Trial Outcomes & Findings for Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments (NCT NCT02586896)
NCT ID: NCT02586896
Last Updated: 2020-05-05
Results Overview
"Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
3 months
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
Strengths-based Case Management (SBCM)
The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance.
The six case management sessions for this trial were based on those described in manuals developed by Dr. Rapp for two previous clinical trials. Each session was guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence. Initiation of the relationship between client and case manager began immediately following random assignment and termination took place when either (1) six sessions had occurred; (2) ninety days had elapsed; or (3) clients discontinued involvement.
|
Screening, Assessment and Referral (SAR)
Participants in the SAR condition were provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. The research assistant provided SAR participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet included names, addresses, and phone numbers of local addiction treatment agencies. Participants also received an informational pamphlet about drug use and its consequences, addiction, and treatment.
Because the emergency department does not currently screen or refer systematically, the SAR condition represented a level of care significantly higher than "treatment as usual."
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
3-Month Follow-up
|
126
|
123
|
|
Overall Study
COMPLETED
|
131
|
133
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
Baseline characteristics by cohort
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Participants received up to six sessions of Strengths-based Case Management (SBCM) within 90 days of randomization.
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Participants received a detailed referral sheet, an informational pamphlet, and scripted feedback recommending they seek treatment.
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Asian-American/Pacific Islander
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Cuban
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Mexican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, New Mexican/Spanish-American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Puerto Rican
|
43 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Other Latin American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic origin
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other ethnic group
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to treat
"Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Initiation of Treatment for Opioid Dependence
Initiated
|
85 Participants
|
74 Participants
|
|
Initiation of Treatment for Opioid Dependence
Did Not Initiate
|
63 Participants
|
75 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to treat
Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Engagement in Treatment for Opioid Dependence
|
21.77 % days
Standard Deviation 35.07
|
17.72 % days
Standard Deviation 30.99
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat
"Successful outcome" will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Number of Participants With Successful Outcome for Opioid Use
No successful outcome
|
107 Participants
|
121 Participants
|
|
Number of Participants With Successful Outcome for Opioid Use
Successful outcome
|
41 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire
|
11.23 units on a scale
Standard Deviation 4.61
|
11.22 units on a scale
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat
"Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Initiation in Participants With Higher Levels of Environmental Instability at Baseline
|
62.5 % of participants
Standard Error 7.8
|
57.8 % of participants
Standard Error 7.2
|
SECONDARY outcome
Timeframe: 3 monthsUsing the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.
Outcome measures
| Measure |
Strengths-based Case Management (SBCM)
n=148 Participants
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=149 Participants
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Engagement in Participants With Higher Levels of Environmental Instability at Baseline
|
22.16 % days
Standard Error 5.21
|
19.89 % days
Standard Error 4.76
|
Adverse Events
Strengths-based Case Management (SBCM)
Serious events: 17 serious events
Other events: 3 other events
Deaths: 4 deaths
Screening, Assessment and Referral (SAR)
Serious events: 8 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Strengths-based Case Management (SBCM)
n=150 participants at risk
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=150 participants at risk
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
General disorders
Death (cause unknown)
|
2.0%
3/150 • Number of events 3 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Hepatobiliary disorders
Hepatobiliary disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Psychiatric disorders
Psychiatric disorders
|
6.7%
10/150 • Number of events 11 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
3.3%
5/150 • Number of events 6 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Surgical and medical procedures
Withdrawal of life support
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
Other adverse events
| Measure |
Strengths-based Case Management (SBCM)
n=150 participants at risk
Strengths-based Case Management (SBCM)
|
Screening, Assessment and Referral (SAR)
n=150 participants at risk
Screening, Assessment and Referral (SAR)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Infections and infestations
Infection
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Vascular disorders
Vascular disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
|
Cardiac disorders
Cardiac disorder
|
0.67%
1/150 • Number of events 1 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
0.00%
0/150 • Consent through final 6-month follow-up
Events not meeting the study definition of AE: * Mild unrelated event * Moderate unrelated event * Substance use events (e.g., worsening drug use, need for higher level of care, withdrawal symptoms, craving, related medical events) Events not meeting the study definition of SAE: * Admission for drug detox/treatment * Admission for preplanned surgeries * Admission for scheduled labor/delivery * Admission for a medical event, unless severe, life threatening, or resulting in death
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place