Trial Outcomes & Findings for Prevention Interventions for Opioid Misuse (NCT NCT04550715)
NCT ID: NCT04550715
Last Updated: 2026-08-03
Results Overview
Alcohol Smoking and Substance Involvement Screening Test severity score (severity of prescription opioids/heroin, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1155 participants
Primary outcome timeframe
3, 6, and 12 months
Results posted on
2026-08-03
Participant Flow
Recruitment occurred from January 2021 through February 2024 with patients who were attending the Emergency Department or had a recent Emergency Department visit.
N/A, randomization was the point of enrollment in this study.
Participant milestones
| Measure |
Brief Intervention (BI) Then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Baseline Enrollment
STARTED
|
284
|
286
|
295
|
290
|
|
Baseline Enrollment
COMPLETED
|
284
|
286
|
295
|
290
|
|
Baseline Enrollment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Completion
STARTED
|
284
|
286
|
295
|
290
|
|
Intervention Completion
Assigned to BI Then Enhanced Usual Care; But Completed BI Then Portal by Mistake
|
1
|
0
|
0
|
0
|
|
Intervention Completion
COMPLETED
|
260
|
259
|
294
|
290
|
|
Intervention Completion
NOT COMPLETED
|
24
|
27
|
1
|
0
|
|
3-month Follow-up
STARTED
|
284
|
286
|
295
|
290
|
|
3-month Follow-up
COMPLETED
|
250
|
259
|
266
|
274
|
|
3-month Follow-up
NOT COMPLETED
|
34
|
27
|
29
|
16
|
|
6-month Follow-up
STARTED
|
284
|
286
|
295
|
290
|
|
6-month Follow-up
COMPLETED
|
241
|
250
|
270
|
272
|
|
6-month Follow-up
NOT COMPLETED
|
43
|
36
|
25
|
18
|
|
12-month Follow-up
STARTED
|
284
|
286
|
295
|
290
|
|
12-month Follow-up
COMPLETED
|
227
|
242
|
265
|
264
|
|
12-month Follow-up
NOT COMPLETED
|
57
|
44
|
30
|
26
|
Reasons for withdrawal
| Measure |
Brief Intervention (BI) Then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Intervention Completion
Withdrawal by Subject
|
4
|
3
|
0
|
0
|
|
Intervention Completion
Refused
|
19
|
24
|
1
|
0
|
|
Intervention Completion
Randomization error
|
1
|
0
|
0
|
0
|
|
3-month Follow-up
Lost to Follow-up
|
26
|
21
|
28
|
14
|
|
3-month Follow-up
Withdrawal by Subject
|
5
|
5
|
0
|
2
|
|
3-month Follow-up
Death
|
1
|
1
|
1
|
0
|
|
3-month Follow-up
Refused
|
2
|
0
|
0
|
0
|
|
6-month Follow-up
Lost to Follow-up
|
34
|
29
|
24
|
12
|
|
6-month Follow-up
Withdrawal by Subject
|
7
|
5
|
0
|
5
|
|
6-month Follow-up
Death
|
1
|
2
|
1
|
0
|
|
6-month Follow-up
Refused
|
1
|
0
|
0
|
1
|
|
12-month Follow-up
Lost to Follow-up
|
46
|
35
|
28
|
20
|
|
12-month Follow-up
Withdrawal by Subject
|
7
|
6
|
0
|
5
|
|
12-month Follow-up
Death
|
3
|
2
|
1
|
1
|
|
12-month Follow-up
Refused
|
1
|
0
|
1
|
0
|
|
12-month Follow-up
No longer able to consent
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Prevention Interventions for Opioid Misuse
Baseline characteristics by cohort
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Total
n=1155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
19 Participants
n=6 Participants
|
79 Participants
n=7 Participants
|
|
Age, Customized
16-25 years
|
190 Participants
n=20 Participants
|
194 Participants
n=20 Participants
|
198 Participants
n=40 Participants
|
195 Participants
n=6 Participants
|
777 Participants
n=7 Participants
|
|
Age, Customized
26-30 years
|
94 Participants
n=20 Participants
|
92 Participants
n=20 Participants
|
97 Participants
n=40 Participants
|
95 Participants
n=6 Participants
|
378 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=20 Participants
|
209 Participants
n=20 Participants
|
214 Participants
n=40 Participants
|
210 Participants
n=6 Participants
|
837 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=20 Participants
|
77 Participants
n=20 Participants
|
81 Participants
n=40 Participants
|
80 Participants
n=6 Participants
|
318 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
21 Participants
n=6 Participants
|
61 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
57 Participants
n=40 Participants
|
40 Participants
n=6 Participants
|
190 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
204 Participants
n=20 Participants
|
198 Participants
n=20 Participants
|
203 Participants
n=40 Participants
|
208 Participants
n=6 Participants
|
813 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
29 Participants
n=6 Participants
|
102 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
259 Participants
n=20 Participants
|
267 Participants
n=20 Participants
|
266 Participants
n=40 Participants
|
261 Participants
n=6 Participants
|
1053 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3, 6, and 12 monthsAlcohol Smoking and Substance Involvement Screening Test severity score (severity of prescription opioids/heroin, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed.
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Opioid Misuse
Baseline
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
|
Opioid Misuse
3-months
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
|
Opioid Misuse
6-months
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
|
Opioid Misuse
12-months
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
0 Scores on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsOpioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes)
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Overdose Risk Behaviors
12-months
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Overdose Risk Behaviors
6-months
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Overdose Risk Behaviors
Baseline
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Overdose Risk Behaviors
3-months
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsItem based on the Addiction Severity Index (modified), data was collected for days of opioid misuse and possible scores ranged from 0-60. For statistical analysis, responses were dichotomized to 0 days vs. 1+ days, thus results are presented as # of participants reporting past 30-day opioid misuse.
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)
Baseline
|
13 Participants w/ past 30day opioid misuse
|
14 Participants w/ past 30day opioid misuse
|
20 Participants w/ past 30day opioid misuse
|
15 Participants w/ past 30day opioid misuse
|
|
Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)
3-Months
|
6 Participants w/ past 30day opioid misuse
|
11 Participants w/ past 30day opioid misuse
|
10 Participants w/ past 30day opioid misuse
|
3 Participants w/ past 30day opioid misuse
|
|
Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)
6-Months
|
11 Participants w/ past 30day opioid misuse
|
6 Participants w/ past 30day opioid misuse
|
13 Participants w/ past 30day opioid misuse
|
5 Participants w/ past 30day opioid misuse
|
|
Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)
12-Months
|
17 Participants w/ past 30day opioid misuse
|
7 Participants w/ past 30day opioid misuse
|
7 Participants w/ past 30day opioid misuse
|
4 Participants w/ past 30day opioid misuse
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsSubstance use severity index (based on 7-items measuring frequency of: alcohol consumption, cannabis consumption, prescription sedative misuse, prescription stimulant misuse, cocaine consumption, methamphetamine consumption, hallucinogens consumption), sum of all 7 items with response options for each substance: 0 = never, 1= 1 time, 2= 2 times, 3= Once a month, 4= 2 to 3 times a month, 5= Once a week, 6= 2 times a week, 7= 3 to 4 times a week, 8= Nearly every day, 9= Every day, 10= More than once a day; total possible range is 0-70, higher scores indicate worse outcome/greater severity
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Other Drug and Alcohol Use Severity
Baseline
|
8 scores on a scale
Interval 4.0 to 12.0
|
6.5 scores on a scale
Interval 4.0 to 11.0
|
6 scores on a scale
Interval 4.0 to 10.0
|
7 scores on a scale
Interval 4.0 to 11.0
|
|
Other Drug and Alcohol Use Severity
3-months
|
7 scores on a scale
Interval 4.0 to 11.0
|
7 scores on a scale
Interval 4.0 to 11.0
|
6 scores on a scale
Interval 3.0 to 10.0
|
7 scores on a scale
Interval 4.0 to 11.0
|
|
Other Drug and Alcohol Use Severity
6-months
|
7 scores on a scale
Interval 4.0 to 11.0
|
7 scores on a scale
Interval 4.0 to 11.0
|
6 scores on a scale
Interval 3.0 to 10.0
|
7 scores on a scale
Interval 3.0 to 11.0
|
|
Other Drug and Alcohol Use Severity
12-months
|
7 scores on a scale
Interval 4.0 to 11.0
|
6.5 scores on a scale
Interval 4.0 to 11.0
|
6 scores on a scale
Interval 2.0 to 10.0
|
7 scores on a scale
Interval 4.0 to 11.0
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsAdapted alcohol (14 items), cannabis (14 items), and/or opioid-related consequences (14 items); response options for each item on each subscale were: 0=Never, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20 or more times. Measure comprises total of sum of items across 3 subscales with a possible range of 0 to 252, higher score indicates worse outcomes/more consequences
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Substance Use Consequences
Baseline
|
12.5 scores on a scale
Interval 4.0 to 27.0
|
12 scores on a scale
Interval 3.0 to 23.0
|
12 scores on a scale
Interval 4.0 to 25.0
|
11.5 scores on a scale
Interval 3.0 to 22.0
|
|
Substance Use Consequences
3-months
|
6 scores on a scale
Interval 1.0 to 20.0
|
6 scores on a scale
Interval 1.0 to 17.0
|
6 scores on a scale
Interval 1.0 to 19.0
|
6 scores on a scale
Interval 1.0 to 16.0
|
|
Substance Use Consequences
6-months
|
5 scores on a scale
Interval 1.0 to 16.0
|
5 scores on a scale
Interval 1.0 to 15.0
|
6 scores on a scale
Interval 1.0 to 15.0
|
6 scores on a scale
Interval 1.0 to 17.0
|
|
Substance Use Consequences
12-months
|
5 scores on a scale
Interval 0.0 to 15.0
|
6 scores on a scale
Interval 0.0 to 16.0
|
5 scores on a scale
Interval 0.0 to 15.0
|
5 scores on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsAdapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome)
Outcome measures
| Measure |
Brief Intervention (BI) Then Portal
n=284 Participants
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 Participants
The BI will be delivered at intake and EUC will be added 4 weeks later. Prescription disposal bag provided.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 Participants
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. Prescription disposal bag provided.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 Participants
EUC will be delivered at intake and delivered again 4 weeks later. Prescription disposal bag provided.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
Impaired Driving
6-months
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Impaired Driving
12-months
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Impaired Driving
Baseline
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Impaired Driving
3-months
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
Adverse Events
Brief Intervention (BI) Then Portal
Serious events: 17 serious events
Other events: 0 other events
Deaths: 3 deaths
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 2 deaths
Enhanced Usual Care (EUC) Then Portal
Serious events: 15 serious events
Other events: 1 other events
Deaths: 1 deaths
Enhanced Usual Care (EUC) Then EUC
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Brief Intervention (BI) Then Portal
n=284 participants at risk
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 participants at risk
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 participants at risk
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 participants at risk
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
3.2%
9/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.68%
2/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
General disorders
Death
|
1.1%
3/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.70%
2/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.34%
1/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Surgical and medical procedures
Hospitalization
|
0.70%
2/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
1.0%
3/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.69%
2/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
1.0%
3/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Cardiac disorders
Hospitalization
|
0.00%
0/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.34%
1/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Infections and infestations
Hospitalization
|
0.35%
1/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.35%
1/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Psychiatric disorders
Hospitalization
|
0.70%
2/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.70%
2/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
1.7%
5/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
1.4%
4/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
|
Psychiatric disorders
Death
|
0.00%
0/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.34%
1/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
Other adverse events
| Measure |
Brief Intervention (BI) Then Portal
n=284 participants at risk
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
|
Brief Intervention (BI) Then Enhanced Usual Care (EUC)
n=286 participants at risk
The BI will be delivered at intake and EUC will be added 4 weeks later.
Brief intervention (BI): A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then Portal
n=295 participants at risk
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake.
Portal: Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
Enhanced Usual Care (EUC) Then EUC
n=290 participants at risk
EUC will be delivered at intake and delivered again 4 weeks later.
Enhanced Usual Care (EUC): The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
|
|---|---|---|---|---|
|
General disorders
Emergency Visit
|
0.00%
0/284 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/286 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.34%
1/295 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
0.00%
0/290 • From enrollment til end of follow-up (12 months)
Adverse events were standard for behavioral studies and could include deaths, hospitalizations, inpatient rehabilitation programs, etc.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place