Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Condition: Alcohol Use
MeSH terms: Alcohol Drinking
Study type: Interventional

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.
    

Intervention name(s): Brief Negotiational Intervention; Standard Booster; Personalized Booster
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.; This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use.; This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tanzania; Alcohol Use; Brief Intervention