R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers

NCT ID: NCT05551143

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LiftKit Intervention

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).

Group Type EXPERIMENTAL

LiftKit

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LiftKit

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Working EMS providers

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steve Lavender

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LiftKit

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intradiscal Platelet Rich Plasma
NCT04544709 TERMINATED PHASE4