Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

NCT05359575 | Completed

• 1 other identifier: HUM00210308
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Vertebra Injury; Cervical Vertebra Fracture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Level of Participant Confidence

  After initial intervention (up to 20 minutes)

• Level of Participant Confidence (1 month)

  1 month

• Level of Participant Confidence (2 months)

  2 month

Study Arms (10)

Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up

EXPERIMENTAL

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; Behavioral: Instructional flashcard (version 2)

Instructional flashcard with cervical-collar - 1 month follow-up

EXPERIMENTAL

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)

In-person training with cervical-collar - 1 month follow-up

EXPERIMENTAL

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

Control group with no in-person training and no access to POC instruction - 1 month follow-up

NO INTERVENTION

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.

Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up

EXPERIMENTAL

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; Behavioral: Instructional flashcard (version 2)

Instructional flashcard with cervical-collar - 2 months follow-up

EXPERIMENTAL

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)

In-person training with cervical-collar - 2 months follow-up

EXPERIMENTAL

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

Control group with no in-person training and no access to POC instruction - 2 months follow-up

NO INTERVENTION

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.

Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up

EXPERIMENTAL

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; Behavioral: Instructional flashcard (version 1)

Instructional flashcard (version 1) with cervical-collar - no follow-up

EXPERIMENTAL

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)

Interventions

Audio kit BEHAVIORAL

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

Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up; Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up; Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up

Instructional flashcard (version 1) BEHAVIORAL

Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.

Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up; Instructional flashcard (version 1) with cervical-collar - no follow-up

In-person training BEHAVIORAL

10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).

In-person training with cervical-collar - 1 month follow-up; In-person training with cervical-collar - 2 months follow-up

Instructional flashcard (version 2) BEHAVIORAL

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.

Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up; Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up; Instructional flashcard with cervical-collar - 1 month follow-up; Instructional flashcard with cervical-collar - 2 months follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand spoken and written English.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Michigan: lead
• Washington University School of Medicine: collaborator
• LFR International: collaborator

Study Sites (1)

Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

St Louis, Missouri, 63130, United States

Location

Study Officials

• Patricia Widder

  Washington University in St. Louis - McKelvey School of Engineering

  STUDY DIRECTOR

• Peter Delaney

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harold W. and Helen L. Gehring Research Professor of Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 4, 2022
• Study Start: February 7, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 18 months of completion of primary outcome measures.

Locations

US (1)