Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania (BNI)
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|ClinicalTrials.gov Identifier: NCT02828267|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use||Behavioral: Brief Negotiational Intervention||Not Applicable|
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 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.
Enrollment and Retention: The primary outcome measure will be recruitment and retention rates, anticipated at 30% and 80%, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
No Intervention: Usual Care
In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
In the BNI arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.
Behavioral: Brief Negotiational Intervention
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.
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828267
|Contact: Catherine A. Staton, MD, MSc||+1 (919) firstname.lastname@example.org|
|Kilimanjaro Christian Medical Center||Recruiting|
|Contact: Catherine S. Staton, MD email@example.com|
|Contact: Blandina Mmbaga, MD firstname.lastname@example.org|
|Principal Investigator:||Catherine A. Staton, MD, MSc||Duke University|