Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2022-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CT C-spine Audit and Feedback

NCT05711134

Cervical Spine Injury Emergencies Trauma

COMPLETED NA

Evaluation of the Nursing C-Spine (Phase IV)

NCT01353352

Fracture of Cervical Spine Fracture Dislocation of Cervical Spine

COMPLETED PHASE4

Evaluation of Splinting in Tetraplegia

NCT04523636

Spinal Cord Injury Cervical Splints

COMPLETED NA

The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.

NCT02356380

Neck Pain

UNKNOWN NA

Thoracic Spine Manipulation for Individuals With Low Back Pain

NCT02853357

Low Back Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Vertebra Injury Cervical Vertebra Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Audio kit

Intervention Type 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

Instructional flashcard (version 2)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Instructional flashcard (version 2)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

In-person training

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Audio kit

Intervention Type 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

Instructional flashcard (version 2)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Instructional flashcard (version 2)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

In-person training

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Audio kit

Intervention Type 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

Instructional flashcard (version 1)

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Instructional flashcard (version 1)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Instructional flashcard (version 1)

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

Intervention Type BEHAVIORAL

In-person training

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

Intervention Type 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.

Intervention Type BEHAVIORAL