- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07677449
Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon
Implementation of a Culturally Adapted Alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) Program in Cameroon
**Brief Summary**
Alcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in Cameroon. This study aims to evaluate a Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for trauma patients at the Limbe Regional Hospital.
The study will be conducted in three phases: (1) training emergency department healthcare providers on a culturally adapted SBIRT program; (2) evaluating the feasibility, acceptability, and fidelity of SBIRT implementation in routine emergency care; and (3) assessing the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients. Healthcare workers will be trained to deliver SBIRT, and eligible trauma patients screening positive for risky alcohol use will be enrolled in a randomized waitlist-controlled trial. Participants will undergo alcohol screening using validated tools and will be followed for six months. Outcomes will include alcohol use measured by the Alcohol Use Disorders Identification Test (AUDIT), phosphatidylethanol (PEth) biomarker levels, referral uptake, implementation outcomes, and patient well-being measures.
The study is expected to generate evidence on the feasibility and effectiveness of integrating alcohol interventions into trauma care in a low-resource setting and inform future scale-up of SBIRT programs in Cameroon and similar settings.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
**Detailed Description**
Alcohol use is a major contributor to the burden of injury in Cameroon and other low- and middle-income countries (LMICs). Studies conducted in Cameroon have demonstrated high levels of alcohol use among road users and trauma patients, with substantial proportions of injured patients reporting recent alcohol consumption or testing positive for alcohol at the time of injury. Harmful alcohol use is associated with increased risk of injury, injury recurrence, disability, and mortality. Despite this burden, systematic alcohol screening and intervention services are not routinely integrated into trauma care in Cameroon.
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach designed to identify individuals with risky alcohol use, provide brief counseling to promote behavior change, and facilitate referral to treatment when indicated. SBIRT has been successfully implemented in emergency departments and trauma centers in high-income countries and has demonstrated effectiveness in reducing harmful alcohol use and alcohol-related consequences. However, little is known about the feasibility, acceptability, and effectiveness of SBIRT in resource-constrained emergency care settings in sub-Saharan Africa.
The purpose of this study is to evaluate a Cameroon-adapted SBIRT program implemented within the Emergency Department of the Limbe Regional Hospital. The intervention was developed through a participatory adaptation process involving emergency department clinicians, mental health providers, trauma researchers, implementation scientists, and other stakeholders to ensure cultural appropriateness and operational feasibility within the Cameroonian healthcare context.
The study has three primary objectives: (1) to train emergency department healthcare providers in delivery of a Cameroon-adapted SBIRT program; (2) to evaluate the feasibility, acceptability, adoption, and fidelity of SBIRT implementation in routine emergency care; and (3) to evaluate the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients.
The study will be conducted in phases. During the preparatory phase, stakeholders will be engaged to refine implementation procedures and pretest the training curriculum. Emergency department healthcare workers, including physicians, nurses, and mental health nurses, will then undergo structured training on alcohol screening, motivational interviewing, brief intervention delivery, and referral procedures. Following training, a transition period will be used to integrate SBIRT into routine emergency department operations and optimize implementation workflows before initiation of full study enrollment.
All eligible adult trauma patients presenting to the Emergency Department will be screened for alcohol use using the Single Alcohol Screening Question (SASQ). Patients reporting alcohol use will complete the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). Men with AUDIT-C scores of 4 or greater and women with AUDIT-C scores of 3 or greater will be considered positive for risky alcohol use and eligible for study enrollment. Participants will subsequently complete the full Alcohol Use Disorders Identification Test (AUDIT) for characterization of alcohol use severity. Individuals with AUDIT scores of 8 or greater will be referred for additional evaluation and treatment according to the study referral protocol.
Eligible participants will be randomized to either an intervention arm or a waitlist-control arm. Participants assigned to the intervention arm will receive the Cameroon-adapted SBIRT program delivered by trained healthcare workers during their emergency department visit. The intervention consists of alcohol risk screening, personalized feedback regarding alcohol use, a brief motivational interviewing-based counseling session, and referral to treatment when indicated. Participants assigned to the waitlist-control arm will receive usual care during the study period and will be offered the intervention following completion of study follow-up.
Participants will be followed for six months following enrollment. Follow-up assessments will occur at one month, three months, and six months after enrollment. Alcohol use outcomes will be assessed using both self-reported and biological measures. Self-reported alcohol use will be measured using the AUDIT instrument. Biological alcohol use will be assessed using phosphatidylethanol (PEth), a validated biomarker of recent alcohol consumption. Additional outcomes will include referral uptake, treatment engagement, depression symptoms measured using the Patient Health Questionnaire-9 (PHQ-9), and injury-related outcomes.
Implementation outcomes will be evaluated using implementation science frameworks including the Consolidated Framework for Implementation Research (CFIR), Proctor's Implementation Outcomes Framework, and the FRAMES model. Feasibility, acceptability, fidelity, adoption, and implementation determinants will be assessed through implementation monitoring, provider surveys, direct observation of intervention delivery, and qualitative interviews with healthcare workers and patients.
The primary hypothesis is that the Cameroon-adapted SBIRT program can be feasibly integrated into routine emergency department care and that participants receiving the intervention will demonstrate greater reductions in harmful alcohol use over six months compared with participants receiving usual care. The study will generate evidence regarding implementation strategies, intervention effectiveness, and scalability of alcohol interventions in trauma care settings within LMICs.
Results from this study are expected to inform future implementation and scale-up of SBIRT programs in Cameroon and other resource-limited settings. The findings may also provide implementation insights relevant to underserved trauma systems and emergency care settings globally where access to behavioral health and substance use services remains limited.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Serge Ngekeng, PhD in Public Health
- Telefonszám: +237675652562
- E-mail: sergengekeng@gmail.com
Tanulmányi helyek
-
-
South-West Region
-
Limbe, South-West Region, Kamerun, 00237
- Limbe Regional Hospital
-
Kapcsolatba lépni:
- Serge Ngekeng, PhD in public Health
- Telefonszám: 675652562
- E-mail: sergengekeng@gmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Adult trauma patients aged 18 years and older presenting to the Emergency Department of Limbe Regional Hospital.
- Positive alcohol screening based on the Single Alcohol Screening Question (SASQ).
- AUDIT-C score ≥4 for men or ≥3 for women.
- Able to provide informed consent.
- Resident within the study catchment area and available for follow-up.
- Access to a telephone or another reliable means of contact for follow-up assessments.
Exclusion Criteria:
- Severe cognitive impairment preventing participation in study procedures or - provision of informed consent.
- Severe traumatic brain injury or other medical condition requiring immediate life-saving intervention that precludes participation.
- Current psychosis or severe psychiatric illness preventing meaningful participation in the intervention.
- In police custody or other circumstances limiting ability to participate in follow-up.
- Planned relocation outside the study catchment area during the study follow-up period.
- Previously enrolled in the study.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Immediate SBIRT
Participants receive the Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program during their emergency department visit.
The intervention includes alcohol screening, personalized feedback, a brief motivational interviewing-based counseling session, and referral to treatment when indicated.
|
A culturally adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program delivered by trained emergency department healthcare workers.
The intervention includes alcohol risk screening, brief motivational interviewing-based counseling, and referral to treatment when appropriate.
|
|
Aktív összehasonlító: Waitlist Control
Participants receive usual care during the follow-up period and are offered the SBIRT intervention after completion of the six-month follow-up assessment.
|
Standard emergency department care without structured SBIRT delivery during the study follow-up period.
Participants are offered SBIRT after completing six months of follow-up.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Alcohol Use at 6 Months
Időkeret: Baseline and 6 months
|
Change in harmful alcohol use from baseline to 6 months following enrollment, measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
|
Baseline and 6 months
|
|
Change in Phosphatidylethanol (PEth) Levels
Időkeret: Baseline and 6 months
|
Change in alcohol consumption measured using phosphatidylethanol (PEth), a biomarker of recent alcohol use, from baseline to 6 months.
|
Baseline and 6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Alcohol Use at 1 Month
Időkeret: 1 month
|
Change in Alcohol Use Measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score at 1 month following enrollment.
The total score ranges from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous or harmful drinking.
|
1 month
|
|
Alcohol Use at 3 Months
Időkeret: 3 Months
|
Change in Alcohol Use Measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score at 3 month following enrollment.
The total score ranges from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous or harmful drinking.
|
3 Months
|
|
PEth Levels at 1 Month
Időkeret: 1 Month
|
PEth concentration at 1 month following enrollment.
|
1 Month
|
|
PEth Levels at 3 months
Időkeret: 3 month
|
PEth concentration at 3 month following enrollment.
|
3 month
|
|
Referral Uptake
Időkeret: Within 6 months
|
Proportion of participants referred for additional alcohol treatment services who attend at least one referral appointment.
|
Within 6 months
|
|
Depressive Symptoms
Időkeret: Baseline, 1 month, 3 months, and 6 months
|
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated nine-item self-report questionnaire that measures the severity of depressive symptoms over the preceding two weeks.
The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms
|
Baseline, 1 month, 3 months, and 6 months
|
|
SBIRT Delivery Rate
Időkeret: Through study completion, an average of 36 months.
|
Proportion of eligible participants who receive all components of the SBIRT intervention.
|
Through study completion, an average of 36 months.
|
|
Intervention Fidelity
Időkeret: Through study completion, an average of 36 months.
|
Adherence of healthcare workers to SBIRT delivery protocols assessed using structured fidelity checklists.
|
Through study completion, an average of 36 months.
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Serge Ngekeng, PhD in Public Health, University of Buea
Publikációk és hasznos linkek
Általános kiadványok
- Babor TF, Del Boca F, Bray JW. Screening, Brief Intervention and Referral to Treatment: implications of SAMHSA's SBIRT initiative for substance abuse policy and practice. Addiction. 2017 Feb;112 Suppl 2:110-117. doi: 10.1111/add.13675.
- Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
- Ngekeng S, Kibu O, Oke R, Bassah N, Touko DA, Yost MT, Dissak-Delon F, Tendongfor N, Nguefack-Tsague G, Hubbard A, McCoy SI, Christie SA, Chichom-Mefire A, Juillard C. Prehospital factors associated with mortality among road traffic injury patients: analysis of Cameroon trauma registry data. BMC Emerg Med. 2024 Oct 16;24(1):194. doi: 10.1186/s12873-024-01113-8.
- Ngekeng S, Oke R, Yost M, Dissak-Delon F, Hubbard A, McCoy SI, Christie A, Shoptaw S, Chichom-Mefire A, Juillard C. Prevalence and Factors Associated With Alcohol-Related Road Traffic Injuries in Cameroon. J Surg Res. 2024 Oct;302:116-124. doi: 10.1016/j.jss.2024.07.050. Epub 2024 Aug 2.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
- Sürgősségi osztály
- Sürgősségi orvoslás
- Sérülések megelőzése
- Rövid beavatkozás
- Megvalósítás tudomány
- Beutalás a kezelésre
- Alkoholfogyasztási zavar (AUD)
- Alkoholszűrés
- Trauma ellátás
- Traumabetegek
- Közúti közlekedési sérülés
- Alcohol-Related Injury
- Screening, Brief Intervention, and Referral to Treatment (SBIRT)
- AUDIT-C
- Substance Use Intervention
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SBIRT_UB
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .