Clinical trial NCT05359575: Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople
Official title: Measuring the Effectiveness of Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Vertebra Injury
Cervical Vertebra Fracture
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: LFR International
First posted: 2022-05-04
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Understand spoken and written English.

Exclusion Criteria:

* None

Primary outcomes:
measure: Correct c-collar application
timeFrame: After initial intervention (up to 20 minutes)
measure: Knowledge retention of correct c-collar application at follow up (1 month)
timeFrame: 1 month
measure: Knowledge retention of correct c-collar application at follow up (2 months)
timeFrame: 2 months
Secondary outcomes:
measure: Level of Participant Confidence
timeFrame: After initial intervention (up to 20 minutes)
measure: Level of Participant Confidence (1 month)
timeFrame: 1 month
measure: Level of Participant Confidence (2 months)
timeFrame: 2 month
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering
state: Missouri
Study officials:
affiliation: Washington University in St. Louis - McKelvey School of Engineering
name: Patricia Widder
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Peter Delaney
role: STUDY_DIRECTOR
References: