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

NCT ID: NCT02828267

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-03-01

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.

Conditions

Alcohol Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction

Group Type: NO_INTERVENTION

No interventions assigned to this group

BNI

In the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.

Group Type: EXPERIMENTAL

Brief Negotiational Intervention

Intervention Type: BEHAVIORAL

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.

BNI plus standard booster

In the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.

Group Type: ACTIVE_COMPARATOR

Brief Negotiational Intervention

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

BNI plus personalized booster

In the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.

Group Type: ACTIVE_COMPARATOR

Brief Negotiational Intervention

Intervention Type: BEHAVIORAL

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.

Personalized Booster

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kilimanjaro Christian Medical Centre, Tanzania

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine A. Staton, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Kilimanjaro Christian Medical Center

Moshi, , Tanzania

Countries

Tanzania

References

Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.

Reference Type: DERIVED

PMID: 39052647 (View on PubMed)

Staton CA, Friedman K, Phillips AJ, Minnig MC, Sakita FM, Ngowi KM, Suffoletto B, Hirshon JM, Swahn M, Mmbaga BT, Vissoci JRN. Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania. PLoS One. 2023 Aug 3;18(8):e0288458. doi: 10.1371/journal.pone.0288458. eCollection 2023.

Reference Type: DERIVED

PMID: 37535693 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K01TW010000

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00062061

Identifier Type: -

Identifier Source: org_study_id