Clinical trial NCT02828267: Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Official title: Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use
Keywords: Tanzania
Alcohol Use
Brief Intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kilimanjaro Christian Medical Centre, Tanzania
name: Fogarty International Center of the National Institute of Health
First posted: 2016-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an feasiblity trial of a three stage adaptive clinical trial. Stage one has three arms (UC, BNI, BNI+ Standard booster). Stage two drops usual care arm. Stage three continues the strongest arm for phase two (which was choosen as BNI + Standard Booster for this feasiblity trial not powered to determine efficacy) and a new arm BNI + Personalized Booster.
Primary purpose: PREVENTION

Brief 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)

Detailed description: Research Design: This will be a pilot randomized adaptive feasibility and acceptability trial.

This will be a three stage trial where usual care, brief intervention and brief intervention with standard booster will be in the first stage. The second stage will drop the usual care arm. The third stage will keep an arm in stage two and a new arm, brief intervention with personalized booster. Since this is a feasibility trial, we will advance through potential adaptations, changing the enrollment procedures but not based on effectiveness testing as we are not powered for that endpoint. We have chosen brief intervention with standardized booster to continue in stage 3 to obtain more patient experience with the booster portion of the intervention.

Participants and Recruitment: The investigators will prospectively enroll (n=75, 10 usual care, 20 BNI, 24 BNI + standard booster and 16 BNI + Personalized Booster) patients who present to the KCMC ED for care of acute injuries and meet inclusion and exclusion criteria. Trained research nurses will describe the intervention as a health assessment, and eligible interested participants will be enrolled, provide informed consent and a randomization packet chosen. The research nurses will then administer patient demographic, injury, alcohol use surveys and the intervention if appropriate all lasting less than 45 minutes.

Follow-up Procedures: All groups will provide two phone numbers where participants can be reached in order to facilitate follow-up. All participants will be contacted at 6 weeks, 3 months and 6 months for follow-up survey administration. Follow up surveys are expected to be less than 20 minutes. All patients will be contacted by text message at the conclusion of the study to inform them about availability of the results of the study.

Feasibility Trial Outcomes: Using the RE-AIM framework, we will define the reach (enrollment/ retention), the preliminary effectiveness (reduction in DrInC score), adoption including patient acceptance, implementation (intervention fidelity) and maintance (sustainability features). The investigators will conduct a feasibility assessment subjectively through self-assessments as well as objectively through Event Analyses, understanding causes of deviations from protocol, intervention evaluations and questionnaires.

Study Procedures: To evaluate the study procedures, the investigators will evaluate any protocol deviation events, and compare length of survey times. The investigators will also perform assessments of intervention fidelity through reviewing recorded observations of BNI administration using the BNI Assessment Scale.

Reach: Enrollment and Retention The primary outcome measure will be recruitment and retention rates, anticipated at 30% and 60%, respectively. Secondarily, the investigators will qualitatively assess the inclusion and exclusion criteria, reasons for non-enrollment or non-retention, to the extent possible. Finally, the investigators will administer follow-up questions about compensation procedures in order to improve enrollment or retention.

Effectiveness: We will evaluate the DrInC (Drinker Inventory of Consequences), AUDIT (Alcohol Use Disorder Identification Test) scores, number of drinking days and number of binge drinking days. We are not powered to determine effectiveness, so this is a preliminary effectiveness only.

Adoption: We will evaluate patient acceptance and perception of effectiveness for the adoption of this intervention. The investigators will assess acceptability of participation in the trial and intervention through questions administered after the final follow-up time point for both the research team as well as participants. This will include assessment about the length of surveys, and method and quantity of follow-up.

Implementation: We will evaluate implementation preparedness with an evaluation of the time burden of the BNI, and intervention fidelity both for the BNI, and SMS boosters but also trial protocols.

Maintenance: We will determine sustainability through the burden of administration of the BNI as perceived by research nurses administering the intervention, the attitudes towards effectiveness of interventionists and participants, the cost and feasibility of this type of this adaptive clinical trial in this setting.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: over the course of the study, approximately 8 months
measure: Drinker Inventory of Consequences (DrInC) Score
timeFrame: 6 weeks, 3 months, 6 months
Secondary outcomes:
measure: Retention Rates
timeFrame: 6 weeks, 3 months, 6 months
measure: Alcohol Use Disorder Identification Test (AUDIT) Score
timeFrame: 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Center
Study officials:
affiliation: Duke University
name: Catherine A. Staton, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: