Non-compliant flooring
Other: Plywood flooring
Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618786

Locations
Canada, British Columbia
New Vista Care Home
Burnaby, British Columbia, Canada, V5E 3Z3
Sponsors and Collaborators
Dr. Stephen Robinovitch
Canadian Institutes of Health Research (CIHR)
Fraser Health Authority
New Vista Society Care Home
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Stephen Robinovitch, Professor, Department of Biomedical Physiology and Kinesiology, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01618786     History of Changes
Other Study ID Numbers: TIPS-001, TIR 103945
Study First Received: June 11, 2012
Last Updated: April 5, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Simon Fraser University:
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

Additional relevant MeSH terms:
Fractures, Bone
Craniocerebral Trauma
Head Injuries, Closed
Brain Injuries
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds, Nonpenetrating
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014