HemorrhageSLAPSNCT05812352
Supporting Laypeople Addressing Prehospital Hemorrhage Study
A study testing Audio kit, Instructional flashcard and In-person training in people with Hemorrhage and Laceration, run by University of Michigan at 1 site in United States.
Trial summary
It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Laceration
- What is being tested?
- Audio kit, Instructional flashcard 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
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 1 Dec 2023
- 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 to 99 years
- 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: Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial
It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. 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 trauma burden, which disproportionately affects low- and middle-income countries (LMICs). With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs, called lay first responders (LFRs). In prospective studies of LFR activity across three sub-Saharan African countries comprising 2,039 total patient encounters, LFRs most frequently provided hemorrhage control in 61% of patient encounters. Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination, reducing mortality secondary to RTIs. Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence. Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies, decreasing preventable deaths by more than 50%. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application. Therefore, the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design.
- Conditions
- Hemorrhage, Laceration
- Being tested
- Audio kit, Instructional flashcard, In-person training
- Medical subject headings
- Hemorrhage, Lacerations
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 and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application
Instructional flashcardBehavioural
Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application
In-person trainingBehavioural
Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt
| Study group | Role | What they receive |
|---|---|---|
| Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up | Experimental | MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the audio kit at 6 month follow-up Receives: Behavioral: Audio kit |
| Instructional flashcard with tourniquet - 6 month follow-up | Experimental | Instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the instructional flashcard at 6 month follow-up Receives: Behavioral: Instructional flashcard |
| In-person training with tourniquet - 6 month follow-up | Experimental | Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt. Participants repeat the tourniquet application attempt without any POC instruction or re-training at 6 month follow-up Receives: Behavioral: In-person training |
| Control group with no in-person training and no point-of-care instruction access - 6 month follow-up | No intervention | There is no in-person training or point-of-care (POC) instructional interventions for this group for tourniquet application attempt. Participants repeat the tourniquet application attempt without any in-person training or POC instructional interventions at 6 month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct tourniquet application at initial encounter
Number of participants who meet all criteria for correct application of the tourniquet
Measured: After initial intervention (up to 20 minutes)
Correct tourniquet application at 6-month follow-up
Number of participants who meet all criteria for correct application of the tourniquet
Measured: 6 months
Secondary outcomes (2)
Level of Participant Confidence initially
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 at 6-month follow-up
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start24 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants are randomized to 1 of 4 educational interventions. Once the initial instructional intervention is completed, participants subsequently present for a 6-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 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, Zachary Eisner, University of Michigan
- Investigators
- Zachary Eisner, BS, Principal investigator, University of MichiganPatricia Widder, MS, Study director, Washington University in St. Louis - McKelvey School of Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812352
- Sponsor's protocol ID
- HUM00229966
- Acronym
- SLAPS
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2023
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05812352
- Acronym / sponsor ID
- SLAPS / HUM00229966
- Conditions
- Hemorrhage, Laceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, LFR International
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Apr 2023 (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 unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. 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 trauma burden, which disproportionately affects low- and middle-income countries (LMICs). With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs, called lay first responders (LFRs). In prospective studies of LFR activity across three sub-Saharan African countries comprising 2,039 total patient encounters, LFRs most frequently provided hemorrhage control in 61% of patient encounters. Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination, reducing mortality secondary to RTIs. Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence. Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies, decreasing preventable deaths by more than 50%. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application. Therefore, the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomized to 1 of 4 educational interventions. Once the initial instructional intervention is completed, participants subsequently present for a 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up | Experimental | Behavioral: Audio kitMP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the audio kit at 6 month follow-up |
| Instructional flashcard with tourniquet - 6 month follow-up | Experimental | Behavioral: Instructional flashcardInstructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the instructional flashcard at 6 month follow-up |
| In-person training with tourniquet - 6 month follow-up | Experimental | Behavioral: In-person trainingStop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt. Participants repeat the tourniquet application attempt without any POC instruction or re-training at 6 month follow-up |
| Control group with no in-person training and no point-of-care instruction access - 6 month follow-up | No intervention | –There is no in-person training or point-of-care (POC) instructional interventions for this group for tourniquet application attempt. Participants repeat the tourniquet application attempt without any in-person training or POC instructional interventions at 6 month follow-up |
Who may qualify
- Ages
- 18 to 99 years
- 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 and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application | Behavioural | Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up |
| Instructional flashcardSingle page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application | Behavioural | Instructional flashcard with tourniquet - 6 month follow-up |
| In-person trainingStop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt | Behavioural | In-person training with tourniquet - 6 month follow-up |
Primary outcome
Correct tourniquet application at initial encounter
Time frame: After initial intervention (up to 20 minutes)
Number of participants who meet all criteria for correct application of the tourniquet
Correct tourniquet application at 6-month follow-up
Time frame: 6 months
Number of participants who meet all criteria for correct application of the tourniquet
2 secondary outcomes
Level of Participant Confidence initially
Time frame: After initial intervention (up to 20 minutes)
Level of Participant Confidence at 6-month follow-up
Time frame: 6 months
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 13 Dec 2023.
- 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.
Zachary Eisner, BS principal investigator
University of Michigan
Patricia Widder, MS study director
Washington University in St. Louis - McKelvey School of Engineering
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 and In-person training in people with Hemorrhage and Laceration, 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 13 Dec 2023. 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 tourniquet application at initial encounter (time frame: After initial intervention (up to 20 minutes)). The study lists 2 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 13 Dec 2023.