Cervical Vertebra Fracture, Cervical Vertebra Injury
Conditions
Brief 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.
Interventions
BEHAVIORALAudio 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
BEHAVIORALInstructional flashcard (version 1)
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.
BEHAVIORALIn-person training
10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
BEHAVIORALInstructional 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.
Sponsors
Washington University School of Medicine
LFR International
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor only enters the laboratory after the participant has attempted to apply the cervical collar (c-collar). Therefore, the outcomes assessor is unaware of the instructional intervention that was employed. The outcomes assessor will collect cervical range of motion (CROM) measurements using a CROM device to verify correct c-collar placement by evaluating whether the c-collar was appropriately sized and if neck movement is restricted in five cardinal directions: flexion, extension, and bidirectional rotation.
Intervention model description
Participants are initially randomized to 1 of 4 arms. Once the initial instructional intervention is completed, participants are subsequently randomized to either a 1-month or 2-month follow-up. Participants initially randomized to the two arms with flashcards (v. 1) are not randomized to either follow up, because version 1 of the flash cards was confusing and thus was piloted with these initial participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Understand spoken and written English.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct c-collar application | 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. |
| Knowledge retention of correct c-collar application at follow up (1 month) | 1 month | Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar. |
| Knowledge retention of correct c-collar application at follow up (2 months) | 2 months | Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Participant Confidence | 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. |
| Level of Participant Confidence (1 month) | 1 month | Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident. |
| Level of Participant Confidence (2 months) | 2 month | Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident. |
Countries
United States
Outcome results
None listed