R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers
Primary Purpose
Musculoskeletal Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiftKit
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Disorder focused on measuring EMS, Ergonomics, Musculoskeletal Disorders, Back Injury, Firefighter
Eligibility Criteria
Inclusion Criteria:
- Working EMS providers
Exclusion Criteria:
- None
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LiftKit Intervention
Arm Description
All participants will have access to the LiftKit that provides them with a set of tools that should reduce the physical demands experienced by EMS providers when lifting and moving patients in their homes, thereby reducing the risk of musculoskeletal disorders (MSDs).
Outcomes
Primary Outcome Measures
Reported Musculoskeletal Injuries
Injuries that are due to patient handling tasks within the patient's home.
Secondary Outcome Measures
Usability, Usefulness, and Desirability of the tools within the LiftKit
Survey assessments
Full Information
NCT ID
NCT05551143
First Posted
September 19, 2022
Last Updated
September 19, 2022
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT05551143
Brief Title
R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers
Official Title
R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers Working in Urban, Suburban, and Rural Communities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The long-term goal of our research program is to reduce the high incidence of musculoskeletal injury associated with person-handling tasks performed by EMS providers/responders (NORA Public Safety Industry Sector). The literature shows the significant burden of these injuries, many of which affect the back and are debilitating. There is a need for effective ergonomic tools that can assist EMS providers in the patient handling tasks encountered in patient homes, particularly those patient handling situations that include restricted or tight spaces. To address this need, our prior work identified a set of potential ergonomic solutions, using a participatory process with EMS providers, for physically challenging and frequently occurring patient handling tasks that occur in patient homes. A final product of this prior work was the development of the LiftKit, which is a collection of seven tools that were shown in biomechanical validation studies with EMS providers to effectively reduce physical demands during simulated patient handling tasks in a laboratory setting. The overall objective of this proposed research-to-practice application is to evaluate the LiftKit's seven patient handling tools (interventions) in the field to assess their usability, usefulness, and desirability, as well as their impact with regards to preventing musculoskeletal injuries incurred during EMS patient handling tasks. In this field study, 30 LiftKits will be placed on EMS vehicles that service urban, suburban, and rural communities. Given the three-shift operation used by fire-service based EMS departments, there is the potential to recruit between 180 and 270 EMS providers for the study. Immediately following the training on how to use the tools and at 4, 8, and 12 months following the training, participants will be interviewed and questioned about each tools' usability, usefulness, and desirability. Frequency of each tool's use will be assessed with a questionnaire at the time of the interview and a daily Run-Use survey tool. Musculoskeletal injury data due to patient handling tasks during the 12 month follow-up period will be compared with injury data from the three-year period prior to study initiation. The final product of this work will provide the important evidence needed to widely promote the adoption of the ergonomic tools within the LiftKit, in order to reduce MSD injury risk to EMS providers associated with common patient handling tasks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorder
Keywords
EMS, Ergonomics, Musculoskeletal Disorders, Back Injury, Firefighter
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LiftKit Intervention
Arm Type
Experimental
Arm Description
All participants will have access to the LiftKit that provides them with a set of tools that should reduce the physical demands experienced by EMS providers when lifting and moving patients in their homes, thereby reducing the risk of musculoskeletal disorders (MSDs).
Intervention Type
Other
Intervention Name(s)
LiftKit
Intervention Description
The LiftKit contains 7 tools that could assist EMS providers when lifting/moving patients. These tools are:
Simple Strap - A sling to lift a seated patient
Strap and slide stick - A strap system for raising a supine patient to a sitting posture.
Slip Preventer- An envelope that goes over the patients feet with high friction straps for the EMS providers to stand on that prevent the patient from sliding forward when lifted.
Drag Straps - straps with handles that can be clipped on tarps used to drag patients
The Binder Lift - a vest with handles that allow EMS providers to easily get hold of patient they need to lift.
Patient Turning Straps - a way to log-roll a patient that in on the floor while in a standing posture.
The ELK - an inflatable seat cushion that can raise a patient who in the floor to chair level
Primary Outcome Measure Information:
Title
Reported Musculoskeletal Injuries
Description
Injuries that are due to patient handling tasks within the patient's home.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Usability, Usefulness, and Desirability of the tools within the LiftKit
Description
Survey assessments
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Working EMS providers
Exclusion Criteria:
None
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers
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