Trial Outcomes & Findings for Screening to Augment Referral to Treatment- Project START (NCT NCT01539525)
NCT ID: NCT01539525
Last Updated: 2017-04-14
Results Overview
Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
439 participants
Primary outcome timeframe
7 non-overlapping monthly intervals from baseline to month 6
Results posted on
2017-04-14
Participant Flow
Participants were women (non-pregnant and pregnant) presenting for outpatient reproductive healthcare in an urban academic hospital-based clinic. Data collection occurred between April 20, 2011 and January 28, 2015.
Participant milestones
| Measure |
Motivational Interview-Nurse
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Overall Study
STARTED
|
145
|
143
|
151
|
|
Overall Study
COMPLETED
|
125
|
127
|
134
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
17
|
Reasons for withdrawal
| Measure |
Motivational Interview-Nurse
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
12
|
11
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
4
|
Baseline Characteristics
Screening to Augment Referral to Treatment- Project START
Baseline characteristics by cohort
| Measure |
Motivational Interview
n=145 Participants
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Electronic
n=143 Participants
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
n=151 Participants
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
Total
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 109 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
439 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Afican-American, non-Hispanic
|
102 participants
n=5 Participants
|
93 participants
n=7 Participants
|
98 participants
n=5 Participants
|
293 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian-American, non-Hispanic
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
23 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
24 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other race/ethnicity
|
5 participants
n=5 Participants
|
12 participants
n=7 Participants
|
6 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Marital Status
Married/living with partner
|
70 participants
n=5 Participants
|
54 participants
n=7 Participants
|
73 participants
n=5 Participants
|
197 participants
n=4 Participants
|
|
Marital Status
Other living situation
|
75 participants
n=5 Participants
|
89 participants
n=7 Participants
|
78 participants
n=5 Participants
|
242 participants
n=4 Participants
|
|
Pregnant
Pregnant
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
29 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Pregnant
Not pregnant
|
118 participants
n=5 Participants
|
119 participants
n=7 Participants
|
122 participants
n=5 Participants
|
359 participants
n=4 Participants
|
|
Education
Some high school or less
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
52 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
Education
High school graduate
|
64 participants
n=5 Participants
|
60 participants
n=7 Participants
|
57 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Education
Beyond high school
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
42 participants
n=5 Participants
|
110 participants
n=4 Participants
|
|
Education
missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Employment status
Full-time
|
18 participants
n=5 Participants
|
28 participants
n=7 Participants
|
20 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Employment status
Part-time
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
32 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Employment status
Not working
|
103 participants
n=5 Participants
|
89 participants
n=7 Participants
|
99 participants
n=5 Participants
|
291 participants
n=4 Participants
|
|
Primary Substance
Nicotine
|
81 participants
n=5 Participants
|
80 participants
n=7 Participants
|
90 participants
n=5 Participants
|
251 participants
n=4 Participants
|
|
Primary Substance
Alcohol
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
13 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Primary Substance
Cannabis
|
32 participants
n=5 Participants
|
27 participants
n=7 Participants
|
31 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Primary Substance
Other illicit drug
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
17 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Primary substance use
|
23.2 days per month
STANDARD_DEVIATION 8.3 • n=5 Participants
|
23.7 days per month
STANDARD_DEVIATION 7.7 • n=7 Participants
|
24.2 days per month
STANDARD_DEVIATION 7.7 • n=5 Participants
|
23.7 days per month
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Any substance use
|
26.0 days per month
STANDARD_DEVIATION 5.5 • n=5 Participants
|
25.4 days per month
STANDARD_DEVIATION 6.2 • n=7 Participants
|
25.7 days per month
STANDARD_DEVIATION 6.1 • n=5 Participants
|
25.7 days per month
STANDARD_DEVIATION 5.9 • n=4 Participants
|
|
Substance Use Disorders
Nicotine
|
81 participants
n=5 Participants
|
80 participants
n=7 Participants
|
90 participants
n=5 Participants
|
251 participants
n=4 Participants
|
|
Substance Use Disorders
Alcohol
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
13 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Substance Use Disorders
Cannabis
|
32 participants
n=5 Participants
|
27 participants
n=7 Participants
|
31 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Substance Use Disorders
Other illicit drug
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
17 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Alcohol, Smoking, and Substance Involvement Screening Test Score
|
22.5 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 8.5 • n=7 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
22.5 units on a scale
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Fagerstrom Test for Nicotine Dependence Score
|
3.8 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 7 non-overlapping monthly intervals from baseline to month 6Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Outcome measures
| Measure |
Motivational Interview-Nurse
n=145 Participants
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
n=143 Participants
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
n=151 Participants
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Days Per Month of Primary Substance Use
baseline
|
23.2 days per month
Standard Deviation 8.3
|
23.7 days per month
Standard Deviation 7.7
|
24.2 days per month
Standard Deviation 7.7
|
|
Days Per Month of Primary Substance Use
Month 1
|
19.3 days per month
Standard Deviation 11.2
|
19.7 days per month
Standard Deviation 11.2
|
22.8 days per month
Standard Deviation 8.9
|
|
Days Per Month of Primary Substance Use
Month 2
|
18.7 days per month
Standard Deviation 11.8
|
17.9 days per month
Standard Deviation 12.1
|
22.2 days per month
Standard Deviation 10.1
|
|
Days Per Month of Primary Substance Use
Month 3
|
18.0 days per month
Standard Deviation 12.0
|
17.8 days per month
Standard Deviation 11.9
|
21.4 days per month
Standard Deviation 10.6
|
|
Days Per Month of Primary Substance Use
Month 4
|
18.0 days per month
Standard Deviation 12.2
|
16.8 days per month
Standard Deviation 12.3
|
20.0 days per month
Standard Deviation 11.4
|
|
Days Per Month of Primary Substance Use
Month 5
|
17.6 days per month
Standard Deviation 12.5
|
16.3 days per month
Standard Deviation 12.6
|
19.7 days per month
Standard Deviation 11.4
|
|
Days Per Month of Primary Substance Use
Month 6
|
17.0 days per month
Standard Deviation 12.3
|
16.2 days per month
Standard Deviation 12.5
|
19.1 days per month
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: baseline to 6 monthsTreatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).
Outcome measures
| Measure |
Motivational Interview-Nurse
n=145 Participants
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
n=143 Participants
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
n=151 Participants
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Treatment Utilization
utilized treatment
|
39 participants
|
39 participants
|
43 participants
|
|
Treatment Utilization
no tretment
|
106 participants
|
104 participants
|
108 participants
|
SECONDARY outcome
Timeframe: baseline to 6 monthsrates of incident std's per patient's medical records
Outcome measures
| Measure |
Motivational Interview-Nurse
n=145 Participants
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
n=143 Participants
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
n=151 Participants
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Rates of STDs
Incident case
|
8 participants
|
4 participants
|
6 participants
|
|
Rates of STDs
Non-incident case
|
135 participants
|
138 participants
|
152 participants
|
|
Rates of STDs
Missing
|
2 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data.
The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs
Outcome measures
| Measure |
Motivational Interview-Nurse
n=115 participants
Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Motivational Interview-Computer
n=123 participants
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
|
Treatment as Usual
n=133 participants
No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area.
|
|---|---|---|---|
|
Mean Cost for Each Intervention
|
57.56 dollars
Standard Deviation 16.12
|
21.07 dollars
Standard Deviation 4.43
|
21.21 dollars
Standard Deviation 7.3
|
Adverse Events
Motivational Interview
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interview-Electronic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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