Trial Outcomes & Findings for Screening, Brief Intervention, and Referral to Treatment in Primary Care (NCT NCT01966432)
NCT ID: NCT01966432
Last Updated: 2018-07-03
Results Overview
Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Baseline, Six Month Follow-up
Results posted on
2018-07-03
Participant Flow
Based on the results of the baseline substance use screen for the parent Southeastern Diabetes Initiative (SEDI) study at the Durham site, participants were categorized into three groups: Minimal-risk Screen (S) Group; At-risk Screen \& Brief Intervention (SBI) Group; and, High-risk Screen, Brief Intervention, \& Referral to Treatment (SBIRT) Group.
The clinical team consented 134 adults (84% of the eligible patients) for the SBIRT study. Of the 134 adults consented (enrolled), 36 are not accounted for in the results section (do not have baseline data).
Participant milestones
| Measure |
SBIRT Group
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
34
|
54
|
|
Overall Study
COMPLETED
|
5
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
13
|
26
|
Reasons for withdrawal
| Measure |
SBIRT Group
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
|
Overall Study
Subject Incarcerated
|
0
|
0
|
1
|
|
Overall Study
SBIRT program ended
|
1
|
8
|
20
|
Baseline Characteristics
Screening, Brief Intervention, and Referral to Treatment in Primary Care
Baseline characteristics by cohort
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
60 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Six Month Follow-upPopulation: All subjects who completed the assessments were included.
Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.
Outcome measures
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Drug Use Status and Frequency
Baseline
|
2.00 units on a scale
Interval 0.57 to 3.43
|
0.03 units on a scale
Interval 0.0 to 0.09
|
0.02 units on a scale
Interval 0.0 to 0.06
|
|
Drug Use Status and Frequency
Followup
|
0.60 units on a scale
Interval 0.0 to 1.71
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.00 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, Six Month Follow-upPopulation: All subjects who completed the assessments were included.
Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Outcome measures
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Cigarette Smoking Status and Nicotine Dependence
Baseline
|
1.50 units on a scale
Interval 0.02 to 2.98
|
2.91 units on a scale
Interval 2.01 to 3.81
|
0.00 units on a scale
Interval 0.0 to 0.0
|
|
Cigarette Smoking Status and Nicotine Dependence
Follow-up
|
1.60 units on a scale
Interval 0.0 to 4.84
|
2.78 units on a scale
Interval 1.71 to 3.85
|
0.00 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, Six Month Follow-upPopulation: All subjects who completed the assessments were included.
Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person's drinking is affecting his/her safety
Outcome measures
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Alcohol Use Status
Baseline
|
1.60 units on a scale
Interval 0.0 to 4.06
|
0.76 units on a scale
Interval 0.37 to 1.16
|
0.00 units on a scale
Interval 0.0 to 0.0
|
|
Alcohol Use Status
Follow-up
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.44 units on a scale
Interval 0.0 to 0.9
|
0.00 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, Six Month Follow-upPopulation: All subjects who completed the assessments were included.
For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit
Outcome measures
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Percentage of Participants Who Reported Substance Use at 6 Month
Baseline
|
30.0 percentage of participants
Interval 10.8 to 60.3
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Who Reported Substance Use at 6 Month
Followup
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, Six Month Follow-upPopulation: All subjects who completed the assessments were included.
Percentage of patients who received substance abuse or alcohol treatment (self reported)
Outcome measures
| Measure |
SBIRT Group
n=10 Participants
Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.
Referral to Treatment: Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
SBI Group
n=34 Participants
Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
|
S Group
n=54 Participants
Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.
|
|---|---|---|---|
|
Treatment for Drug Use or Alcohol
Baseline
|
20.0 percentage of participants
Interval 5.7 to 51.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
|
Treatment for Drug Use or Alcohol
Followup
|
20.0 percentage of participants
Interval 3.6 to 62.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
SBIRT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SBI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S Group
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
Dr. Li-Tzy Wu, Professor in Psychiatry
Duke University, Dept. of Psychiatry and Behavioral Sciences
Phone: (919) 889-9369
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place