- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581327
Data-Driven Lay First Responder Program in Cameroon (K-LFR Project)
Implementation of a Data-Driven Pre-Hospital Lay First Responder Program in Cameroon
Cameroon experiences a high burden of injury-related morbidity and mortality and currently lacks a formal pre-hospital care system. Lay First Responder (LFR) programs have been implemented in several low-and middle-income countries to improve early injury care by training non-medical community members with high exposure to injury, such as commercial drivers, in basic first aid and safe transport of injured patients.
The study aims to implement and evaluate a data-driven, context-adapted LFR program in Cameroon using an implementation science approach. Quantitative trauma registry data and qualitative stakeholder interviews will be used to adapt the LFR curriculum to local injury patterns and care gaps. LFR program implementation will be associated with increased chances of survival on presentation and improved trauma outcomes.
The study is an interrupted time series evaluation of an LFR intervention where prehospital care rates and clinical patterns in the Cameroon Trauma Registry (CTR) patients at Limbe Regional hospital will be compared between historical pre-implementation controls and post-implementation of a data-driven lay first responder training program (the intervention).
Study Overview
Status
Intervention / Treatment
Detailed Description
Injury accounts for a substantial proportion of preventable mortality in Cameroon, where no organized prehospital emergency medical system currently exists. Evidence suggests that effective prehospital care could prevent up to 45% of injury-related deaths. Lay First Responder (LFR) programs represent a pragmatic strategy for improving early trauma care in resource-limited settings by training lay persons who are frequently present at injury scenes.
Despite promising early results in other settings, rigorous evaluation of LFR programs has been limited, particularly regarding their impact on patient-level outcomes. This study aim to test the contextual feasibility of the lay first responder program in Cameroon, after it has been successful in other Sub-Saharan nations.
This study seeks to address these gaps by implementing a data-driven LFR program informed by trauma registry analysis and stakeholder engagement, and by evaluating feasibility, acceptability, and effectiveness within Cameroonian context.
The Cameroon Trauma Registry (CTR) gathers prospective data on patient demographics, injury characteristics, receipt of prehospital care, clinical findings and management, disposition and outcomes on patients admitted for injuries at ten trauma hospitals in Cameroon. Each hospital has a full-time research assistant overseen by an MPH-level field supervisor. Patients are followed from presentation through hospital discharge. This study will be implemented in Limbe municipality, Cameroon and will utilize data from the Limbe Regional Hospital site of the CTR.
The LFR intervention: An LFR curriculum adapted for the Cameroon context using a two-stage, mixed-methods approach (quantitative analysis of prospective CTR data and qualitative semi-structured interviews of target stakeholders) will be used to train LFR providers (commercial drivers and community members) over a 3-month training and transition period.
The primary metric of program feasibility will be percent change in the proportion of trauma patients receiving prehospital care in the post-intervention cohort compared to pre-intervention historical controls. The secondary outcomes for program effectiveness will be injury severity-stratified percentage change in the proportion of CTR patients presenting with normal vital signs (systolic blood pressure, heart rate, respiratory rate) in the post-intervention cohort compared to the pre-intervention cohort.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: S.Ariane Christie, BA, MD
- Phone Number: 808-430-9678
- Email: s.ariane.christie@gmail.com
Study Contact Backup
- Name: Isaac Obeng-Gyasi, MBChB, MPH
- Phone Number: 202-500-4230
- Email: iobeng@mednet.ucla.edu
Study Locations
-
-
Southwest
-
Limbe, Southwest, Cameroon
- Limbe Health District
-
Contact:
- Frida E Nganje, MD, MPH
- Phone Number: +237676641543
- Email: fridaembolo@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Trauma patients presenting to Limbe Regional Hospital and enrolled in the Cameroon Trauma Registry
Exclusion Criteria
- Trauma patients not included in the Cameroon trauma registry at Limbe regional hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-LFR implementation CTR cohort
Historic data of trauma patients enrolled during an 18-month pre-implementation period in Limbe Regional Hospital before the LFR training program commences.
|
|
|
Experimental: Post-LFR implementation CTR cohort
Trauma patients enrolled in the 18- month post-implementation period in Limbe Regional Hospital after the 3-month LFR provider training program and transition period has ended.
|
Training of LFR providers using a data driven, pretested curriculum adapted for the Cameroon context over a 3-month training and transition period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prehospital care rate
Time Frame: From enrollment through the 18-month post implementation period.
|
Proportion of hospitalized trauma patients who received prehospital care prior to arrival at participating hospitals, compared between pre- and post implementation LFR cohorts.
|
From enrollment through the 18-month post implementation period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure at presentation
Time Frame: From enrollment through the 18-month post implementation period.
|
Median systolic blood pressure (mmHg) measured at hospital presentation among injured patients, compared between pre- and post implementation LFR cohorts
|
From enrollment through the 18-month post implementation period.
|
|
Respiratory rate greater than 8 and less than 20 breaths per minute
Time Frame: From enrollment through the 18-month post-implementation period
|
Percentage change in the proportion of CTR patients presenting with respiratory rate greater than 8 and less than 20 breaths per minute compared between pre- and post implementation LFR cohorts.
|
From enrollment through the 18-month post-implementation period
|
|
Proportion of trauma patients with heart rate between 60 and 100 beats per minute
Time Frame: From enrollment through the 18-month post implementation period.
|
Percent change in the proportion of trauma patients with heart rate between 60 and 100 beats per minute compared between pre- and post implementation LFR cohorts.
|
From enrollment through the 18-month post implementation period.
|
|
In-hospital mortality
Time Frame: From enrollment through the 18-month post-implementation period.
|
All-cause in-hospital mortality among injured patients, compared between pre- and post implementation LFR cohorts.
|
From enrollment through the 18-month post-implementation period.
|
|
24-hour mortality
Time Frame: From enrollment through the 18-month post implementation period.
|
All-cause mortality within 24 hours of hospital presentation among injured patients, compared between pre- and post implementation LFR cohorts.
|
From enrollment through the 18-month post implementation period.
|
|
Blood transfusion
Time Frame: From enrollment through 18-month post implementation period.
|
Proportion of injured patients receiving blood transfusion during hospitalization, compared between pre- and post implementation LFR cohorts.
|
From enrollment through 18-month post implementation period.
|
|
Operative intervention
Time Frame: From enrollment through 18-month post implementation period.
|
Proportion of injured patients requiring surgical intervention during hospitalization, compared between pre- and post implementation LFR cohorts.
|
From enrollment through 18-month post implementation period.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01TW012689 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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