NCT05359575

Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Cervical Vertebra Injury
• Cervical Vertebra Fracture

Interventions

Type	Name	Description
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.
BEHAVIORAL	In-person training	10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
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.

Timeline

• Start date: 2022-02-07
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2022-05-04
• Last updated: 2022-07-27

Locations

1 site across 1 country: United States