N/A
N=75
Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT02828267 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Enrollment Rate — 6.25 average participants per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Negotiational Intervention (Behavioral); Standard Booster (Behavioral); Personalized Booster (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
6.25 | — |
| PRIMARY Drinker Inventory of Consequences (DrInC) Score |
0.2; 0.9; 1.9; 0.3; 0.2; 0.4 | — |
| SECONDARY Retention Rates |
9; 15; 17; 19; 60; 10 | — |
| SECONDARY Alcohol Use Disorder Identification Test (AUDIT) Score |
0.33; 1.5; 1.9; 1.2; 0.7; 1.9 | — |
Summary
A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-30 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. Text based boosters have been proposed to prolong the impact of this intervention, either with a standardized or personalized content. The investigators will conduct a pilot study to test the feasibility of the study protocols, acceptance of the intervention, and patient enrollment and retention rates, as we prepare for a fully powered pragmatic randomized adaptive controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)
Eligibility Criteria
Inclusion Criteria
- >18 years of age
- be clinically sober at the time of enrollment
- have capacity to give informed consent
- converse in the local language Swahili or in English
- have either:
- reported ingesting alcohol in the 6 hours prior to injury,
- have a positive breathalyzer test, or
- have an Alcohol Use Disorder Identification Test with a score of ≥8.
Exclusion Criteria
- <18 years of age
- being clinically intoxicated
- being injured so severely that participants do not have the capacity to give informed consent
- not able to converse in Swahili or English
Data sourced from ClinicalTrials.gov (NCT02828267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.