Cervical Vertebra InjuryNCT05359575
Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople
A study testing Audio kit, Instructional flashcard (version 1) and In-person training in people with Cervical Vertebra Injury and Cervical Vertebra Fracture, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Vertebra Injury, Cervical Vertebra Fracture
- What is being tested?
- Audio kit, Instructional flashcard (version 1) and In-person training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand spoken and written English.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering
St Louis, Missouri, 63130
About this study
Official title: 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.
Read the 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.
- Being tested
- Audio kit, Instructional flashcard (version 1), In-person training, Instructional flashcard (version 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio kitBehavioural
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)Behavioural
Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application.
In-person trainingBehavioural
10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course).
Instructional flashcard (version 2)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Instructional flashcard (version 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct c-collar application
Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start7 Feb 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Vertebra InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, LFR International
- Responsible party
- Principal investigator, Jaimo Ahn, University of Michigan
- Investigators
- Patricia Widder, Study director, Washington University in St. Louis - McKelvey School of EngineeringPeter Delaney, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359575
- Sponsor's protocol ID
- HUM00210308
- Status last verified
- Jul 2022
- First submitted
- 23 Apr 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effectiveness of Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05359575
- Acronym / sponsor ID
- HUM00210308
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, LFR International
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up | Experimental | Behavioral: Audio kit, Behavioral: 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. |
| Instructional flashcard with cervical-collar - 1 month follow-up | Experimental | Behavioral: 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 | Experimental | Behavioral: In-person training10 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. |
| 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 | Behavioral: Audio kit, Behavioral: 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. |
| Instructional flashcard with cervical-collar - 2 months follow-up | Experimental | Behavioral: 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. |
| In-person training with cervical-collar - 2 months follow-up | Experimental | Behavioral: In-person training10 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. |
| 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 | Behavioral: Audio kit, Behavioral: 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 | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Understand spoken and written English.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio kitMP3 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 | Behavioural | 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)Single page with 7 pictures corresponding to each of the 6 steps of cervical collar (c-collar) application. | Behavioural | 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 training10 minute of an LFR spinal immobilization course (extracted from the current LFR Level 1 trauma course). | Behavioural | In-person training with cervical-collar - 1 month follow-up, In-person training with cervical-collar - 2 months follow-up |
| 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. | Behavioural | 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 |
Primary outcome
Correct c-collar application
Time frame: 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.
Knowledge retention of correct c-collar application at follow up (1 month)
Time frame: 1 month
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 (2 months)
Time frame: 2 months
Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.
3 secondary outcomes
Level of Participant Confidence
Time frame: After initial intervention (up to 20 minutes)
Level of Participant Confidence (1 month)
Time frame: 1 month
Level of Participant Confidence (2 months)
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Yes. Upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Widder study director
Washington University in St. Louis - McKelvey School of Engineering
Peter Delaney study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio kit, Instructional flashcard (version 1) and In-person training in people with Cervical Vertebra Injury and Cervical Vertebra Fracture, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct c-collar application (time frame: After initial intervention (up to 20 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.