Flooring for Injury Prevention Trial (FLIP)
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| ClinicalTrials.gov Identifier: NCT01618786 |
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Recruitment Status
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Active, not recruiting
First Posted
: June 13, 2012
Last Update Posted
: June 7, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Accidental Falls Bone Fracture Traumatic Brain Injury Head Injuries, Closed Nursing Homes | Other: SmartCell flooring Other: Plywood flooring | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 151 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | September 2013 |
| Estimated Primary Completion Date : | September 2017 |
| Estimated Study Completion Date : | September 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Compliant Flooring (CF)
Compliant flooring
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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.
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Placebo Comparator: Control (CON)
Non-compliant flooring
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Other: Plywood flooring
Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.
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- 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.
- 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.
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618786
| Canada, British Columbia | |
| New Vista Care Home | |
| Burnaby, British Columbia, Canada, V5E 3Z3 | |
| 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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) ) |
| First Posted: | June 13, 2012 Key Record Dates |
| Last Update Posted: | June 7, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Dr. Stephen Robinovitch, Simon Fraser University:
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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:
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Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Craniocerebral Trauma Fractures, Bone Head Injuries, Closed |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds, Nonpenetrating |