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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Vertebra Injury; Cervical Vertebra Fracture
• Intervention / Treatment: Behavioral: Audio kit; Behavioral: Instructional flashcard (version 2); Behavioral: In-person training; Behavioral: Instructional flashcard (version 1)

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 Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Understand spoken and written English.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up; 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.	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 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.
Experimental: Instructional flashcard with cervical-collar - 1 month follow-up; 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.	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.
Experimental: In-person training with cervical-collar - 1 month follow-up; 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.	Behavioral: In-person training; 10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
No Intervention: Control group with no in-person training and no access to POC instruction - 1 month follow-up; There is no in-person training or point-of-care (POC) instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 1 month follow-up.
Experimental: Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up; 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.	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 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.
Experimental: Instructional flashcard with cervical-collar - 2 months follow-up; 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.	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.
Experimental: In-person training with cervical-collar - 2 months follow-up; 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.	Behavioral: In-person training; 10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
No Intervention: Control group with no in-person training and no access to POC instruction - 2 months follow-up; There is no in-person training or POC instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 2 months follow-up.
Experimental: Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up; 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.	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.
Experimental: Instructional flashcard (version 1) with cervical-collar - no follow-up; 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.	Behavioral: Instructional flashcard (version 1); Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct c-collar application	Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.	After initial intervention (up to 20 minutes)
Knowledge retention of correct c-collar application at follow up (1 month)	Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.	1 month
Knowledge retention of correct c-collar application at follow up (2 months)	Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Participant Confidence	Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.	After initial intervention (up to 20 minutes)
Level of Participant Confidence (1 month)	Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.	1 month
Level of Participant Confidence (2 months)	Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident.	2 month

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Washington University School of Medicine; LFR International
• Investigators: Study Director: Patricia Widder, Washington University in St. Louis - McKelvey School of Engineering; Study Director: Peter Delaney, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HUM00210308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request to the corresponding author.
• IPD Sharing Time Frame: Within 18 months of completion of primary outcome measures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No