- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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).
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: S.Ariane Christie, BA, MD
- Numer telefonu: 808-430-9678
- E-mail: s.ariane.christie@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Isaac Obeng-Gyasi, MBChB, MPH
- Numer telefonu: 202-500-4230
- E-mail: iobeng@mednet.ucla.edu
Lokalizacje studiów
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Southwest
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Limbe, Southwest, Kamerun
- Limbe Health District
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Kontakt:
- Frida E Nganje, MD, MPH
- Numer telefonu: +237676641543
- E-mail: fridaembolo@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nielosowe
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: 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.
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Eksperymentalny: 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.
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Training of LFR providers using a data driven, pretested curriculum adapted for the Cameroon context over a 3-month training and transition period.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Prehospital care rate
Ramy czasowe: 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.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Systolic blood pressure at presentation
Ramy czasowe: 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
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From enrollment through the 18-month post implementation period.
|
|
Respiratory rate greater than 8 and less than 20 breaths per minute
Ramy czasowe: 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.
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From enrollment through the 18-month post-implementation period
|
|
Proportion of trauma patients with heart rate between 60 and 100 beats per minute
Ramy czasowe: 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.
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From enrollment through the 18-month post implementation period.
|
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In-hospital mortality
Ramy czasowe: From enrollment through the 18-month post-implementation period.
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All-cause in-hospital mortality among injured patients, compared between pre- and post implementation LFR cohorts.
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From enrollment through the 18-month post-implementation period.
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24-hour mortality
Ramy czasowe: From enrollment through the 18-month post implementation period.
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All-cause mortality within 24 hours of hospital presentation among injured patients, compared between pre- and post implementation LFR cohorts.
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From enrollment through the 18-month post implementation period.
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Blood transfusion
Ramy czasowe: From enrollment through 18-month post implementation period.
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Proportion of injured patients receiving blood transfusion during hospitalization, compared between pre- and post implementation LFR cohorts.
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From enrollment through 18-month post implementation period.
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Operative intervention
Ramy czasowe: 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.
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- K01TW012689 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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