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

Alcohol Use Clinical Trial

— BNI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828267
• Other study ID #: Pro00062061
• Secondary ID: K01TW010000
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use

Intervention

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.
• Standard Booster
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.
• Personalized Booster
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.

Locations

Country	Name	City	State
Tanzania	Kilimanjaro Christian Medical Center	Moshi

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Fogarty International Center of the National Institute of Health, Kilimanjaro Christian Medical Centre, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	The average number of participants enrolled per week over the course of the study.	over the course of the study, approximately 8 months
Primary	Drinker Inventory of Consequences (DrInC) Score	The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Scales are combined to assess total adverse consequences, with higher scores indicating more adverse consequences. This is a mean and standard deviation of the number of consequences suffered by participants since enrollment. The total DrInC score is reported where is 0 (no consequences) to 50 (every consequence experienced).	6 weeks, 3 months, 6 months
Secondary	Retention Rates	Reported as the number of participants who complete each follow up visit.	6 weeks, 3 months, 6 months
Secondary	Alcohol Use Disorder Identification Test (AUDIT) Score	The AUDIT is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The scale ranges from 0 to 40; a score of 8 or more is considered to indicate hazardous or harmful alcohol use. Presented as the AUDIT mean score over the month prior to visit.	6 weeks, 3 months, 6 months