NCT05551143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 19, 2022

Last Update Submit

September 19, 2022

Conditions

Keywords

EMSErgonomicsMusculoskeletal DisordersBack InjuryFirefighter

Outcome Measures

Primary Outcomes (1)

  • Reported Musculoskeletal Injuries

    Injuries that are due to patient handling tasks within the patient's home.

    12 months

Secondary Outcomes (1)

  • Usability, Usefulness, and Desirability of the tools within the LiftKit

    12 months

Study Arms (1)

LiftKit Intervention

EXPERIMENTAL

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).

Other: LiftKit

Interventions

LiftKitOTHER

The LiftKit contains 7 tools that could assist EMS providers when lifting/moving patients. These tools are: 1. Simple Strap - A sling to lift a seated patient 2. Strap and slide stick - A strap system for raising a supine patient to a sitting posture. 3. 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. 4. Drag Straps - straps with handles that can be clipped on tarps used to drag patients 5. The Binder Lift - a vest with handles that allow EMS providers to easily get hold of patient they need to lift. 6. Patient Turning Straps - a way to log-roll a patient that in on the floor while in a standing posture. 7. The ELK - an inflatable seat cushion that can raise a patient who in the floor to chair level

LiftKit Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working EMS providers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesBack Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 22, 2022

Study Start

October 1, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations