Clinical trial NCT05812352: Supporting Laypeople Addressing Prehospital Hemorrhage Study
Official title: Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Laceration
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: LFR International
First posted: 2023-04-13
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Understand spoken and written English

Exclusion Criteria:

* None

Primary outcomes:
measure: Correct tourniquet application at initial encounter
timeFrame: After initial intervention (up to 20 minutes)
measure: Correct tourniquet application at 6-month follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Level of Participant Confidence initially
timeFrame: After initial intervention (up to 20 minutes)
measure: Level of Participant Confidence at 6-month follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering
state: Missouri
Study officials:
affiliation: University of Michigan
name: Zachary Eisner, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University in St. Louis - McKelvey School of Engineering
name: Patricia Widder, MS
role: STUDY_DIRECTOR
References: