Trial Outcomes & Findings for Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department (NCT NCT00913770)
NCT ID: NCT00913770
Last Updated: 2020-03-24
Results Overview
Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
329 participants
Primary outcome timeframe
30 days post randomization
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Standard Care
Standard Care including receiving a referral.
|
SBIRT
Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
|
SBI+Bup
Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
111
|
114
|
|
Overall Study
COMPLETED
|
69
|
82
|
93
|
|
Overall Study
NOT COMPLETED
|
35
|
29
|
21
|
Reasons for withdrawal
| Measure |
Standard Care
Standard Care including receiving a referral.
|
SBIRT
Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
|
SBI+Bup
Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.
|
|---|---|---|---|
|
Overall Study
Unable to contact
|
24
|
19
|
13
|
|
Overall Study
Refused
|
11
|
10
|
8
|
Baseline Characteristics
Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Baseline characteristics by cohort
| Measure |
Standard Care
n=104 Participants
Standard Care including receiving a referral.
|
SBIRT
n=111 Participants
Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
|
SBI+Bup
n=114 Participants
Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
31 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days post randomizationPopulation: All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.
Outcome measures
| Measure |
Standard Care
n=102 Participants
Standard Care including receiving a referral.
|
SBIRT
n=111 Participants
Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
|
SBI+Bup
n=114 Participants
Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.
|
|---|---|---|---|
|
Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)
|
4.99 Mean Number of Outpatient Visits
Interval 3.1 to 6.8
|
5.67 Mean Number of Outpatient Visits
Interval 4.0 to 7.4
|
3.71 Mean Number of Outpatient Visits
Interval 2.1 to 5.3
|
SECONDARY outcome
Timeframe: 30 days post randomizationPopulation: All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104
Outcome measures
| Measure |
Standard Care
n=102 Participants
Standard Care including receiving a referral.
|
SBIRT
n=111 Participants
Screening, Brief Intervention and Facilitated Referral to Treatment
Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
|
SBI+Bup
n=114 Participants
Screening, Brief Intervention and Buprenorphine initiation
Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly.
|
|---|---|---|---|
|
Days of Self-reported Illicit Opioid Use in the Past 7 Days
|
2.3 Mean Number of Days
Interval 1.7 to 3.0
|
2.4 Mean Number of Days
Interval 1.8 to 3.0
|
0.9 Mean Number of Days
Interval 0.5 to 1.3
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SBIRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SBI+Bup
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