Flooring for Injury Prevention Trial (FLIP)

May 3, 2022 updated by: Dr. Stephen Robinovitch

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5E 3Z3
        • New Vista Care Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 4 years
Falls in resident rooms. Assessed from incident reports at participating long-term care facility.
4 years
Fractures
Time Frame: 4 years
Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
4 years
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.
4 years
Musculoskeletal injuries
Time Frame: 4 years
Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Stephen Robinovitch

Collaborators

Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
Michael Smith Foundation for Health Research
AGE-WELL, Inc
Fraser Health Authority
Centre for Hip Health and Mobility
New Vista Society Care Home
Canada Research Chair Program

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

August 31, 2017

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIPS-001
  • TIR 103945 (OTHER_GRANT: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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