Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

Not Applicable

Completed

• Conditions: Cervical Vertebra Injury; Cervical Vertebra Fracture
• Interventions: Behavioral: Audio kit; Behavioral: Instructional flashcard (version 2); Behavioral: In-person training; Behavioral: Instructional flashcard (version 1)

• Registration Number: NCT05359575
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-04-23
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Understand spoken and written English.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up	Audio kit	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.
Instructional flashcard with cervical-collar - 2 months follow-up	Instructional flashcard (version 2)	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.
Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up	Instructional flashcard (version 2)	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.
In-person training with cervical-collar - 2 months follow-up	In-person training	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.
Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up	Instructional flashcard (version 2)	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.
Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up	Audio kit	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.
Instructional flashcard with cervical-collar - 1 month follow-up	Instructional flashcard (version 2)	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.
In-person training with cervical-collar - 1 month follow-up	In-person training	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.
Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up	Instructional flashcard (version 1)	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.
Instructional flashcard (version 1) with cervical-collar - no follow-up	Instructional flashcard (version 1)	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.
Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up	Audio kit	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 (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.
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.

Trial Locations

Locations (1)

Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering; 🇺🇸 Saint Louis, Missouri, United States