Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

July 25, 2022 updated by: Jaimo Ahn, University of Michigan

Measuring the Effectiveness of Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople: A Randomized Clinical Trial

It is not known if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Road traffic injuries (RTIs) are the largest contributor to the global injury burden, which disproportionately affects low- and middle-income countries (LMICs). Traumatic spinal cord injury (TSCI) is the highest contributor to years lived disabled (YLDs) resulting from RTIs, accounting for 74.8% of YLDs from RTI. With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs. Early spinal immobilization has the potential to limit neurological deficits secondary to TSCI and morbidity. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators and tourniquets. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design. The POC instructional flashcard was first piloted with an initial cohort of participants who were not assigned to any longitudinal follow-up date to pilot POC instructional interventions for c-spine immobilization and receive feedback for instructional flashcard revision prior to launching the "trial." Data from these participants is not considered part of the "trial" for analytic purposes. This entire testing process is with participants who are healthy volunteers and researchers simulating spinal injury victims to test which method of instruction is most effective and durable for understanding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
265

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Understand spoken and written English.

Exclusion Criteria:

  • None

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up
MP3 audio files for each of 6 steps (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the audio kit at 1 month follow-up.
Behavioral: Audio kit
MP3 audio files for each of 6 steps of c-collar application (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application
Behavioral: Instructional flashcard (version 2)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application edited for clarity based on initial pilot feedback.
Experimental: Instructional flashcard with cervical-collar - 1 month follow-up
Instructional flashcard with seven pictures corresponding to 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the instructional flashcard at 1 month follow-up.
Behavioral: Instructional flashcard (version 2)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application edited for clarity based on initial pilot feedback.
Experimental: In-person training with cervical-collar - 1 month follow-up
10 minutes of a Lay First Responder (LFR) spinal immobilization course (extracted from the current LFR Level 1 trauma course) are used for instruction for c-collar application attempt. Participants repeat the c-collar application without any POC instruction or re-training at 1 month follow-up.
Behavioral: In-person training
10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
No Intervention: Control group with no in-person training and no access to POC instruction - 1 month follow-up
There is no in-person training or point-of-care (POC) instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 1 month follow-up.
Experimental: Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up
MP3 audio files for each of 6 steps (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the audio kit at 2 months follow-up.
Behavioral: Audio kit
MP3 audio files for each of 6 steps of c-collar application (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application
Behavioral: Instructional flashcard (version 2)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application edited for clarity based on initial pilot feedback.
Experimental: Instructional flashcard with cervical-collar - 2 months follow-up
Instructional flashcard with seven pictures corresponding to 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the instructional flashcard at 2 months follow-up.
Behavioral: Instructional flashcard (version 2)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application edited for clarity based on initial pilot feedback.
Experimental: In-person training with cervical-collar - 2 months follow-up
10 minutes of a Lay First Responder (LFR) spinal immobilization course (extracted from the current LFR Level 1 trauma course) are used for instruction for c-collar application attempt. Participants repeat the c-collar application without any POC instruction or re-training at 2 months follow-up.
Behavioral: In-person training
10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
No Intervention: Control group with no in-person training and no access to POC instruction - 2 months follow-up
There is no in-person training or POC instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 2 months follow-up.
Experimental: Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up
Prior to randomization to 1 or 2 month follow up, these participants served as an initial cohort of participants who were not assigned to any longitudinal follow-up date so that the POC instructional flashcard could first be piloted to receive feedback for instructional flashcard revision prior to launching the "trial" after participants expressed concern about ambiguity in the instructional flashcard. Data from these participants is not considered part of the "trial" for any analytic purposes. Revisions to the instructional flashcard were made.
Behavioral: Audio kit
MP3 audio files for each of 6 steps of c-collar application (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application
Behavioral: Instructional flashcard (version 1)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.
Experimental: Instructional flashcard (version 1) with cervical-collar - no follow-up
Prior to randomization to 1 or 2 month follow up, these participants served as an initial cohort of participants who were not assigned to any longitudinal follow-up date so that the POC instructional flashcard could first be piloted to receive feedback for instructional flashcard revision prior to launching the "trial" after participants expressed concern about ambiguity in the instructional flashcard. Data from these participants is not considered part of the "trial" for any analytic purposes. Revisions to the instructional flashcard were made.
Behavioral: Instructional flashcard (version 1)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correct c-collar application
Time Frame: After initial intervention (up to 20 minutes)
Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.
After initial intervention (up to 20 minutes)
Knowledge retention of correct c-collar application at follow up (1 month)
Time Frame: 1 month
Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.
1 month
Knowledge retention of correct c-collar application at follow up (2 months)
Time Frame: 2 months
Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of Participant Confidence
Time Frame: After initial intervention (up to 20 minutes)
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.
After initial intervention (up to 20 minutes)
Level of Participant Confidence (1 month)
Time Frame: 1 month
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.
1 month
Level of Participant Confidence (2 months)
Time Frame: 2 month
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.
2 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Washington University School of Medicine
LFR International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patricia Widder, Washington University in St. Louis - McKelvey School of Engineering
  • Study Director: Peter Delaney, University of Michigan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00210308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request to the corresponding author.

IPD Sharing Time Frame

Within 18 months of completion of primary outcome measures.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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