Trial Outcomes & Findings for Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania (NCT NCT02828267)
NCT ID: NCT02828267
Last Updated: 2021-08-11
Results Overview
The average number of participants enrolled per week over the course of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
over the course of the study, approximately 8 months
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
Usual Care
In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
|
Brief Negotiational Interview (BNI)
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.
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.
|
BNI Plus Standard Booster
In the BNI plus standard booster arm, patients will receive a 5-10 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.
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.
|
BNI Plus Personalized Booster
In the BNI plus personalized booster arm, patients will receive a 5-10 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. 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.
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.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
21
|
24
|
20
|
|
Overall Study
COMPLETED
|
10
|
21
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Baseline characteristics by cohort
| Measure |
Usual Care
n=10 Participants
In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
|
Brief Negotiational Interview (BNI)
n=21 Participants
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.
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.
|
BNI Plus Standard Booster
n=24 Participants
In the BNI plus standard booster arm, patients will receive a 5-10 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.
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.
|
BNI Plus Personalized Booster
n=20 Participants
In the BNI plus personalized booster arm, patients will receive a 5-10 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. 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.
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.
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 12.8 • n=93 Participants
|
40.6 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
36.6 years
STANDARD_DEVIATION 14.5 • n=27 Participants
|
31.4 years
STANDARD_DEVIATION 11.8 • n=483 Participants
|
36.3 years
STANDARD_DEVIATION 13.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
72 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Tanzania
|
10 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Drinker Inventory of Consequences (DrInC)
|
14.7 score on a scale
STANDARD_DEVIATION 8.0 • n=93 Participants
|
20.3 score on a scale
STANDARD_DEVIATION 7.3 • n=4 Participants
|
16.0 score on a scale
STANDARD_DEVIATION 10.3 • n=27 Participants
|
15.0 score on a scale
STANDARD_DEVIATION 8.7 • n=483 Participants
|
16.8 score on a scale
STANDARD_DEVIATION 8.9 • n=36 Participants
|
|
Alcohol Use Disorder Identification Test (AUDIT) Score
|
9.7 score on a scale
STANDARD_DEVIATION 3.8 • n=93 Participants
|
13.9 score on a scale
STANDARD_DEVIATION 6.4 • n=4 Participants
|
12.1 score on a scale
STANDARD_DEVIATION 6.5 • n=27 Participants
|
12.9 score on a scale
STANDARD_DEVIATION 7.2 • n=483 Participants
|
12.5 score on a scale
STANDARD_DEVIATION 6.4 • n=36 Participants
|
PRIMARY outcome
Timeframe: over the course of the study, approximately 8 monthsThe average number of participants enrolled per week over the course of the study.
Outcome measures
| Measure |
Total Enrolled Patient Sample
n=75 Participants
All feasibility trial arms
|
BNI Only
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.
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.
|
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.
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.
|
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.
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.
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.
|
All Trial Participants
Total participants in the feasibility trial.
|
|---|---|---|---|---|---|
|
Enrollment Rate
|
6.25 average participants per week
Interval 3.0 to 9.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 weeks, 3 months, 6 monthsPopulation: Participants who completed the specific follow up time point were included in the analysis.
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).
Outcome measures
| Measure |
Total Enrolled Patient Sample
n=10 Participants
All feasibility trial arms
|
BNI Only
n=21 Participants
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.
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.
|
BNI Plus Standard Booster
n=24 Participants
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.
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.
|
BNI Plus Personalized Booster
n=20 Participants
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.
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.
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.
|
All Trial Participants
Total participants in the feasibility trial.
|
|---|---|---|---|---|---|
|
Drinker Inventory of Consequences (DrInC) Score
6 weeks
|
0.2 score on the total scale
Standard Deviation 0.7
|
0.9 score on the total scale
Standard Deviation 1.8
|
1.9 score on the total scale
Standard Deviation 7.8
|
0.3 score on the total scale
Standard Deviation 0.9
|
—
|
|
Drinker Inventory of Consequences (DrInC) Score
3 months
|
0.2 score on the total scale
Standard Deviation 0.6
|
0.4 score on the total scale
Standard Deviation 1.1
|
2.4 score on the total scale
Standard Deviation 8.5
|
0.7 score on the total scale
Standard Deviation 1.2
|
—
|
|
Drinker Inventory of Consequences (DrInC) Score
6 months
|
1.3 score on the total scale
Standard Deviation 3.5
|
1.2 score on the total scale
Standard Deviation 3.2
|
1.0 score on the total scale
Standard Deviation 3.1
|
0.7 score on the total scale
Standard Deviation 1.5
|
—
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 6 monthsReported as the number of participants who complete each follow up visit.
Outcome measures
| Measure |
Total Enrolled Patient Sample
n=10 Participants
All feasibility trial arms
|
BNI Only
n=21 Participants
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.
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.
|
BNI Plus Standard Booster
n=24 Participants
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.
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.
|
BNI Plus Personalized Booster
n=20 Participants
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.
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.
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.
|
All Trial Participants
n=75 Participants
Total participants in the feasibility trial.
|
|---|---|---|---|---|---|
|
Retention Rates
6 weeks
|
9 Participants
|
15 Participants
|
17 Participants
|
19 Participants
|
60 Participants
|
|
Retention Rates
3 months
|
10 Participants
|
15 Participants
|
20 Participants
|
17 Participants
|
62 Participants
|
|
Retention Rates
6 months
|
10 Participants
|
17 Participants
|
19 Participants
|
17 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 6 monthsPopulation: Only those participants who were retained on follow up were analyzed.
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.
Outcome measures
| Measure |
Total Enrolled Patient Sample
n=10 Participants
All feasibility trial arms
|
BNI Only
n=21 Participants
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.
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.
|
BNI Plus Standard Booster
n=24 Participants
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.
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.
|
BNI Plus Personalized Booster
n=20 Participants
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.
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.
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.
|
All Trial Participants
Total participants in the feasibility trial.
|
|---|---|---|---|---|---|
|
Alcohol Use Disorder Identification Test (AUDIT) Score
6 weeks
|
0.33 score on a scale
Standard Deviation 1.0
|
1.5 score on a scale
Standard Deviation 2.5
|
1.9 score on a scale
Standard Deviation 5.3
|
1.2 score on a scale
Standard Deviation 1.4
|
—
|
|
Alcohol Use Disorder Identification Test (AUDIT) Score
3 months
|
0.7 score on a scale
Standard Deviation 0.9
|
1.9 score on a scale
Standard Deviation 1.3
|
2.9 score on a scale
Standard Deviation 5.0
|
2.7 score on a scale
Standard Deviation 1.4
|
—
|
|
Alcohol Use Disorder Identification Test (AUDIT) Score
6 months
|
4.4 score on a scale
Standard Deviation 5.3
|
4.0 score on a scale
Standard Deviation 4.1
|
3.3 score on a scale
Standard Deviation 2.3
|
4.9 score on a scale
Standard Deviation 2.6
|
—
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI Plus Standard Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI Plus Personalized Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place