Clinical Trial: Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania

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 (5-60 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. 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 randomized controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)

Detailed Summary:

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

Participants and Recruitment: The investigators will prospectively enroll (n=60, 30 intervention, 30 control) 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: Both groups will provide two phone numbers where participants can be reached in order to facilitate follow-up. All participants will be contacted at 30, 60, and 120 days for follow-up survey administration. 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: 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 Observations 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 real-time observations of BNI administration using the BNI Assessment Scale.

Intervention and Trial Acceptability: The investigators
Sponsor: Duke University

Current Primary Outcome: Recruitment Rates [ Time Frame: 4 months ]

The primary outcome will be delineating the recruitment rates estimated at 30%. This outcome will inform the fully powered randomized controlled trial


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Retention Rates [ Time Frame: 30 day follow up ]
  • Retention Rates [ Time Frame: 60 day follow up ]
  • Retention Rates [ Time Frame: 120 day follow up ]
  • Change in retention rates [ Time Frame: baseline, 4 months ]
  • Acceptability of participation in trial and intervention as measured by questionnaire [ Time Frame: 4 months ]


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: July 6, 2016
Date Started: July 1, 2018
Date Completion: June 2019
Last Updated: January 31, 2017
Last Verified: July 2016