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Completed

NCT Number: NCT05359575

Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

St Louis, Missouri, 63130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understand spoken and written English.

Exclusion criteria

  • None

Treatment and study plan

Audio kit

Behavioral

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

Instructional flashcard (version 1)

Behavioral

Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.

In-person training

Behavioral

10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).

Instructional flashcard (version 2)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • LFR International
  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.